A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

Completed · Phase 3

Conditions studied: Postmenopausal Osteoporosis

In brief

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Key facts

Study ID

NCT02157948

Run by

Amgen

People needed

394

Starts

2014-05-01

Expected to finish

2015-07-01

Last updated by the study team

2017-08-16

Who can join

Age: 55 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject has provided informed consent prior to any study-specific activities/procedures
• Ambulatory postmenopausal women.
• Age 55 years or older
• Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.

You may not qualify if…

• Administration of osteoporosis treatments or bone active treatments within specific timeframes
• Vitamin D deficiency
• Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
• Contraindications to denosumab therapy (e.g., hypocalcemia)

Where it is running

• Research Site — Santa Maria, California, United States
• Research Site — South Lake Tahoe, California, United States
• Research Site — Lakewood, Colorado, United States
• Research Site — Gainesville, Georgia, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Akron, Ohio, United States
• Research Site — Bend, Oregon, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Vancouver, British Columbia, Canada
• Research Site — Québec, Quebec, Canada
• Research Site — Westmout, Quebec, Canada
• Research Site — Aalborg, Denmark
• Research Site — Ballerup Municipality, Denmark
• Research Site — Vejle, Denmark
• Research Site — Bialystok, Poland
• Research Site — Gliwice, Poland
• Research Site — Krakow, Poland
• Research Site — Lodz, Poland
• Research Site — Lodz, Poland
• Research Site — Świdnik, Poland
• Research Site — Warsaw, Poland

Full record on ClinicalTrials.gov

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