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

Last updated: November 14, 2024
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

4

Condition

Post-menopausal Osteopenia

Osteoporosis

Treatment

Romosozumab

Clinical Study ID

NCT06079476
20210025
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosed with osteoporosis who are postmenopausal and have a high riskof fracture who provided inform consent (in-person or through their legallyauthorized representative) to participate in the use of romosozumab per local labelin India.

Exclusion

Exclusion Criteria:

  • Participants who experienced myocardial infarction or stroke within a year prior toentering this study.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Romosozumab
Phase: 4
Study Start date:
October 30, 2023
Estimated Completion Date:
October 21, 2025

Connect with a study center

  • Apollo Hospital

    New Delhi, Delhi 110076
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    New Delhi, Delhi 110060
    India

    Site Not Available

  • Stavya Spine Hospital and Research Institute SSHRI

    Ahmedabad, Gujarat 380 007
    India

    Site Not Available

  • MS Ramaiah Medical College and Hospitals

    Bangalore, Karnataka 560054
    India

    Site Not Available

  • King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College

    Mumbai, Maharashtra 400012
    India

    Site Not Available

  • Sancheti Institute for Orthopedics and rehabilitation

    Pune, Maharashtra 411005
    India

    Site Not Available

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, Punjab 160 012
    India

    Site Not Available

  • MGM Healthcare

    Chennai, Tamil Nadu 600 029
    India

    Site Not Available

  • Christain Medical College

    Vellore, Tamil Nadu 632004
    India

    Site Not Available

  • King Georges Medical University

    Lucknow, Uttar Pradesh 226 003
    India

    Site Not Available

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