A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture

Study Overview
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Brief Summary
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This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.

Detailed Description
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The study has 3 periods: a screening phase, a double-blind, double-dummy treatment phase from the time of randomization to the 26 weeks visit, and an open-label treatment phase of approximately 12 month duration, where participants will continue treatment with the same study drug that they were randomized to.

Official Title
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Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide
* Drug: Risedronate
* Drug: Placebo
* Dietary Supplement: Calcium
* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men Exclusion Criteria: Clinically significant abnormal laboratory values History of unresolved skeletal diseases that affect bone metabolism Polytrauma participants and participants with fractures at more than one site

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teriparatide<br>20 micrograms (mcg) a day by subcutaneous injection throughout study. Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only. | Drug: Teriparatide<br>* Administered subcutaneously<br>* Other names: LY333334;Drug: Placebo<br>* Weekly: Administered orally Daily: Administered subcutaneously<br>Dietary Supplement: Calcium<br>* Approximately 500 to 1000 mg/day administered orally throughout study.<br>Dietary Supplement: Vitamin D<br>* Approximately 800 International Units per day (IU/day) administered orally throughout study.<br>|
| Active Comparator: Risedronate<br>35 milligrams (mg) risedronate sodium orally once weekly throughout study. Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only. | Drug: Risedronate<br>* Administered orally<br>Drug: Placebo<br>* Weekly: Administered orally Daily: Administered subcutaneously<br>Dietary Supplement: Calcium<br>* Approximately 500 to 1000 mg/day administered orally throughout study.<br>Dietary Supplement: Vitamin D<br>* Approximately 800 International Units per day (IU/day) administered orally throughout study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lumbar Spine Areal Bone Mineral Density (BMD) | Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No). | Baseline, Week 78 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lumbar Spine Areal Bone Mineral Density | Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No). | Baseline, Week 26; Baseline, Week 52 | 
| Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) . Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use. | Baseline, Week 26; Baseline, Week 52; Baseline, Week 78 | 
| Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No). | Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26 | 
| Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous. | Baseline | 
| Visual Analog Scale (VAS) | Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction. | 6, 12, 18, and 26 Weeks | 
| Timed Up and Go Test | Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score. | 6, 12, 18, and 26 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low bone mass, Recent pertrochanteric hip fracture