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

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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

Tracking Information
First Submitted Date  ICMJE November 20, 2012
First Posted Date  ICMJE November 26, 2012
Results First Submitted Date  ICMJE December 9, 2015
Results First Posted Date  ICMJE January 25, 2016
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE November 7, 2012
Actual Primary Completion Date January 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
Bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months [ Time Frame: 12 Months ]
The primary objective of this study is to evaluate if the effect of administering Denosumab (60 mg subcutaneously [SC] every 6 months [Q6M]) is not inferior to that of Zoledronic Acid (5 mg intravenously [IV] once yearly) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates with respect to change in bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
BMD by DXA of total hip at 12 months (non-inferiority); BMD by DXA of lumbar spine at 12 months (superiority); BMD by DXA of total hip at 12 months (superiority) [ Time Frame: 12 Months ]
Secondary Objective(s): Compare the efficacy of administering Denosumab (60 mg SC Q6M) with that of Zoledronic Acid (5 mg IV once yearly) on the following: BMD by DXA of total hip at 12 months (non-inferiority); BMD by DXA of lumbar spine at 12 months (superiority); BMD by DXA of total hip at 12 months (superiority)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post Menopausal Osteoporosis
Intervention  ICMJE
  • Biological: Denosumab
    Denosumab 60 mg administered by subcutaneous injection once every 6 months.
    Other Names:
    • Prolia®
    • AMG 162
  • 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
  • Drug: Placebo to Zoledronic Acid
    Administered by intravenous infusion once a year
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: Denosumab
    • Drug: Placebo to Zoledronic Acid
  • 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.
    Interventions:
    • Drug: Zoledronic Acid
    • Drug: Placebo to Denosumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2014)
643
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2012)
620
Actual Study Completion Date  ICMJE January 7, 2015
Actual Primary Completion Date January 7, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Denmark,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01732770
Other Study ID Numbers  ICMJE 20110153
2012-001821-28 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP