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

Sponsored by Amgen

Phase Quota
Phase 4

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.

Study Start Date: November 2012

Estimated Completion Date: January 2015

Specialties: Obstetrics & Gynecology: Clinical Pharmacology,Menopausal Medicine Family Medicine: Women`s Health Endocrinology: Bone Metabolism Orthopedics: Bone Metabolism

Interventions

  • Drug: Placebo to Zoledronic Acid
  • Drug: Denosumab
  • Biological: Denosumab
  • Drug: Placebo to Denosumab
  • Drug: Zoledronic Acid

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

Study Locations And Contact Information

  • Research Site, Bialystok
  • Research Site, Bruxelles
  • Research Site, Bethesda Maryland
  • Research Site, Parkville Victoria
  • Research Site, Torun
  • Research Site, Santa Monica California
  • Research Site, Detroit Michigan
  • Research Site, Calgary Alberta
  • Research Site, Madrid
  • Research Site, Genk
  • Research Site, Madrid
  • Research Site, Madrid
  • Research Site, Kraków
  • Research Site, Bethesda Maryland
  • Research Site, Houston Texas
  • Research Site, Madrid
  • Research Site, St Leonards New South Wales
  • Research Site, Tessenderlo
  • Research Site, Genk
  • Research Site, Vejle
  • Research Site, Warszawa
  • Research Site, Wilrijk
  • Research Site, Washington District of Columbia
  • Research Site, Wilrijk
  • Research Site, Brussel
  • Research Site, St Leonards New South Wales
  • Research Site, Geelong Victoria
  • Research Site, Washington District of Columbia
  • Research Site, Quebec
  • Research Site, Leuven
  • Research Site, Tessenderlo
  • Research Site, Halifax Nova Scotia
  • Research Site, Quebec
  • Research Site, Aalborg
  • Research Site, Vejle
  • Research Site, Barcelona Cataluña
  • Research Site, Barcelona Cataluña
  • Research Site, Brussels
  • Research Site, Halifax Nova Scotia
  • Research Site, Toronto Ontario
  • Research Site, Aalborg
  • Research Site, Toronto Ontario
  • Research Site, Yvoir
  • Research Site, Lakewood Colorado
  • Research Site, Brussel
  • Research Site, Calgary Alberta
  • Research Site, Liège
  • Research Site, Granada Andalucía
  • Research Site, Penrith New South Wales
  • Research Site, Toronto Ontario
  • Research Site, Toronto Ontario
  • Research Site, Bruxelles
  • Research Site, Ballerup
  • Research Site, Torun
  • Research Site, Liège
  • Research Site, Detroit Michigan
  • Research Site, Box Hill Victoria
  • Research Site, Merksem
  • Research Site, Parkville Victoria
  • Research Site, Ballerup
  • Research Site, Hagerstown Maryland
  • Research Site, Lakewood Colorado
  • Research Site, Bialystok
  • Research Site, Kraków
  • Research Site, Bruxelles
  • Research Site, Maroubra New South Wales
  • Research Site, West Haverstraw New York
  • Research Site, Vancouver British Columbia
  • Research Site, Box Hill Victoria
  • Research Site, Yvoir
  • Research Site, Leuven
  • Research Site, Barcelona Cataluña
  • Research Site, Longmont Colorado
  • Research Site, Warszawa
  • Research Site, Longmont Colorado
  • Research Site, Maroubra New South Wales
  • Research Site, Toronto Ontario
  • Research Site, Houston Texas
  • Research Site, Geelong Victoria
  • Research Site, Brussels
  • Research Site, Bruxelles
  • Research Site, Merksem

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