Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
NCT ID: NCT01732770
Last Updated: 2020-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
643 participants
INTERVENTIONAL
2012-11-07
2015-01-07
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
DOUBLE
Study Groups
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Denosumab 60 mg
Participants received denosumab 60 mg subcutaneous injection once every 6 months for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
Denosumab
Denosumab 60 mg administered by subcutaneous injection once every 6 months.
Placebo to Zoledronic Acid
Administered by intravenous infusion once a year
Zoledronic Acid 5 mg
Participants received zoledronic acid 5 mg by intravenous infusion on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
Zoledronic Acid
Zoledronic acid 5 mg administered by intravenous infusion once a year
Placebo to Denosumab
Administered by subcutaneous injection once every 6 months
Interventions
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Denosumab
Denosumab 60 mg administered by subcutaneous injection once every 6 months.
Zoledronic Acid
Zoledronic acid 5 mg administered by intravenous infusion once a year
Placebo to Denosumab
Administered by subcutaneous injection once every 6 months
Placebo to Zoledronic Acid
Administered by intravenous infusion once a year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 55 years or older
* Subject has provided informed consent prior to any study specific procedures
* Received oral bisphosphonate therapy for osteoporosis at least 2 years prior to screening visit
* Screening BMD (g/cm²) values at the lumbar spine, total hip or femoral neck values of equal to or less than those listed in the protocol.
* At least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray absorptiometry (DXA) at the screening visit
Exclusion Criteria
* Evidence of history of any of the following:
* hyperthyroidism (stable on antithyroid therapy is allowed)
* hypothyroidism (stable on thyroid replacement therapy is allowed)
* hypo- or hyperparathyroidism
* hypo- or hypercalcemia based on the central laboratory reference ranges
* Recent tooth extraction (within 6 months of screening visit)
* Paget disease of bone (subject report or chart review)
* other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)
* Abnormalities of the following per central laboratory reference ranges:
* vitamin D deficiency (25\[OH\] vitamin D level \< 20 ng/mL), repletion will be allowed and subjects may be re-screened
* hypercalcemia
* elevated transaminases ≥ 2.0 x upper limits of normal (ULN)
* History of any solid organ or bone marrow transplant
* Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
* Known intolerance to calcium or vitamin D supplements
* Self-reported alcohol or drug abuse within 12 months prior to screening
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
* History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
55 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 Monica, California, United States
Research Site
Lakewood, Colorado, United States
Research Site
Longmont, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Bethesda, Maryland, United States
Research Site
Hagerstown, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
West Haverstraw, New York, United States
Research Site
Houston, Texas, United States
Research Site
Maroubra, New South Wales, Australia
Research Site
Penrith, New South Wales, Australia
Research Site
St Leonards, New South Wales, Australia
Research Site
Box Hill, Victoria, Australia
Research Site
Geelong, Victoria, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
Research Site
Genk, , Belgium
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Merksem, , Belgium
Research Site
Tessenderlo, , Belgium
Research Site
Wilrijk, , Belgium
Research Site
Yvoir, , Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Bialystok, , Poland
Research Site
Krakow, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Granada, Andalusia, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Countries
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References
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Miller PD, Pannacciulli N, Brown JP, Czerwinski E, Nedergaard BS, Bolognese MA, Malouf J, Bone HG, Reginster JY, Singer A, Wang C, Wagman RB, Cummings SR. Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates. J Clin Endocrinol Metab. 2016 Aug;101(8):3163-70. doi: 10.1210/jc.2016-1801. Epub 2016 Jun 6.
Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.
Chotiyarnwong P, McCloskey E, Eastell R, McClung MR, Gielen E, Gostage J, McDermott M, Chines A, Huang S, Cummings SR. A Pooled Analysis of Fall Incidence From Placebo-Controlled Trials of Denosumab. J Bone Miner Res. 2020 Jun;35(6):1014-1021. doi: 10.1002/jbmr.3972. Epub 2020 Apr 2.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-001821-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110153
Identifier Type: -
Identifier Source: org_study_id
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