Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Second study on the Effect of Teriparatide on Femoral Neck Fracture Healing

    Summary
    EudraCT number
    		 2011-001116-65
    Trial protocol
    		 HU   BE   GR   PL   NL   DE  
    Global end of trial date
    20 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B3D-MC-GHDQ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01473602
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14125, Trial Alias: B3D-MC-GHDQ
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    20 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the effect of 6 months of treatment with teriparatide 20 microgram (μg)/day versus placebo on the proportion of men and postmenopausal women ≥50 years of age with successful fracture healing 24 months after internal fixation of a low trauma femoral neck fracture
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jan 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Romania: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    39
    EEA total number of subjects
    27
    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)
    9
    From 65 to 84 years
    26
    85 years and over
    4

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 No text entered.

    Pre-assignment
    Screening details
    		 No text entered.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Teriparatide
    Arm description
    		 Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Teriparatide
    Investigational medicinal product code
    Other name
    Forteo, Forsteo, LY333334
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 microgram (µg) administered once daily by SC injection for 6 months

    Investigational medicinal product name
    Calcium supplementation
    Investigational medicinal product code
    Other name
    Dietary Supplement: Calcium supplementation
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The supplement dose for calcium should be up to approximately 1000 milligram (mg)/day elemental calcium starting as soon as possible after screening and continuing through 12 months.

    Investigational medicinal product name
    Vitamin D supplementation
    Investigational medicinal product code
    Other name
    Dietary Supplement: Vitamin D supplementation
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During screening, approximately 1000 International Unit (IU)/day vitamin D. The dose of vitamin D may then be increased at the discretion of the invetigator.

    Arm title
    		 Placebo
    Arm description
    		 Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered once daily by subcutaneous (SC) injection for 6 months

    Investigational medicinal product name
    Calcium supplementation
    Investigational medicinal product code
    Other name
    Dietary Supplement: Calcium supplementation
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All participants will receive supplements of calcium and vitamin D beginning at screening and continuing for 12 months.

    Investigational medicinal product name
    Vitamin D supplementation
    Investigational medicinal product code
    Other name
    Dietary Supplement: Vitamin D supplementation
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All participants will receive supplements of calcium and vitamin D beginning at screening and continuing for 12 months.

    Number of subjects in period 1
    		Teriparatide Placebo
    Started
    18
    21
    Received at Least 1 Dose of Study Drug
    18
    20
    Completed 6 Months
    12
    15
    Completed 12 Months
    10
    13
    Completed
    10
    13
    Not completed
    8
    8
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    5
    4
         Physician decision
    1
    -
         Adverse Event
    1
    2
         Lost to follow-up
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Teriparatide
    Reporting group description
    		 Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.

    Reporting group values
    		 Teriparatide Placebo Total
    Number of subjects
    		 18 21 39
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.39 ( 10.259 ) 69.93 ( 10.417 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 16 30
        Male
    		 4 5 9
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 4 5 9
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 14 15 29
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 1 3
        Not Hispanic or Latino
    		 9 9 18
        Unknown or Not Reported
    		 7 11 18
    Region of Enrollment
    Units: Subjects
        United States
    		 2 1 3
        Hungary
    		 6 8 14
        Belgium
    		 2 2 4
        Romania
    		 2 3 5
        Netherlands
    		 2 2 4
        Korea, Republic of
    		 4 5 9
    Surgical screw type
    Surgical screws used in initial surgery to repair femur neck hip fracture.
    Units: Subjects
        Cancellous Screws
    		 18 18 36
        Sliding Hip Screws
    		 0 2 2
        Not Recorded
    		 0 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Teriparatide
    Reporting group description
    		 Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.

    Primary: Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture

    		 Close Top of page
    End point title
    		 Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
    End point description
    Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    18
    20
    Units: Percentage of participants
        number (confidence interval 90%)
    74 (51 to 88)
    93 (70 to 99)
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 1
    Comparison groups
    Teriparatide v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.743 [1]
    Method
    		 K-M with Greenwood SE
    Parameter type
    		 Difference in proportion
    Point estimate
    -0.04
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 -0.14
         upper limit
    		 -
    Notes
    [1] - P-value is based on Z test statistic with Greenwood estimator for standard errors (SE) to compare two Kaplan-Meier (K-M) estimates at 12 month.

    Secondary: Percentage of Participants With Radiographic Evidence of Healing

    		 Close Top of page
    End point title
    		 Percentage of Participants With Radiographic Evidence of Healing
    End point description
    The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing. Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    Randomization, 12 months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    18
    20
    Units: Percentage of participants
    56
    65
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Pain Control During Ambulation

    		 Close Top of page
    End point title
    		 Percentage of Participants With Pain Control During Ambulation
    End point description
    The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    10
    13
    Units: Percentage of participants
    90
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit

    		 Close Top of page
    End point title
    		 Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
    End point description
    The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    11
    14
    Units: Percentage of participants
    82
    93
    No statistical analyses for this end point

    Secondary: Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing

    		 Close Top of page
    End point title
    		 Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
    End point description
    The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    11
    13
    Units: Percentage of participants
    91
    85
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Functional Evidence of Healing

    		 Close Top of page
    End point title
    		 Percentage of Participants With Functional Evidence of Healing
    End point description
    Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant’s gait speed in m/s. Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    13
    15
    Units: Percentage of participants
    77
    67
    No statistical analyses for this end point

    Secondary: Percentage of Participants Able to Ambulate

    		 Close Top of page
    End point title
    		 Percentage of Participants Able to Ambulate
    End point description
    Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    13
    15
    Units: Percentage of participants
    77
    93
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Regained Their Prefracture Ambulatory Status

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Regained Their Prefracture Ambulatory Status
    End point description
    Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) *100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    13
    15
    Units: Percentage of participants
    47
    63
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain

    		 Close Top of page
    End point title
    		 Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
    End point description
    The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    18
    20
    Units: Units on a scale
    least squares mean (standard error)
        During ambulation ( n= 10, 13)
    -1.6 ( 1.46 )
    -1.3 ( 1.45 )
        During 24 hours preceding visit (n= 10, 14)
    -1.2 ( 1.27 )
    -1.4 ( 1.21 )
        On weight bearing (n= 10, 13)
    -2 ( 1.5 )
    -1.4 ( 1.45 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months in Gait Speed

    		 Close Top of page
    End point title
    		 Mean Change From Baseline to 6 Months in Gait Speed
    End point description
    The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant’s gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    10
    13
    Units: m/s
        least squares mean (standard error)
    0.168 ( 0.153 )
    0.118 ( 0.145 )
    No statistical analyses for this end point

    Secondary: Time to Revision Surgery

    		 Close Top of page
    End point title
    		 Time to Revision Surgery
    End point description
    Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.
    End point type
    Secondary
    End point timeframe
    Baseline, Revision Surgery
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    18
    20
    Units: Days
        median (full range (min-max))
    333.5 (35 to 443)
    361 (29 to 426)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores

    		 Close Top of page
    End point title
    		 Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
    End point description
    SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    18
    20
    Units: Units on a scale
    least squares mean (standard error)
        PCS Month 6 (n=12, 14)
    0.89 ( 3 )
    1.78 ( 2.75 )
        MCS Month 6 (n=12, 14)
    -8.84 ( 5.8 )
    -10.71 ( 5.14 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)

    		 Close Top of page
    End point title
    		 Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
    End point description
    WOMAC: was a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    18
    20
    Units: Units on a scale
    least squares mean (standard error)
        Physical Function Score - Month 6 (n=11, 12)
    10.5 ( 12.41 )
    1.1 ( 12.42 )
        Pain Score - Month 6 (n=12, 13)
    10.6 ( 10.64 )
    13.6 ( 10.09 )
        Stiffness Score - Month 6 (n=12, 15)
    13.5 ( 8.71 )
    16.9 ( 7.74 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score

    		 Close Top of page
    End point title
    		 Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score
    End point description
    The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    		 Teriparatide Placebo
    Number of subjects analysed
    18
    20
    Units: Units on a scale
        least squares mean (standard error)
    13 ( 6.42 )
    10.4 ( 6.67 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    B3D-MC-GHDQ
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Screening
    Reporting group description
    		 -

    Reporting group title
    Placebo Acute
    Reporting group description
    		 -

    Reporting group title
    Teriparatide 20 mcg Acute
    Reporting group description
    		 -

    Reporting group title
    Placebo Follow-up
    Reporting group description
    		 -

    Reporting group title
    Teriparatide 20 mcg Follow-up
    Reporting group description
    		 -

    Serious adverse events
    		 Screening Placebo Acute Teriparatide 20 mcg Acute Placebo Follow-up Teriparatide 20 mcg Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 20 (10.00%)
    1 / 18 (5.56%)
    2 / 15 (13.33%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Investigations
    blood glucose fluctuation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
    0 / 12 (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
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (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
    femur fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (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
    acute myocardial infarction
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (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
    myocardial infarction
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (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 / 1
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    hyperventilation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    erythema multiforme
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bronchopneumonia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         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
    osteomyelitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (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
    Metabolism and nutrition disorders
    hyperglycaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         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
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Screening Placebo Acute Teriparatide 20 mcg Acute Placebo Follow-up Teriparatide 20 mcg Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 39 (12.82%)
    5 / 20 (25.00%)
    3 / 18 (16.67%)
    4 / 15 (26.67%)
    3 / 12 (25.00%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    hypotension
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    orthostatic hypotension
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Surgical and medical procedures
    bladder catheterisation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    coronary arterial stent insertion
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    removal of internal fixation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    wisdom teeth removal
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    wrist surgery
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    pulmonary embolism
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    sleep disorder
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Investigations
    blood cholesterol increased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    bone density decreased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    lethargy
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    multiple system atrophy
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    parkinsonism
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    sciatica
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    vascular dementia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    hyperchlorhydria
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    nausea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    toothache
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    vomiting
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    rash
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    skin necrosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    0
    1
    fracture pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    osteopenia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    pain in extremity
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 18 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infections and infestations
    pharyngitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed [1]
    0 / 30 (0.00%)
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    hyperlipidaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2012
    The sponsor decided to end enrolment prematurely. The decision to stop enrolment was due to operational challenges and enrolment feasibility with regard to completing the study in a timely manner and not based on any safety or efficacy concerns in the trial. All active patients who were enrolled were offered to continue, and complete the study to 12 months.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 16:22:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA