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New osteoporosis drug safety checked in indian women

NCT ID NCT06079476

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the safety of romosozumab (Evenity) in 100 postmenopausal women in India who have osteoporosis and a high risk of bone fractures. Researchers tracked side effects, serious events, and changes in lab tests and vital signs. They also measured bone density changes in the spine and hip. The goal was to see if the drug is safe and tolerable for this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Romosozumab (Evenity)
What this could lead to
If successful, this could confirm that romosozumab is a safe option for treating osteoporosis and reducing fracture risk in postmenopausal women in India.
What could go wrong
This is a small, completed Phase 4 safety study, not designed to prove effectiveness. Results may not apply to other populations, and rare side effects may not be detected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

100 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteoporosis postmenopausal osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postmenopausal osteoporosis

Contacts and locations

Locations

  • Apollo Hospital

    New Delhi, National Capital Territory of Delhi, 110076, India

  • Christain Medical College

    Vellore, Tamil Nadu, 632004, India

  • King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College

    Mumbai, Maharashtra, 400012, India

  • King Georges Medical University

    Lucknow, Uttar Pradesh, 226 003, India

  • MGM Healthcare

    Chennai, Tamil Nadu, 600 029, India

  • MS Ramaiah Medical College and Hospitals

    Bangalore, Karnataka, 560054, India

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, Punjab, 160 012, India

  • Sancheti Institute for Orthopedics and rehabilitation

    Pune, Maharashtra, 411005, India

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Stavya Spine Hospital and Research Institute SSHRI

    Ahmedabad, Gujarat, 380 007, India

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