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

Sponsor ID
20090153
Clinicaltrials.gov ID
NCT00950950
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 785
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
24
Additional Study Details

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

No locations found.