Study Complete
Sponsor ID
20090153
A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women with Low Bone Mass
Study Details
The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low bone mass.
Protocol Summary
Primary Outcome Measures
Polar cross-sectional moment of inertia at the distal radius assessed by pQCT
Timeframe: Throughout the trial duration (169 days) at screening and on days 29, 57, 85, 127 and 169
Secondary Outcome Measures
Parameters of bone quality (bone mineral content, bone area, bone mineral density, bone circumferences and axial cross-sectional moment of inertia) of the forearm assessed by pQCT
Timeframe: Throughout the trial duration (169 days) at screening and on days 29, 57, 85, 127 and 169
Pharmacokinetic and pharmacodynamic parameters (P1NP, sCTX and BMD of the lumbar spine and forearm by DXA)
Timeframe: Throughout the trial duration (169 days)
Study Documents
Study Synopsis
Available Language(s): English
Locations
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