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



Status:Completed
Conditions:Osteoporosis, Osteoporosis, Postmenopausal Syndrome
Therapuetic Areas:Endocrinology, Rheumatology
Healthy:No
Age Range:55 - 90
Updated:11/10/2018
Start Date:December 3, 2013
End Date:December 8, 2014

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A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone
mineral density (BMD) 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.
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