Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
NCT ID: NCT00439244
Last Updated: 2011-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
412 participants
INTERVENTIONAL
2006-12-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Zoledronic acid plus teriparatide
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.
Zoledronic acid
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.
Teriparatide
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.
Zoledronic acid
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.
Zoledronic acid
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.
Placebo zoledronic acid plus teriparatide
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.
Placebo
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
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.
Interventions
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Zoledronic acid
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.
Placebo
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
45 Years
89 Years
FEMALE
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Locations
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Birmingham, Alabama, United States
Beverly Hills, California, United States
Novartis Investigative Site
La Mesa, California, United States
Novartis Investigative Site
Oakland, California, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Gainesville, Georgia, United States
Morton Grove, Illinois, United States
Urbandale, Iowa, United States
Bangor, Maine, United States
Novartis Investigative Site
Woodbury, Minnesota, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Albuquerque, New Mexico, United States
West Haverstraw, New York, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Spokane, Washington, United States
Madison, Wisconsin, United States
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative site
Godinne, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Magdeburg, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative site
Würzburg, , Germany
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Granada, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Valencia, , Spain
Countries
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Other Identifiers
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CZOL446H2409
Identifier Type: -
Identifier Source: org_study_id
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