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A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
Sponsor: Amgen
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.
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-10-30
Completion Date
2025-10-18
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Romosozumab
Single-use prefilled syringe for SC injection.
Locations (10)
Stavya Spine Hospital and Research Institute SSHRI
Ahmedabad, Gujarat, India
MS Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College
Mumbai, Maharashtra, India
Sancheti Institute for Orthopedics and rehabilitation
Pune, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Apollo Hospital
New Delhi, National Capital Territory of Delhi, India
Post Graduate Institute of Medical Education and Research
Chandigarh, Punjab, India
MGM Healthcare
Chennai, Tamil Nadu, India
Christain Medical College
Vellore, Tamil Nadu, India
King Georges Medical University
Lucknow, Uttar Pradesh, India