Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With 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