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

Sponsored by Amgen

About this trial

Last updated 8 months ago

Study ID

20210025

Status

Active, not recruiting

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

Exclusion Criteria

- Participants who experienced myocardial infarction or stroke within a year prior to entering this study.