Back to resultsA Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
Primary Purpose
Postmenopausal Osteoporosis
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Romosozumab
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Romosozumab, EVENITY®, Osteoporosis, Women Health
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phase 4: Romosozumab
Arm Description
Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months.
Outcomes
Primary Outcome Measures
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE)
Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments
Number of Participants With Clinically Significant Changes in Vital Signs
Secondary Outcome Measures
Percentage Change From Baseline in Bone Mineral Density (BMD) (Measured by Dual-energy X-ray Absorptiometry [DXA]) of the Lumbar Spine
Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip
Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06079476
Brief Title
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 13, 2023 (Anticipated)
Primary Completion Date
March 5, 2026 (Anticipated)
Study Completion Date
March 5, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Romosozumab, EVENITY®, Osteoporosis, Women Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase 4: Romosozumab
Arm Type
Experimental
Arm Description
Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months.
Intervention Type
Drug
Intervention Name(s)
Romosozumab
Intervention Description
Single-use prefilled syringe for SC injection.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
Time Frame
Up to 12 months
Title
Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE)
Time Frame
Up to 12 months
Title
Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments
Time Frame
Baseline, Month 12
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
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
Title
Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip
Time Frame
At 6 months and 12 months
Title
Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck
Time Frame
At 6 months and 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
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