A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.

October 30, 2025 updated by: Amgen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 007
        • Stavya Spine Hospital and Research Institute SSHRI
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • MS Ramaiah Medical College and Hospitals
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College
      • Pune, Maharashtra, India, 411005
        • Sancheti Institute for Orthopedics and rehabilitation
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, National Capital Territory of Delhi, India, 110076
        • Apollo Hospital
    • Punjab
      • Chandigarh, Punjab, India, 160 012
        • Post Graduate Institute of Medical Education and Research
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 029
        • MGM Healthcare
      • Vellore, Tamil Nadu, India, 632004
        • Christain Medical College
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226 003
        • King Georges Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 4: Romosozumab
Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months.
Drug: Romosozumab
Single-use prefilled syringe for SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
Time Frame: Up to 12 months
Up to 12 months
Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE)
Time Frame: Up to 12 months
Up to 12 months
Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments
Time Frame: Baseline, Month 12
Baseline, Month 12
Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: Baseline, Month 12
Baseline, Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage Change From Baseline in Bone Mineral Density (BMD) (Measured by Dual-energy X-ray Absorptiometry [DXA]) of the Lumbar Spine
Time Frame: At 6 months and 12 months
At 6 months and 12 months
Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip
Time Frame: At 6 months and 12 months
At 6 months and 12 months
Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck
Time Frame: At 6 months and 12 months
At 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Actual)

October 18, 2025

Study Completion (Actual)

October 18, 2025

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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