A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the
following treatment groups:

- Romosozumab 90 mg/mL

- Placebo 90 mg/mL

- Romosozumab 70 mg/mL

- Placebo 70 mg/mL

After completing a 6-month treatment period, participants entered a 3-month follow-up period
with an end of study (EOS) at month 9.

For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single
placebo group. For safety analyses, the data for placebo were presented separately for each
group.

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.