Clinical trial NCT06079476: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Keywords: Romosozumab
EVENITY®
Osteoporosis
Women Health
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
timeFrame: Up to 12 months
measure: Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE)
timeFrame: Up to 12 months
measure: Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments
timeFrame: Baseline, Month 12
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percentage Change From Baseline in Bone Mineral Density (BMD) (Measured by Dual-energy X-ray Absorptiometry [DXA]) of the Lumbar Spine
timeFrame: At 6 months and 12 months
measure: Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip
timeFrame: At 6 months and 12 months
measure: Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck
timeFrame: At 6 months and 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: New Delhi
country: India
facility: Apollo Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Stavya Spine Hospital and Research Institute SSHRI
state: Gujarat
city: Bangalore
country: India
facility: MS Ramaiah Medical College and Hospitals
state: Karnataka
city: Mumbai
country: India
facility: King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College
state: Maharashtra
city: Pune
country: India
facility: Sancheti Institute for Orthopedics and rehabilitation
state: Maharashtra
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
state: Punjab
city: Chennai
country: India
facility: MGM Healthcare
state: Tamil Nadu
city: Vellore
country: India
facility: Christain Medical College
state: Tamil Nadu
city: Lucknow
country: India
facility: King Georges Medical University
state: Uttar Pradesh
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: