Status:
COMPLETED
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
Lead Sponsor:
Amgen
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- Participants who experienced myocardial infarction or stroke within a year prior to entering this study.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06079476
Start Date
October 30 2023
End Date
October 18 2025
Last Update
November 3 2025
Active Locations (10)
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1
Stavya Spine Hospital and Research Institute SSHRI
Ahmedabad, Gujarat, India, 380 007
2
MS Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India, 560054
3
King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College
Mumbai, Maharashtra, India, 400012
4
Sancheti Institute for Orthopedics and rehabilitation
Pune, Maharashtra, India, 411005