A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
- Registration Number
- NCT06079476
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- 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.
- Participants who experienced myocardial infarction or stroke within a year prior to entering this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 4: Romosozumab Romosozumab Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months.
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip At 6 months and 12 months 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 Femoral Neck At 6 months and 12 months
Trial Locations
- Locations (10)
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Apollo Hospital
🇮🇳New Delhi, Delhi, India
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
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