A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
NCT ID: NCT02016716
Last Updated: 2018-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
294 participants
INTERVENTIONAL
2013-12-03
2014-12-08
Brief Summary
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Detailed Description
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* Romosozumab 90 mg/mL
* Placebo 90 mg/mL
* Romosozumab 70 mg/mL
* Placebo 70 mg/mL
After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.
For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Romosozumab 90 mg/mL
Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Romosozumab 90 mg/mL
Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
Placebo 90 mg/mL
Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.
Placebo 90 mg/mL
Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
Romosozumab 70 mg/mL
Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.
Romosozumab 70 mg/mL
Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
Placebo 70 mg/mL
Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.
Placebo 70 mg/mL
Placebo administered as 3 SC injections with the 1.0 mL glass PFS.
Interventions
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Romosozumab 90 mg/mL
Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
Placebo 90 mg/mL
Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
Romosozumab 70 mg/mL
Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
Placebo 70 mg/mL
Placebo administered as 3 SC injections with the 1.0 mL glass PFS.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
* a history of fragility fracture or at least 2 other risk factors
Exclusion Criteria
* History of hip fracture.
* 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.
55 Years
90 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
Gainesville, Georgia, United States
Research Site
Bethesda, Maryland, United States
Research Site
Brno, , Czechia
Research Site
Klatovy, , Czechia
Research Site
Uherské Hradiště, , Czechia
Research Site
Gdynia, , Poland
Research Site
Gliwice, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Świdnik, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-000434-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120156
Identifier Type: -
Identifier Source: org_study_id
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