Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Denosumab; Zoledronic Acid; Placebo to Denosumab; Placebo to Zoledronic Acid
Intervention description: Denosumab 60 mg administered by subcutaneous injection once every 6 months.; Zoledronic acid 5 mg administered by intravenous infusion once a year; Administered by subcutaneous injection once every 6 months; Administered by intravenous infusion once a year
Intervention MeSH terms: Zoledronic Acid; Denosumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 643.0
Sex: Female
Minimum age: 55 Years
Healthy volunteers: No

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.
    

Eligibility 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