Postmenopausal Osteoporosis
Conditions
Keywords
Romosozumab, EVENITY®, Osteoporosis, Women Health
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.
Interventions
DRUGRomosozumab
Single-use prefilled syringe for SC injection.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
India
Outcome results
None listed