A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
Postmenopausal Osteoporosis
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Postmenopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women with osteoporosis at high risk for fracture defined as
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
- a history of fragility fracture or at least 2 other risk factors
Exclusion Criteria:
- BMD T score < -3.50 at the total hip or femoral neck.
- History of hip fracture.
- History of metabolic or bone disease (except osteoporosis).
- Use of agents affecting bone metabolism.
- Vitamin D insufficiency.
- History of solid organ or bone marrow transplants.
- Hyper- or hypocalcemia.
- Hyper- or hypothyroidism.
- Hyper- or hypoparathyroidism.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Romosozumab 90 mg/mL
Placebo 90 mg/mL
Romosozumab 70 mg/mL
Placebo 70 mg/mL
Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.
Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.
Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.