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

Amgen

Status and phase: Active, not recruiting; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Romosozumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06079476

20210025

Details and patient eligibility

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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Phase 4: Romosozumab

Experimental group

Description:

Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months.

Treatment:

Drug: Romosozumab