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

Sponsor

Amgen (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06079476

Collaborator

(none)

100

Enrollment

Arm

27.7

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis	Drug: Romosozumab	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Nov 13, 2023

Anticipated Primary Completion Date :

Mar 5, 2026

Anticipated Study Completion Date :

Mar 5, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 4: Romosozumab Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months.	Drug: Romosozumab Single-use prefilled syringe for SC injection.

Arm

Intervention/Treatment

Experimental: Phase 4: Romosozumab

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

Drug: Romosozumab

Single-use prefilled syringe for SC injection.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.