CompletedPhase 4

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

India100 participantsStarted 2023-10-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT06079476

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-18

View on ClinicalTrials.gov More Postmenopausal Osteoporosis trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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