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 range18 Years

SexFEMALE

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.

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

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