Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis



Status:Completed
Conditions:Osteoporosis, Postmenopausal Syndrome
Therapuetic Areas:Endocrinology, Rheumatology
Healthy:No
Age Range:55 - 90
Updated:2/21/2019
Start Date:March 15, 2012
End Date:December 28, 2016

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A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

The purpose of this study is to determine if treatment with romosozumab is effective in
preventing fractures in women with postmenopausal osteoporosis


Inclusion Criteria:

- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score
at the total hip or femoral neck of ≤ -2.50)

Exclusion Criteria:

- BMD T-score of ≤ -3.50 at the total hip or femoral neck

- History of hip fracture

- Any severe or more than 2 moderate vertebral fractures, as assessed by the central
imaging based on lateral spine x-rays

- Use of agents affecting bone metabolism

- History of metabolic or bone disease (except osteoporosis)

- Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)

- Current hyper- or hypocalcemia

- Current, uncontrolled hyper- or hypothyroidism

- Current, uncontrolled hyper- or hypoparathyroidism
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