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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01732770
First received: November 20, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

This study will compare the effectiveness of Denosumab treatment Q6M with once yearly Zoledronic Acid treatment on Bone Mineral Density (BMD) at various skeletal sites.


Condition Intervention Phase
Post Menopausal Osteoporosis
Drug: Denosumab
Drug: Zoledronic Acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • Bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 643
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denosumab 60 mg SC Q6M
Denosumab 60 mg SC Q6M for 12 months and placebo for Zoledronic Acid IV once yearly
Drug: Denosumab
Denosumab 60 mg SC Q6M for 12 months
Active Comparator: Zoledronic Acid 5 mg IV once yearly
Zoledronic Acid 5 mg IV once yearly and placebo for Denosumab SC Q6M for 12 months
Drug: Zoledronic Acid
Zoledronic Acid 5 mg IV once yearly

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders 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 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732770

  Show 46 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01732770     History of Changes
Other Study ID Numbers: 20110153, 2012-001821-28
Study First Received: November 20, 2012
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Office for Radiation Protection
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Germany: Paul-Ehrlich-Institut
Denmark: Danish Health and Medicines Authority
Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on November 25, 2014