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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women With Osteoporosis

    Summary
    EudraCT number
    		 2012-001921-29
    Trial protocol
    		 PL   EE   DK   LT  
    Global end of trial date
    02 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2020
    First version publication date
    19 Jun 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BA058-05-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01674621
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radius Health Inc.
    Sponsor organisation address
    950 Winter Street, Waltham, MA, United States, 02451
    Public contact
    Associate Director, Clinical Operations, Radius Health, Inc., +1 6175514077, ncantacesso@radiuspharm.com
    Scientific contact
    VP, Osteoporosis Clinical Development, Radius Health Inc., +1 617-444-1943, bmitlak@radiuspharm.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall objectives of this study were to determine the clinical safety and efficacy of abaloparatide-transdermal (TD) in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to abaloparatide-TD placebo patch and to select dose levels of abaloparatide-TD for further clinical evaluation.
    Protection of trial subjects
    This study was conducted according to the protocol and in compliance with Good Clinical Practice, the ethical principles stated in the Declaration of Helsinki, and other applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 128
    Country: Number of subjects enrolled
    Estonia: 39
    Country: Number of subjects enrolled
    Poland: 51
    Country: Number of subjects enrolled
    United States: 32
    Worldwide total number of subjects
    250
    EEA total number of subjects
    218
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    74
    From 65 to 84 years
    176
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The actual number of participants per age categories of 18-64 years and 65-84 years is not available. Therefore, estimates for the number of participants in each category is provided in the field labeled "Number of subjects enrolled per age group."

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Data analyst, Assessor
    Blinding implementation details
    Since the abaloparatide injection arm was administered subcutaneously (SC), it was not possible to blind this arm of the study. Therefore, abaloparatide-SC was considered a reference drug, but the centralized BMD assessments and bone marker evaluations remained blinded to all treatment assignments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Abaloparatide Transdermal (50 mcg)
    Arm description
    		 Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abaloparatide Transdermal
    Investigational medicinal product code
    Other name
    BA058 Transdermal
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months

    Arm title
    		 Abaloparatide Transdermal (100 mcg)
    Arm description
    		 Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abaloparatide Transdermal
    Investigational medicinal product code
    Other name
    BA058 Transdermal
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months

    Arm title
    		 Abaloparatide Transdermal (150 mcg)
    Arm description
    		 Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abaloparatide Transdermal
    Investigational medicinal product code
    Other name
    BA058 Transdermal
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months

    Arm title
    		 Abaloparatide Injection (80 mcg)
    Arm description
    		 Abaloparatide-SC Injection - 80 mcg daily injections for up to 6 months
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Abaloparatide Injection
    Investigational medicinal product code
    Other name
    BA058 Injection
    Pharmaceutical forms
    Solution for injection, Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months

    Arm title
    		 Abaloparatide Transdermal Placebo (0 mcg)
    Arm description
    		 Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abaloparatide Transdermal Placebo
    Investigational medicinal product code
    Other name
    BA058 Placebo
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months

    Number of subjects in period 1
    		Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Started
    50
    51
    48
    51
    50
    Modified Intent-to-Treat Population
    47
    46
    43
    49
    46
    Safety Population
    50
    51
    47
    51
    50
    Completed
    45
    43
    41
    45
    44
    Not completed
    5
    8
    7
    6
    6
         Consent withdrawn by subject
    2
    5
    2
    -
    1
         Adverse event, non-fatal
    3
    2
    5
    5
    1
         Severe Abaloparatide-SC Hypersensitivity
    -
    -
    -
    1
    -
         Other than specified
    -
    1
    -
    -
    2
         Inability to Complete Study Procedures
    -
    -
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Abaloparatide Transdermal (50 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Transdermal (100 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Transdermal (150 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Injection (80 mcg)
    Reporting group description
    		 Abaloparatide-SC Injection - 80 mcg daily injections for up to 6 months

    Reporting group title
    Abaloparatide Transdermal Placebo (0 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months

    Reporting group values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg) Total
    Number of subjects
    		 50 51 48 51 50 250
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.6 ± 7.06 65.2 ± 5.36 66.2 ± 5.37 66.3 ± 6.19 66.5 ± 5.47 -
    Gender, Male/Female
    Units:
        Female
    		 50 51 48 51 50 250
        Male
    		 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Abaloparatide Transdermal (50 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Transdermal (100 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Transdermal (150 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Injection (80 mcg)
    Reporting group description
    		 Abaloparatide-SC Injection - 80 mcg daily injections for up to 6 months

    Reporting group title
    Abaloparatide Transdermal Placebo (0 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months

    Primary: Percent Change from Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months

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    End point title
    		 Percent Change from Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
    End point description
    Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
    End point type
    Primary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    47
    46
    43
    49
    46
    Units: Percent change
        arithmetic mean (standard deviation)
    1.87 ± 2.87
    2.33 ± 2.96
    2.95 ± 3.13
    5.80 ± 4.21
    0.04 ± 2.47
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0066 [1]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [1] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0005 [2]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [2] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001 [3]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [3] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.555
         upper limit
    		 -2.305
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.104
         upper limit
    		 -1.837
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.856
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.519
         upper limit
    		 -1.193

    Secondary: Percent Change from Baseline in BMD of Total Hip at 6 Months

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    End point title
    		 Percent Change from Baseline in BMD of Total Hip at 6 Months
    End point description
    Percent change in BMD as specified by DXA scans of the total hip.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    47
    46
    43
    49
    46
    Units: Percent change
        arithmetic mean (standard deviation)
    0.97 ± 1.95
    1.32 ± 1.96
    1.49 ± 1.73
    2.74 ± 3.05
    -0.02 ± 2.39
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0547 [4]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [4] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0056 [5]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [5] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0018 [6]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [6] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.768
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.864
         upper limit
    		 -0.672
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.522
         upper limit
    		 -0.318
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.247
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.368
         upper limit
    		 -0.126

    Secondary: Percent Change from Baseline in BMD of Forearm at 6 Months

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    End point title
    		 Percent Change from Baseline in BMD of Forearm at 6 Months
    End point description
    Percent change in BMD as specified by DXA scans of the forearm.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    47
    46
    43
    49
    46
    Units: Percent change
        arithmetic mean (standard deviation)
    -0.24 ± 2.74
    -0.16 ± 3.71
    0.84 ± 2.96
    0.33 ± 3.41
    0.05 ± 3.18
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9493 [7]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [7] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9806 [8]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [8] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5191 [9]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [9] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.564
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.168
         upper limit
    		 1.04
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.483
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.115
         upper limit
    		 1.15
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.517
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.106
         upper limit
    		 2.139

    Secondary: Percent Change from Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months

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    End point title
    		 Percent Change from Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    47
    46
    43
    49
    46
    Units: Percent change
        arithmetic mean (standard deviation)
    -4.84 ± 23.87
    5.22 ± 43.66
    -5.52 ± 37.86
    17.30 ± 42.76
    10.23 ± 64.93
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2549 [10]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [10] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9115 [11]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [11] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.239 [12]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [12] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -22.146
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.501
         upper limit
    		 -3.79
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.086
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.543
         upper limit
    		 6.372
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -22.828
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.614
         upper limit
    		 -4.041

    Secondary: Percent Change from Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months

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    End point title
    		 Percent Change from Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    47
    46
    43
    49
    46
    Units: Percent change
        arithmetic mean (standard deviation)
    -17.26 ± 22.86
    -8.42 ± 29.51
    -16.63 ± 25.11
    10.28 ± 72.31
    -6.76 ± 31.35
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1632 [13]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [13] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Placebo
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9834 [14]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [14] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2179 [15]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [15] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -27.541
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48.557
         upper limit
    		 -6.525
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -18.702
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.835
         upper limit
    		 2.43
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -26.914
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48.424
         upper limit
    		 -5.405

    Secondary: Percent Change from Baseline in Serum Osteocalcin at 6 Months

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    End point title
    		 Percent Change from Baseline in Serum Osteocalcin at 6 Months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    47
    46
    43
    49
    46
    Units: Percent change
        arithmetic mean (standard deviation)
    -4.37 ± 19.36
    6.67 ± 33.38
    -3.83 ± 22.01
    69.54 ± 81.79
    -4.21 ± 27.55
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1 [16]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [16] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.12 [17]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [17] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9998 [18]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [18] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -73.906
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -96.926
         upper limit
    		 -50.886
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -62.872
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -86.019
         upper limit
    		 -39.725
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -73.367
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -96.927
         upper limit
    		 -49.807

    Secondary: Percent Change from Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months

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    End point title
    		 Percent Change from Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    47
    46
    43
    49
    46
    Units: Percent change
        arithmetic mean (standard deviation)
    -12.76 ± 26.81
    1.52 ± 57.29
    -6.78 ± 38.91
    97.64 ± 172.52
    -7.26 ± 35.49
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8569 [19]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [19] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6091 [20]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [20] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9999 [21]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [21] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -110.398
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -156.966
         upper limit
    		 -63.831
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -96.115
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -142.94
         upper limit
    		 -49.29
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -104.418
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -152.079
         upper limit
    		 -56.758

    Secondary: Percent Change from Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months

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    End point title
    		 Percent Change from Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    47
    46
    43
    49
    46
    Units: Percent change
        arithmetic mean (standard deviation)
    -2.61 ± 28.77
    1.65 ± 48.66
    -8.22 ± 54.84
    41.11 ± 104.12
    9.42 ± 22.57
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3483 [22]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [22] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6839 [23]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [23] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) versus Placebo
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1067 [24]
    Method
    		 Dunnett's test
    Confidence interval
    Notes
    [24] - Threshold for significance at 0.05 level.
    Statistical analysis title
    		 Abaloparatide Transdermal (50 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (50 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -43.721
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -75.748
         upper limit
    		 -11.694
    Statistical analysis title
    		 Abaloparatide Transdermal (100 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (100 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -39.461
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -71.665
         upper limit
    		 -7.257
    Statistical analysis title
    		 Abaloparatide Transdermal (150 mcg) vs Injection
    Comparison groups
    Abaloparatide Transdermal (150 mcg) v Abaloparatide Injection (80 mcg)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -49.334
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -82.113
         upper limit
    		 -16.555

    Secondary: Number of Participants with Abnormal Physical Examinations at Screening and End of Treatment (6 Months)

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    End point title
    		 Number of Participants with Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
    End point description
    A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.
    End point type
    Secondary
    End point timeframe
    Baseline up to 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    50
    51
    47
    51
    50
    Units: participants
        General appearance at Screening
    0
    0
    0
    1
    0
        General appearance at 6 months
    0
    0
    1
    1
    0
        Skin at Screening
    28
    24
    17
    14
    21
        Skin at 6 months
    29
    26
    16
    14
    17
        Head at Screening
    6
    3
    2
    5
    1
        Head at 6 months
    6
    4
    3
    4
    2
        Lungs at Screening
    0
    0
    0
    1
    1
        Lungs at 6 months
    0
    0
    0
    1
    0
        Breasts at Screening
    4
    7
    3
    3
    11
        Breasts at 6 months
    4
    7
    3
    4
    10
        Abdomen at Screening
    7
    8
    4
    9
    4
        Abdomen at 6 months
    6
    7
    3
    9
    3
        Lymph nodes at Screening
    0
    0
    1
    0
    0
        Lymph nodes at 6 months
    0
    0
    0
    0
    1
        Columna at Screening
    1
    3
    7
    4
    1
        Columna at 6 months
    1
    2
    7
    3
    1
        Extremities at Screening
    21
    13
    14
    23
    21
        Extremities at 6 months
    23
    10
    14
    25
    21
        Neurologic at Screening
    0
    0
    0
    2
    1
        Neurologic at 6 months
    0
    0
    0
    3
    1
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs) that Occurred During the Study That were Associated with Vital Sign Changes

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events (TEAEs) that Occurred During the Study That were Associated with Vital Sign Changes
    End point description
    Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
    End point type
    Secondary
    End point timeframe
    Baseline up to 7 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    50
    51
    47
    51
    50
    Units: participants
        Hypertension
    0
    1
    0
    0
    0
        Blood Pressure Increased
    0
    0
    1
    1
    0
        Heart Rate increased
    0
    0
    1
    0
    0
        Dyspnoea
    0
    0
    0
    1
    0
        Dizziness
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result

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    End point title
    		 Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
    End point description
    The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
    End point type
    Secondary
    End point timeframe
    Baseline up to 7 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    50
    51
    47
    51
    50
    Units: participants
    0
    0
    1
    2
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with an Abnormal Clinical Hematology Laboratory Parameter with an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4

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    End point title
    		 Number of Participants with an Abnormal Clinical Hematology Laboratory Parameter with an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
    End point description
    Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 <1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: <25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0–4.9 mmol/L; Grade 4: <65.0 g/L or <4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, > 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
    End point type
    Secondary
    End point timeframe
    Baseline up to 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    50
    51
    47
    51
    50
    Units: participants
    6
    5
    4
    1
    5
    No statistical analyses for this end point

    Secondary: Number of Participants with an Abnormal Clinical Chemistry Laboratory Parameter with an ECOG Score of Grade 3 or Grade 4

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    End point title
    		 Number of Participants with an Abnormal Clinical Chemistry Laboratory Parameter with an ECOG Score of Grade 3 or Grade 4
    End point description
    Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), >1.0 g%, or >10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: >6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: >20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: >3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
    End point type
    Secondary
    End point timeframe
    Baseline up to 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    50
    51
    47
    51
    50
    Units: participants
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with an Abnormal Clinical Coagulation Laboratory Parameter with an ECOG Score of Grade 3 or Grade 4

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    End point title
    		 Number of Participants with an Abnormal Clinical Coagulation Laboratory Parameter with an ECOG Score of Grade 3 or Grade 4
    End point description
    Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: >2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: >3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
    End point type
    Secondary
    End point timeframe
    Baseline up to 6 Months
    End point values
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Number of subjects analysed
    50
    51
    47
    51
    50
    Units: participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 7 Months
    Adverse event reporting additional description
    Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. Individual number of occurrences (events) are not available for this study. Therefore, the number of participants exposed per preferred term are reported in the field of the number of occurrences (events).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Abaloparatide Transdermal (50 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Transdermal (100 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Transdermal (150 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months

    Reporting group title
    Abaloparatide Injection (80 mcg)
    Reporting group description
    		 Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months

    Reporting group title
    Abaloparatide Transdermal Placebo (0 mcg)
    Reporting group description
    		 Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months

    Serious adverse events
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 51 (3.92%)
    2 / 47 (4.26%)
    4 / 51 (7.84%)
    1 / 50 (2.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 47 (2.13%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 50 (80.00%)
    40 / 51 (78.43%)
    37 / 47 (78.72%)
    41 / 51 (80.39%)
    39 / 50 (78.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 51 (3.92%)
    0 / 47 (0.00%)
    3 / 51 (5.88%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    3
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 51 (3.92%)
    3 / 47 (6.38%)
    8 / 51 (15.69%)
    1 / 50 (2.00%)
         occurrences all number
    2
    2
    3
    8
    1
    Headache
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 51 (3.92%)
    5 / 47 (10.64%)
    5 / 51 (9.80%)
    5 / 50 (10.00%)
         occurrences all number
    2
    2
    5
    5
    5
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    4 / 50 (8.00%)
    5 / 51 (9.80%)
    4 / 47 (8.51%)
    0 / 51 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    4
    5
    4
    0
    2
    Application site pruritus
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    4 / 47 (8.51%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    4
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 51 (5.88%)
    1 / 47 (2.13%)
    1 / 51 (1.96%)
    2 / 50 (4.00%)
         occurrences all number
    1
    3
    1
    1
    2
    Injection site erythema
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 47 (0.00%)
    3 / 51 (5.88%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 51 (0.00%)
    3 / 47 (6.38%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    4
    0
    3
    1
    0
    Nausea
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 51 (5.88%)
    6 / 47 (12.77%)
    3 / 51 (5.88%)
    2 / 50 (4.00%)
         occurrences all number
    2
    3
    6
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 51 (1.96%)
    3 / 47 (6.38%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    3
    1
    3
    0
    1
    Renal and urinary disorders
    Hypercalciuria
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    2 / 47 (4.26%)
    3 / 51 (5.88%)
    3 / 50 (6.00%)
         occurrences all number
    0
    1
    2
    3
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    4 / 47 (8.51%)
    3 / 51 (5.88%)
    3 / 50 (6.00%)
         occurrences all number
    1
    0
    4
    3
    3
    Back pain
         subjects affected / exposed
    1 / 50 (2.00%)
    4 / 51 (7.84%)
    3 / 47 (6.38%)
    3 / 51 (5.88%)
    5 / 50 (10.00%)
         occurrences all number
    1
    4
    3
    3
    5
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    4 / 47 (8.51%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    4
    1
    1
    Cystitis
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    4 / 47 (8.51%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
         occurrences all number
    2
    0
    4
    1
    1
    Influenza
         subjects affected / exposed
    4 / 50 (8.00%)
    4 / 51 (7.84%)
    2 / 47 (4.26%)
    5 / 51 (9.80%)
    4 / 50 (8.00%)
         occurrences all number
    4
    4
    2
    5
    4
    Nasopharyngitis
         subjects affected / exposed
    11 / 50 (22.00%)
    10 / 51 (19.61%)
    8 / 47 (17.02%)
    13 / 51 (25.49%)
    9 / 50 (18.00%)
         occurrences all number
    11
    10
    8
    13
    9
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 47 (0.00%)
    3 / 51 (5.88%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    3
    1
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 51 (5.88%)
    1 / 47 (2.13%)
    1 / 51 (1.96%)
    2 / 50 (4.00%)
         occurrences all number
    3
    3
    1
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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