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OpenTrials
Completed

NCT Number: NCT06079476

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

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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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Stavya Spine Hospital and Research Institute SSHRI, Ahmedabad, Gujarat, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Romosozumab

Drug

Single-use prefilled syringe for SC injection.

Primary outcomes

  1. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

    Time frame: Up to 12 months

  2. Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE)

    Time frame: Up to 12 months

  3. Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments

    Time frame: Baseline, Month 12

  4. Number of Participants With Clinically Significant Changes in Vital Signs

    Time frame: Baseline, Month 12

Secondary outcomes

  1. Percentage Change From Baseline in Bone Mineral Density (BMD) (Measured by Dual-energy X-ray Absorptiometry [DXA]) of the Lumbar Spine

    Time frame: At 6 months and 12 months

  2. Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip

    Time frame: At 6 months and 12 months

  3. Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck

    Time frame: At 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-label, Single-arm, Multicenter Phase 4 Study to Evaluate Safety and Tolerability of Romosozumab (EVENITY® ) in Postmenopausal Women in India With Osteoporosis and a High Risk of Fracture.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2023
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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