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

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Teriparatide; Drug: Risedronate; Drug: Placebo; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D

• Registration Number: NCT00887354
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2016-07-15
• Results First Submitted QC: 2016-11-11
• Results First Posted: 2017-01-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teriparatide	Placebo	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.
Teriparatide	Calcium	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.
Teriparatide	Vitamin D	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.
Risedronate	Placebo	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.
Risedronate	Calcium	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.
Risedronate	Vitamin D	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.
Teriparatide	Teriparatide	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.
Risedronate	Risedronate	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.

Primary Outcome Measures

Name	Time	Method
Change in Lumbar Spine Areal Bone Mineral Density (BMD)	Baseline, Week 78	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).

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	6, 12, 18, and 26 Weeks	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.
Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire	Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26	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).
Change in Lumbar Spine Areal Bone Mineral Density	Baseline, Week 26; Baseline, Week 52	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).
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb	Baseline, Week 26; Baseline, Week 52; Baseline, Week 78	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.
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale	Baseline	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.
Timed "Up and Go" Test	6, 12, 18, and 26 Weeks	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.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇪🇸 Sevilla, Spain