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

Amgen100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Postmenopausal Osteoporosis

Interventions

RomosozumabDRUG

Single-use prefilled syringe for SC injection.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Stavya Spine Hospital and Research Institute SSHRI

Ahmedabad, Gujarat, India

MS Ramaiah Medical College and Hospitals

Bangalore, Karnataka, India

King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College

Mumbai, Maharashtra, India

Outcomes

Primary Outcomes

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

Time frame: Up to 12 months

Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE)

Time frame: Up to 12 months

Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments

Time frame: Baseline, Month 12

Number of Participants With Clinically Significant Changes in Vital Signs

Time frame: Baseline, Month 12

Secondary Outcomes

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

Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip

Time frame: At 6 months and 12 months

Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck

Time frame: At 6 months and 12 months

Data from ClinicalTrials.gov

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