A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
NCT ID: NCT02157948
Last Updated: 2017-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
394 participants
INTERVENTIONAL
2014-05-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Denosumab CP2
Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
Denosumab (CP2)
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
Denosumab CP4
Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
Denosumab (CP4)
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
Interventions
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Denosumab (CP2)
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
Denosumab (CP4)
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
55 Years
100 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-001279-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120187
Identifier Type: -
Identifier Source: org_study_id
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