Postmenopausal Osteoporosis Clinical Trial
Official title:
An Open-label, Single-arm, Multicenter Phase 4 Study to Evaluate Safety and Tolerability of Romosozumab (EVENITY® ) in Postmenopausal Women in India With Osteoporosis and a High Risk of Fracture.
| Verified date | April 2024 |
| Source | Amgen |
| Contact | Amgen Call Center |
| Phone | 866-572-6436 |
| medinfo[@]amgen.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | November 1, 2025 |
| Est. primary completion date | November 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Participants diagnosed with osteoporosis who are postmenopausal and have a high risk of fracture who provided inform consent (in-person or through their legally authorized representative) to participate in the use of romosozumab per local label in India. Exclusion Criteria: - Participants who experienced myocardial infarction or stroke within a year prior to entering this study. |
| Country | Name | City | State |
|---|---|---|---|
| India | Stavya Spine Hospital and Research Institute SSHRI | Ahmedabad | Gujarat |
| India | MS Ramaiah Medical College and Hospitals | Bangalore | Karnataka |
| India | Post Graduate Institute of Medical Education and Research | Chandigarh | Punjab |
| India | MGM Healthcare | Chennai | Tamil Nadu |
| India | King Georges Medical University | Lucknow | Uttar Pradesh |
| India | King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College | Mumbai | Maharashtra |
| India | Apollo Hospital | New Delhi | Delhi |
| India | Sir Ganga Ram Hospital | New Delhi | Delhi |
| India | Sancheti Institute for Orthopedics and rehabilitation | Pune | Maharashtra |
| India | Christain Medical College | Vellore | Tamil Nadu |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Up to 12 months | ||
| Primary | Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE) | Up to 12 months | ||
| Primary | Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments | Baseline, Month 12 | ||
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs | Baseline, Month 12 | ||
| Secondary | 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 | ||
| Secondary | Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip | At 6 months and 12 months | ||
| Secondary | Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck | At 6 months and 12 months |
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