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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06079476
Other study ID # 20210025
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 30, 2023
Est. completion date November 1, 2025

Study information

Verified date April 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Romosozumab
Single-use prefilled syringe for SC injection.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

India, 

Outcome

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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