NCT06079476

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2025

Completed
Last Updated

November 3, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

September 25, 2023

Last Update Submit

October 30, 2025

Conditions

Postmenopausal Osteoporosis

Keywords

RomosozumabEVENITY®OsteoporosisWomen Health

Outcome Measures

Primary Outcomes (4)

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

    Up to 12 months

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

    Up to 12 months

  • Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments

    Baseline, Month 12

  • Number of Participants With Clinically Significant Changes in Vital Signs

    Baseline, Month 12

Secondary Outcomes (3)

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

    At 6 months and 12 months

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

    At 6 months and 12 months

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

    At 6 months and 12 months

Study Arms (1)

Phase 4: Romosozumab

EXPERIMENTAL

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

Drug: Romosozumab

Interventions

RomosozumabDRUG

Single-use prefilled syringe for SC injection.

Phase 4: Romosozumab

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Stavya Spine Hospital and Research Institute SSHRI

Ahmedabad, Gujarat, 380 007, India

Location

MS Ramaiah Medical College and Hospitals

Bangalore, Karnataka, 560054, India

Location

King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College

Mumbai, Maharashtra, 400012, India

Location

Sancheti Institute for Orthopedics and rehabilitation

Pune, Maharashtra, 411005, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Apollo Hospital

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Post Graduate Institute of Medical Education and Research

Chandigarh, Punjab, 160 012, India

Location

MGM Healthcare

Chennai, Tamil Nadu, 600 029, India

Location

Christain Medical College

Vellore, Tamil Nadu, 632004, India

Location

King Georges Medical University

Lucknow, Uttar Pradesh, 226 003, India

Location

Related Links

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 12, 2023

Study Start

October 30, 2023

Primary Completion

October 18, 2025

Study Completion

October 18, 2025

Last Updated

November 3, 2025

Record last verified: 2025-10

Locations

IN(10)