Postmenopausal OsteoporosisPhase 4NCT06079476

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

A Phase 4 study testing Romosozumab in people with Postmenopausal Osteoporosis, run by Amgen at 10 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Postmenopausal Osteoporosis
What is being tested?: Romosozumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 10 sitesIndia
Study dates: 30 Oct 2023to 18 Oct 2025
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

India10 sites

Stavya Spine Hospital and Research Institute SSHRI
Ahmedabad, Gujarat, 380 007
MS Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560054
Post Graduate Institute of Medical Education and Research
Chandigarh, Punjab, 160 012
MGM Healthcare
Chennai, Tamil Nadu, 600 029
King Georges Medical University
Lucknow, Uttar Pradesh, 226 003
King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College
Mumbai, Maharashtra, 400012
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Apollo Hospital
New Delhi, National Capital Territory of Delhi, 110076
Sancheti Institute for Orthopedics and rehabilitation
Pune, Maharashtra, 411005
Christain Medical College
Vellore, Tamil Nadu, 632004

Other trials in India

About this study

Official 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.

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.

Conditions: Postmenopausal Osteoporosis
Being tested: Romosozumab
Keywords: Romosozumab, EVENITY®, Osteoporosis, Women Health
Medical subject headings: Osteoporosis, Postmenopausal, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RomosozumabDrug
Single-use prefilled syringe for SC injection.

Study groups in NCT06079476
Study group	Role	What they receive
Phase 4: Romosozumab	Experimental	Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months. Receives: Drug: Romosozumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial intervention. If an AE occurred on or after the first dose of trial intervention, the AE was considered to be a TEAE.
Measured: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)
An SAE was defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. A TESAE was defined as an SAE that occurred on or after the first dose of trial intervention.
Measured: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months
Number of Participants Who Experienced Clinically Significant Changes in Laboratory Assessments
Laboratory parameters included: hematology (red blood cell, hemoglobin, platelets, white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (sodium, potassium, chloride, bicarbonate, total protein, albumin, calcium, albumin-adjusted calcium, magnesium, phosphorus, glucose, blood urea nitrogen or urea, creatinine, total bilirubin, direct bilirubin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase) and serum 25-hydroxy vitamin D. Clinical significance of laboratory parameters was determined by the investigator.
Measured: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months
Number of Participants Who Experienced Clinically Significant Changes in Vital Signs
Vital signs included: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and temperature. Clinical significance of vital signs was determined by the investigator.
Measured: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months

Secondary outcomes (3)

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6 and Month 12
Lumbar spine BMD was determined by dual-energy X-ray absorptiometry (DXA). Baseline was defined as last evaluation prior to or on Study Day 1. If results from baseline DXA were not available, the results from scans taken on or before Study Day 14 were considered as baseline values.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Total Hip BMD at Month 6 and Month 12
Total hip BMD was determined by DXA. Baseline was defined as last evaluation prior to or on Study Day 1. If results from baseline DXA were not available, the results from scans taken on or before Study Day 14 were considered as baseline values.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Femoral Neck BMD at Month 6 and Month 12
Femoral neck BMD was determined by DXA. Baseline was defined as last evaluation prior to or on Study Day 1. If results from baseline DXA were not available, the results from scans taken on or before Study Day 14 were considered as baseline values.
Measured: Baseline, Month 6 and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 202318 Oct 2025

First posted12 Oct 2023
Study start30 Oct 2023
Primary completion18 Oct 2025
Study completion18 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06079476
Sponsor's protocol ID: 20210025
Status last verified: Sep 2026
First submitted: 25 Sep 2023
Last updated: 21 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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