Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic acid; Placebo; Teriparatide
Intervention description: Zoledronic acid 5.0 mg in a ready-to-infuse plastic bottle with a total fill volume of 103 mL to allow an infusion of 100 mL total volume corresponding to 5 mg of zoledronic acid.; Zoledronic acid matched placebo as a 103 mL solution of sterile water (physiologic 0.9% normal saline) to allow an infusion of 100 mL total volume in a ready-to-infuse plastic bottle; Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. Each pre-filled delivery device is filled with 3.3 mL to deliver 3 mL.
Each mL contains 250 μg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetate acid, 0.10 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3.0 mg Metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge pre-assembled into a pen device delivers 20 μg of teriparatide per dose each day for up to 28 days.
Intervention MeSH terms: Zoledronic Acid; Teriparatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 412.0
Sex: Female
Minimum age: 45 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Bone Mineral Density (BMD); C-Telopeptides (CTx); dual x-ray absorptiometry (DXA); pro-collagen type 1 N-propeptide (P1NP); teriparatide; zoledronic acid; Osteoporosis; postmenopausal women

Summary:

      The purpose of this study is to assess the effects of zoledronic acid administered at the
      same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone
      mineral density (BMD) gain in the lumbar spine and total hip
    

Eligibility criteria:

        Inclusion criteria:

          -  Postmenopausal (PMO) women between 45 and 89 years of age.

          -  Bone mineral density T score of -2.5 or less at femoral neck, total hip or lumbar
             spine OR

          -  Bone mineral density T score of -2.0 or less at femoral neck, total hip or lumbar
             spine with at least one documented osteoporotic vertebral fracture or a previously
             documented history of an osteoporotic clinical non-vertebral fracture not due to
             excessive trauma

        Exclusion criteria:

          -  Any prior use of strontium

          -  Any past or active kidney disease or problems with kidney function

          -  Prior treatment with any intravenous (i.v.) or oral bisphosphonate (such as but not
             limited to alendronate, risedronate and pamidronate) longer than 3 months
             consecutively. If bisphosphonate exposure is less than or equal to 3 months , a
             washout period of 1 year to randomization is required

          -  Calcium levels in blood within the normal range

          -  Normal liver function

          -  Non-osteoporotic forms of metabolic bone disease such as and not limited to Paget's
             disease of bone, osteomalacia, osteogenesis imperfecta or multiple myeloma

          -  Less than 3 evaluable lumbar (L1-L4) vertebrae for dual energy x-ray absorptiometry
             (DXA) measurement

          -  Treatment with osteoporotic therapies such as raloxifene, calcitonin or Hormone
             Replacement Therapy within 3 months of randomization

          -  Allergy or previous exposure to teriparatide

        Other protocol-defined inclusion/exclusion criteria may apply