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The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 4: Romosozumab | Experimental | Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romosozumab | Drug | Single-use prefilled syringe for SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Up to 12 months | |
| Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE) | Up to 12 months | |
| Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments | Baseline, Month 12 | |
| Number of Participants With Clinically Significant Changes in Vital Signs | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Bone Mineral Density (BMD) (Measured by Dual-energy X-ray Absorptiometry [DXA]) of the Lumbar Spine | At 6 months and 12 months | |
| Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip | At 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavya Spine Hospital and Research Institute SSHRI | Ahmedabad | Gujarat | 380 007 | India | ||
| MS Ramaiah Medical College and Hospitals |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C557282 | romosozumab |
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| Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck | At 6 months and 12 months |
| Bangalore |
| Karnataka |
| 560054 |
| India |
| King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College | Mumbai | Maharashtra | 400012 | India |
| Sancheti Institute for Orthopedics and rehabilitation | Pune | Maharashtra | 411005 | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Apollo Hospital | New Delhi | National Capital Territory of Delhi | 110076 | India |
| Post Graduate Institute of Medical Education and Research | Chandigarh | Punjab | 160 012 | India |
| MGM Healthcare | Chennai | Tamil Nadu | 600 029 | India |
| Christain Medical College | Vellore | Tamil Nadu | 632004 | India |
| King Georges Medical University | Lucknow | Uttar Pradesh | 226 003 | India |
| D009750 |
| Nutritional and Metabolic Diseases |