Efficacy and Safety of Romosozumab Treatment 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 determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Key facts

Study ID

NCT01575834

Run by

Amgen

People needed

7180

Starts

2012-03-15

Expected to finish

2016-12-28

Last updated by the study team

2024-08-28

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Research Site — Laguna Hills, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Santa Maria, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Lakewood, Colorado, United States
• Research Site — Leesburg, Florida, United States
• Research Site — Palm Harbor, Florida, United States
• Research Site — Plantation, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Gainesville, Georgia, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Mayfield, Ohio, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Denton, Texas, United States
• Research Site — Richmond, Virginia, United States
• Research Site — Madison, Wisconsin, United States
• Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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