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



Status:Completed
Conditions:Osteoporosis, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:April 2009
End Date:August 2015

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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

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.

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.

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
We found this trial at
7
sites
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Orlando, FL
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Durham, NC
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Fargo, ND
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