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Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732770
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : January 25, 2016
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.

Condition or disease Intervention/treatment Phase
Post Menopausal Osteoporosis Biological: Denosumab Drug: Zoledronic Acid Drug: Placebo to Denosumab Drug: Placebo to Zoledronic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 643 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
Actual Study Start Date : November 7, 2012
Actual Primary Completion Date : January 7, 2015
Actual Study Completion Date : January 7, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Biological: Denosumab
Denosumab 60 mg administered by subcutaneous injection once every 6 months.
Other Names:
  • Prolia®
  • AMG 162

Drug: Placebo to Zoledronic Acid
Administered by intravenous infusion once a year

Active Comparator: 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.
Drug: Zoledronic Acid
Zoledronic acid 5 mg administered by intravenous infusion once a year
Other Names:
  • Reclast
  • Aclasta

Drug: Placebo to Denosumab
Administered by subcutaneous injection once every 6 months




Primary Outcome Measures :
  1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis [ Time Frame: Baseline and Month 12 ]
    Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis [ Time Frame: Baseline and Month 12 ]
    BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility.

  2. Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis [ Time Frame: Baseline and Month 12 ]
  3. Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis [ Time Frame: Baseline and Month 12 ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory postmenopausal women.
  • 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:

  • Received other osteoporosis treatment or bone active treatment
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732770


Locations
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United States, California
Research Site
Santa Monica, California, United States, 90404
United States, Colorado
Research Site
Lakewood, Colorado, United States, 80227
Research Site
Longmont, Colorado, United States, 80501
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20007
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20817
Research Site
Hagerstown, Maryland, United States, 21740
United States, Michigan
Research Site
Detroit, Michigan, United States, 48236
United States, New York
Research Site
West Haverstraw, New York, United States, 10993
United States, Texas
Research Site
Houston, Texas, United States, 77074
Australia, New South Wales
Research Site
Maroubra, New South Wales, Australia, 2035
Research Site
Penrith, New South Wales, Australia, 2750
Research Site
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
Research Site
Box Hill, Victoria, Australia, 3128
Research Site
Geelong, Victoria, Australia, 3220
Research Site
Parkville, Victoria, Australia, 3050
Belgium
Research Site
Brussels, Belgium, 1050
Research Site
Brussel, Belgium, 1090
Research Site
Bruxelles, Belgium, 1000
Research Site
Bruxelles, Belgium, 1020
Research Site
Genk, Belgium, 3600
Research Site
Leuven, Belgium, 3000
Research Site
Liège, Belgium, 4020
Research Site
Merksem, Belgium, 2170
Research Site
Tessenderlo, Belgium, 3980
Research Site
Wilrijk, Belgium, 2610
Research Site
Yvoir, Belgium, 5530
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M5C 2T2
Research Site
Toronto, Ontario, Canada, M5G 2C4
Research Site
Toronto, Ontario, Canada, M9W 4L6
Canada
Research Site
Quebec, Canada, G1V 3M7
Denmark
Research Site
Aalborg, Denmark, 9000
Research Site
Ballerup, Denmark, 2750
Research Site
Vejle, Denmark, 7100
Poland
Research Site
Bialystok, Poland, 15-879
Research Site
Kraków, Poland, 31-501
Research Site
Torun, Poland, 87-100
Research Site
Warszawa, Poland, 01-192
Spain
Research Site
Granada, Andalucía, Spain, 18012
Research Site
Barcelona, Cataluña, Spain, 08036
Research Site
Barcelona, Cataluña, Spain, 08041
Research Site
Madrid, Spain, 28009
Research Site
Madrid, Spain, 28040
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01732770    
Other Study ID Numbers: 20110153
2012-001821-28 ( EudraCT Number )
First Posted: November 26, 2012    Key Record Dates
Results First Posted: January 25, 2016
Last Update Posted: March 10, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs