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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2025-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 4: Romosozumab

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

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Single-use prefilled syringe for SC injection.

Interventions

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Romosozumab

Single-use prefilled syringe for SC injection.

Intervention Type DRUG

Eligibility Criteria

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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.