CompletedPhase 4

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

United States224 participantsStarted 2009-04

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Lumbar Spine Areal Bone Mineral Density (BMD)

Timeframe: Baseline, Week 78

Trial details

NCT IDNCT00887354

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

Results submitted2016-07-15

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