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

Sponsor ID
20080562
Clinicaltrials.gov ID
NCT00936897
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
833
Additional Study Details

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.