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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00936897 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postmenopausal Osteoporosis |
Drug: Ibandronate Drug: Denosumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates |
| Estimated Enrollment: | 800 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ibandronate
Ibandronate 150mg PO QM (tablet)
|
Drug: Ibandronate
Ibandronate 150mg PO QM (tablet)
|
|
Experimental: Denosumab
denosumab 60mg Subcutaneous Q6M (pre-filled syringe)
|
Drug: Denosumab
denosumab 60mg SC Q6M (pre-filled syringe)
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
GE Lunar Lumbar spine 0.700 < or = BMD < and = 0.940 Total hip 0.504 < or = BMD < or = 0.756
Hologic Lumbar spine 0.607 < or = BMD < or = 0.827 Total hip 0.454 < or = BMD < or = 0.698 Both the initial and the repeat DXA scan of the lumbar spine OR the total hip must meet the above eligibility criteria.
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00936897 History of Changes |
| Other Study ID Numbers: | 20080562 |
| Study First Received: | July 9, 2009 |
| Last Updated: | January 20, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Central EC, called Comite de Protection des Personnes; Italy: COMITATO ETICO DELL´ENTE OSPEDALIERO OSPEDALI GALLIERA DI GENOVA; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Spain: Comité ético del Hospital Vall d'Hebron; United States: Food and Drug Administration |
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Ibandronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |