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



Status:Completed
Conditions:Osteoporosis, Osteoporosis, Postmenopausal Syndrome
Therapuetic Areas:Endocrinology, Rheumatology
Healthy:No
Age Range:55 - 100
Updated:4/13/2017
Start Date:May 2014
End Date:July 2015

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

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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)
We found this trial at
11
sites
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Detroit, MI
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Akron, OH
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Albuquerque, NM
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Bend, OR
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Bethesda, MD
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Gainesville, GA
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Lakewood, CO
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Santa Maria, CA
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South Lake Tahoe, California 96150
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South Lake Tahoe, CA
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Vancouver,
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