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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732770
First Posted: November 26, 2012
Last Update Posted: February 26, 2016
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.
Information provided by (Responsible Party):
Amgen
  Purpose
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 Intervention Phase
Post Menopausal Osteoporosis Biological: Denosumab Drug: Zoledronic Acid Drug: Placebo to Denosumab Drug: Placebo to Zoledronic Acid Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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:
  • 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.

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

Enrollment: 643
Study Start Date: November 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


  Show 45 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01732770     History of Changes
Other Study ID Numbers: 20110153
2012-001821-28 ( EudraCT Number )
First Submitted: November 20, 2012
First Posted: November 26, 2012
Results First Submitted: December 9, 2015
Results First Posted: January 25, 2016
Last Update Posted: February 26, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Diphosphonates
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs