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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men with Osteoporosis

    Summary
    EudraCT number
    		 2017-004220-30
    Trial protocol
    		 PL   IT  
    Global end of trial date
    08 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 May 2023
    First version publication date
    24 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BA058-05-019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03512262
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radius Health, Inc.
    Sponsor organisation address
    22 Boston Wharf Road, 7th floor, Boston/MA, United States, 02210
    Public contact
    Radius Contact Information, Radius Health, Inc., 1 6175514000, info@radiuspharm.com
    Scientific contact
    Radius Contact Information, Radius Health, Inc., 1 6175514000, info@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
    14 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide 80 micrograms (mcg) per day administered subcutaneously (SC) compared to placebo in men with osteoporosis. Efficacy was primarily assessed by the change in bone mineral density (BMD) over 12 months.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, the guidelines for current Good Clinical Practice International Conference on Harmonization (ICH), the US Food and Drug Administration Code of Federal Regulations, and all other applicable local regulatory and ethical requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2018
    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
    Poland: 108
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    United States: 101
    Worldwide total number of subjects
    228
    EEA total number of subjects
    109
    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)
    59
    From 65 to 84 years
    168
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants who remained eligible for study participation were randomly allocated, using a 2:1 randomization ratio (abaloparatide:placebo) on Day 1, to receive treatment with either blinded abaloparatide 80 micrograms (mcg) per day or daily placebo subcutaneous (SC) injections.

    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, Assessor
    Blinding implementation details
    Treatment was blinded to participants, investigators, outcome assessor and care provider throughout the study except in a medical emergency where the identity of study medication is necessary for participant treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Abaloparatide
    Arm description
    		 Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abaloparatide
    Investigational medicinal product code
    BA058
    Other name
    TYMLOS®, abaloparatide-SC
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Abaloparatide was administered per dose and schedule specified in the arm description.

    Arm title
    		 Placebo
    Arm description
    		 Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered per dose and schedule specified in the arm description.

    Number of subjects in period 1
    		Abaloparatide Placebo
    Started
    149
    79
    Received at Least 1 Dose of Study Drug
    149
    79
    Completed
    114
    64
    Not completed
    35
    15
         Consent withdrawn by subject
    17
    9
         Adverse event, non-fatal
    8
    3
         Other than Specified
    2
    2
         Lost to follow-up
    7
    1
         Death (non-treatment emergent)
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Abaloparatide
    Reporting group description
    		 Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

    Reporting group values
    		 Abaloparatide Placebo Total
    Number of subjects
    		 149 79 228
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 38 21 59
        From 65-84 years
    		 110 58 168
        85 years and over
    		 1 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.5 ( 8.25 ) 67.8 ( 8.53 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 0 0 0
        Male
    		 149 79 228
    Lumbar Spine Bone Mineral Density (BMD) T-score
    The BMD T-score is the BMD, assessed by dual energy x-ray absorptiometry (DXA), at the site when compared to that of a healthy thirty-year-old. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a man/woman (20 to 29 years old). Lower T-scores indicate worse bone condition.
    Units: BMD T-Score
        arithmetic mean (standard deviation)
    		 -2.11 ( 1.119 ) -2.05 ( 1.217 ) -

    End points

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    End points reporting groups
    Reporting group title
    Abaloparatide
    Reporting group description
    		 Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

    Primary: Percent Change from Baseline in Lumbar Spine BMD at Month 12

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    End point title
    		 Percent Change from Baseline in Lumbar Spine BMD at Month 12
    End point description
    Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    119
    66
    Units: percent change
        least squares mean (standard error)
    8.4820 ( 0.5353 )
    1.1654 ( 0.7235 )
    Statistical analysis title
    		 Percent Change from Baseline in Lumbar Spine BMD
    Statistical analysis description
    Percent change from baseline in lumbar spine BMD at Month 12.
    Comparison groups
    Abaloparatide v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LSM) Means Difference
    Point estimate
    7.3165
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 5.0668
         upper limit
    		 9.5663
    Notes
    [1] - Significance level of 0.01.

    Secondary: Percent Change from Baseline in Total Hip BMD at Month 12

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    End point title
    		 Percent Change from Baseline in Total Hip BMD at Month 12
    End point description
    Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    119
    66
    Units: percent change
        least squares mean (standard error)
    2.1351 ( 0.2711 )
    0.0143 ( 0.3543 )
    Statistical analysis title
    		 Percent Change from Baseline in Total Hip BMD
    Statistical analysis description
    Percent change from baseline in total hip BMD at Month 12.
    Comparison groups
    Abaloparatide v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    2.1209
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 0.9948
         upper limit
    		 3.2469
    Notes
    [2] - Significance level of 0.01.

    Secondary: Percent Change from Baseline in Femoral Neck BMD at Month 12

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    End point title
    		 Percent Change from Baseline in Femoral Neck BMD at Month 12
    End point description
    Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    119
    66
    Units: percent change
        least squares mean (standard error)
    2.9766 ( 0.3448 )
    0.1545 ( 0.4527 )
    Statistical analysis title
    		 Percent Change from Baseline in Femoral Neck BMD
    Statistical analysis description
    Percent change from baseline in femoral neck BMD at Month 12.
    Comparison groups
    Abaloparatide v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    2.8221
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 1.3972
         upper limit
    		 4.2471
    Notes
    [3] - Significance level of 0.01.

    Secondary: Percent Change from Baseline in Lumbar Spine BMD at Month 6

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    End point title
    		 Percent Change from Baseline in Lumbar Spine BMD at Month 6
    End point description
    Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    123
    70
    Units: percent change
        least squares mean (standard error)
    5.5436 ( 0.4127 )
    0.6418 ( 0.5472 )
    No statistical analyses for this end point

    Secondary: Percent Change in Total Hip BMD From Baseline at Month 6

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    End point title
    		 Percent Change in Total Hip BMD From Baseline at Month 6
    End point description
    Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    122
    70
    Units: percent change
        least squares mean (standard error)
    1.3888 ( 0.2142 )
    0.0267 ( 0.2790 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Femoral Neck BMD at Month 6

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    End point title
    		 Percent Change from Baseline in Femoral Neck BMD at Month 6
    End point description
    Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    122
    70
    Units: percent change
        least squares mean (standard error)
    1.4790 ( 0.2714 )
    -0.1884 ( 0.3569 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Ultra-Distal Radius BMD at Month 12

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    End point title
    		 Percent Change from Baseline in Ultra-Distal Radius BMD at Month 12
    End point description
    Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    115
    61
    Units: percent change
        least squares mean (standard error)
    1.4358 ( 0.4236 )
    -0.1915 ( 0.5722 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Distal One-third Radius BMD at Month 12

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    End point title
    		 Percent Change from Baseline in Distal One-third Radius BMD at Month 12
    End point description
    Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    115
    61
    Units: percent change
        least squares mean (standard error)
    -0.0138 ( 0.3253 )
    0.7066 ( 0.4285 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12

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    End point title
    		 Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12
    End point description
    Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    119
    65
    Units: percent change
        arithmetic mean (standard deviation)
    225.919 ( 416.4173 )
    0.291 ( 31.8038 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12

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    End point title
    		 Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12
    End point description
    Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    119
    65
    Units: percent change
        arithmetic mean (standard deviation)
    89.639 ( 206.7227 )
    15.359 ( 40.3351 )
    No statistical analyses for this end point

    Secondary: Number of Participants With New Clinical Fractures

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    End point title
    		 Number of Participants With New Clinical Fractures
    End point description
    Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit).
    End point type
    Secondary
    End point timeframe
    Baseline through Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    149
    79
    Units: participants
        number (not applicable)
    1
    3
    No statistical analyses for this end point

    Secondary: Percent of Participants with Change in Disease Status

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    End point title
    		 Percent of Participants with Change in Disease Status
    End point description
    The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following: 1) Lumbar spine > -2.5 and total hip BMD T-score > -2.5 and < -1.0; 2) Lumbar spine > -2.5 and < -1.0 and total hip BMD T-score > -2.5. Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0.
    End point type
    Secondary
    End point timeframe
    Baseline through Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    142
    75
    Units: percentage of participants
    number (not applicable)
        Osteopenia to Normal
    8.8
    8.0
        Osteopenia to Osteoporosis
    0
    12.0
        Osteoporosis to Normal
    2.9
    0
        Osteoporosis to Osteopenia
    57.1
    12.8
        Normal to Osteopenia or Osteoporosis
    0
    0
    No statistical analyses for this end point

    Secondary: Percent of Participants Experiencing BMD Gains from Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip

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    End point title
    		 Percent of Participants Experiencing BMD Gains from Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip
    End point description
    Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    119
    66
    Units: percentage of participants
    number (not applicable)
        BMD Increase >0% at All Three Sites
    67.2
    15.2
        BMD Increase >3% at All Three Sites
    31.9
    1.5
        BMD Increase >6% at All Three Sites
    9.2
    0.0
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12

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    End point title
    		 Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12
    End point description
    QCT scans were evaluated by a central imaging laboratory. Only 2 participants per reporting group had volumetric BMD measured by QCT at baseline and Month 12, therefore, no data is reported here to maintain participant confidentiality.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: percent change
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [4] - No data is reported here to maintain participant confidentiality (n=2).
    [5] - No data is reported here to maintain participant confidentiality (n=2).
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12

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    End point title
    		 Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12
    End point description
    QCT scans were evaluated by a central imaging laboratory. Only 2 participants per reporting group had volumetric BMD measured by QCT at baseline and Month 12, therefore, no data is reported here to maintain participant confidentiality
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Abaloparatide Placebo
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: percent change
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [6] - No data is reported here to maintain participant confidentiality (n=2).
    [7] - No data is reported here to maintain participant confidentiality (n=2).
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 (after dosing) through Month 13
    Adverse event reporting additional description
    Safety Population was used for analyses of treatment-emergent serious and non-serious adverse events that occurred from Day 1 (after dosing) through Month 13. The one death recorded was due to an event that was not treatment-emergent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

    Reporting group title
    Abaloparatide
    Reporting group description
    		 Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

    Serious adverse events
    		 Placebo Abaloparatide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 79 (5.06%)
    8 / 149 (5.37%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns third degree
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral nerve palsy
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Skin graft rejection
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Abaloparatide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 79 (36.71%)
    73 / 149 (48.99%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 79 (5.06%)
    8 / 149 (5.37%)
         occurrences all number
    4
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 79 (5.06%)
    8 / 149 (5.37%)
         occurrences all number
    5
    8
    Dizziness
         subjects affected / exposed
    1 / 79 (1.27%)
    13 / 149 (8.72%)
         occurrences all number
    1
    19
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    4 / 79 (5.06%)
    19 / 149 (12.75%)
         occurrences all number
    5
    20
    Injection site swelling
         subjects affected / exposed
    0 / 79 (0.00%)
    10 / 149 (6.71%)
         occurrences all number
    0
    10
    Injection site pain
         subjects affected / exposed
    0 / 79 (0.00%)
    9 / 149 (6.04%)
         occurrences all number
    0
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 79 (1.27%)
    10 / 149 (6.71%)
         occurrences all number
    1
    11
    Back pain
         subjects affected / exposed
    5 / 79 (6.33%)
    7 / 149 (4.70%)
         occurrences all number
    5
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 79 (7.59%)
    13 / 149 (8.72%)
         occurrences all number
    7
    14
    Bronchitis
         subjects affected / exposed
    1 / 79 (1.27%)
    8 / 149 (5.37%)
         occurrences all number
    1
    8
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 79 (6.33%)
    7 / 149 (4.70%)
         occurrences all number
    5
    7
    Sinusitis
         subjects affected / exposed
    4 / 79 (5.06%)
    6 / 149 (4.03%)
         occurrences all number
    4
    7

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jan 2018
    • Information added to present data from the referenced studies to support that there is no difference in serum calcium between men and women and that the 4-hour postdose time point will capture the maximum calcium concentration • For the fixed-sequence testing approach employed to control the Type 1 error at the 2-sided significance level for testing the primary and secondary efficacy endpoints, the significance level was changed from 5% to 1%. In addition, minor editorial changes were also made for consistency/clarity and additional details were provided for SAE reporting requirements.
    30 Oct 2018
    • Specified timepoints and endpoints for immunogenicity testing • Added updated PK pharmacokinetics (PK) data • Specified the range of 25-hydroxyvitamin D for inclusion in the study • Changed the timing for retesting of out-of-range laboratory tests • Specified that the exclusion period for participants who have previously received treatment with anabolic steroids or calcineurin inhibitors was within 90 days • Deleted an exclusion criterion that prevented participants from enrolling in the study after receiving anesthesia within 12 weeks.
    06 Jun 2019
    • Changed the BMD criteria from a female reference range to the male reference range.
    10 Dec 2019
    • Allowed for use a historical height measurement in cases where the height of a participant could not be adequately assessed • Allowed for reflex testing for bone-specific alkaline phosphatase if a participant had an elevated alkaline phosphatase at Screening • Allowed for reflex testing for T3 and free T4 if a participant had thyroid stimulating hormone value outside of the normal range at Screening • Allowed DXA scans within 35 days prior to Screening to be used for determining study eligibility • Clarified when a participant's blood pressure and heart rate at Screening must be reviewed by the Sponsor’s Medical Monitor for determining study eligibility
    02 Oct 2020
    • Added sparse PK sampling at the Month 6, 9, and 12 visits In addition, minor editorial changes were also made for consistency/clarity and text was added to clarify that DXA scans were to be performed using a study-approved scanner but could be collected up to 35 days before the participant’s Screening Visit.
    30 Mar 2021
    • Revised the efficacy analysis methods (use of a multiple imputation method, specifically a wash-out imputation approach, to impute missing primary endpoint values, and to add clarifications around study procedures, including COVID-19 details) • Clarified several definitions (osteopenia, lost to follow-up, the Safety and Per Protocol Populations) and updated text regarding antibody analyses to align with the planned analysis methods

    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
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