Study Complete
Sponsor ID
20210025
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India with Osteoporosis at a High Risk of Fracture.
Study Details
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.
Protocol Summary
Primary Outcome Measures
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
Timeframe: Up to 12 months
Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE)
Timeframe: Up to 12 months
Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments
Timeframe: Baseline, Month 12
Number of Participants With Clinically Significant Changes in Vital Signs
Timeframe: Baseline, Month 12
Secondary Outcome Measures
Percentage Change From Baseline in Bone Mineral Density (BMD) (Measured by Dual-energy X-ray Absorptiometry [DXA]) of the Lumbar Spine
Timeframe: At 6 months and 12 months
Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip
Timeframe: At 6 months and 12 months
Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck
Timeframe: At 6 months and 12 months
Locations
Location
King Georges Medical University
Lucknow, Uttar Pradesh, India, 226 003
Status
Recruiting
Location
Stavya Spine Hospital and Research Institute SSHRI
Ahmedabad, Gujarat, India, 380 007
Status
Recruiting
Location
MGM Healthcare
Chennai, Tamil Nadu, India, 600 029
Status
Recruiting
Location
Sancheti Institute for Orthopedics and rehabilitation
Pune, Maharashtra, India, 411005
Status
Recruiting
Location
Apollo Hospital
New Delhi, Delhi, India, 110076
Status
Recruiting
Location
King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College
Mumbai, Maharashtra, India, 400012
Status
Recruiting
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