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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Calcium; Etidronic Acid; Risedronate Sodium; Risedronic Acid; Teriparatide; Vitamin D

Criteria

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