Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Postmenopausal Women With Osteoporosis

In brief

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

Key facts

Study ID

NCT01631214

Run by

Amgen

People needed

4093

Starts

2012-05-04

Expected to finish

2017-06-29

Last updated by the study team

2025-02-21

Who can join

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

You may qualify if…

• Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:
• BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
• at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR
• at least 2 mild (SQ1) vertebral fractures OR
• BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
• at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
• a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.

You may not qualify if…

• 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
• Possible signs of intolerance to alendronate

Where it is running

• Research Site — Peoria, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Downey, California, United States
• Research Site — Greenbrae, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — South Lake Tahoe, California, United States
• Research Site — Tustin, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Lakewood, Colorado, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Stuart, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Gainesville, Georgia, United States
• Research Site — Maywood, Illinois, United States
• Research Site — Quincy, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Las Cruces, New Mexico, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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