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.
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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06079476
- Acronym / sponsor ID
- 20210025
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Romosozumab, EVENITY®, Osteoporosis, Women Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 18 Oct 2025 (actual)
- Study completion
- 18 Oct 2025 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Posted 21 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 4: Romosozumab | Experimental | Drug: RomosozumabParticipants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who experienced myocardial infarction or stroke within a year prior to entering this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RomosozumabSingle-use prefilled syringe for SC injection. | Drug | Phase 4: Romosozumab |
Primary outcome
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months
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.
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months
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.
Number of Participants Who Experienced Clinically Significant Changes in Laboratory Assessments
Time frame: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months
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.
Number of Participants Who Experienced Clinically Significant Changes in Vital Signs
Time frame: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months
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.
3 secondary outcomes
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6 and Month 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Total Hip BMD at Month 6 and Month 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Femoral Neck BMD at Month 6 and Month 12
Time frame: Baseline, Month 6 and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Romosozumab in people with Postmenopausal Osteoporosis, run by Amgen at 10 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) (time frame: From first dose of trial intervention to the end of trial; median (min, max) duration was 11.99 (1.02, 13.11) months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.