Study Complete
Sponsor ID
20080562
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or Weekly Bisphosphonates
Study Details
This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.
Protocol Summary
Primary Outcome Measures
The primary endpoint is percent change from baseline in BMD at the total hip at 12 months
Timeframe: 12 months
To evaluate safety and tolerability measured by evaluating adverse events, antidenosumab antibodies and laboratory analytes over 12 months
Timeframe: 12 months
Secondary Outcome Measures
To evaluate the effects of transitioning to denosumab 60mg SC Q6M in comparison to transitioning to ibandronate 150mg PO QM on sCTX-1 levels at 1 month (in a subset of subjects).
Timeframe: 12 months
To evaluate the effects of transitioning to denosumab 60mg SC Q6M in comparison to transitioning to ibandronate 150mg PO QM on BMD at the femoral neck at 12 months.
Timeframe: 12 months
To evaluate the effects of transitioning to denosumab 60mg SC Q6M in comparison to transitioning to ibandronate 150mg PO QM on BMD at the lumbar spine at 12 months.
Timeframe: 12 months
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.