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

Completed · Phase 3 · Has a placebo group

Conditions studied: Postmenopausal Osteoporosis

In brief

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

Key facts

Study ID

NCT02016716

Run by

Amgen

People needed

294

Starts

2013-12-03

Expected to finish

2014-12-08

Last updated by the study team

2018-11-08

Who can join

Age: 55 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Gainesville, Georgia, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Brno, Czechia
• Research Site — Klatovy, Czechia
• Research Site — Uherské Hradiště, Czechia
• Research Site — Gdynia, Poland
• Research Site — Gliwice, Poland
• Research Site — Katowice, Poland
• Research Site — Krakow, Poland
• Research Site — Świdnik, Poland
• Research Site — Warsaw, Poland
• Research Site — Wroclaw, Poland

Full record on ClinicalTrials.gov

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