Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Teriparatide; Drug: Placebo; Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00439244

CZOL446H2409

Details and patient eligibility

About

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

Enrollment: 412 patients

Sex: Female

Ages: 45 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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412 participants in 3 patient groups

Zoledronic acid plus teriparatide

Active Comparator group

Description:

Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. 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. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.

Treatment:

Drug: Zoledronic acid

Drug: Teriparatide

Zoledronic acid

Experimental group

Description:

Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.

Treatment:

Drug: Zoledronic acid

Placebo zoledronic acid plus teriparatide

Active Comparator group

Description:

Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). 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. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.

Treatment:

Drug: Teriparatide

Drug: Placebo