- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439244
Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
A One-year Partial Double-blinded, Randomized, Multi-center, Multi-national Study to Assess the Effects of Combination Therapy of Annual Zoledronic Acid (5 mg) and Daily Subcutaneous Teriparatide (2mcrg) on Postmenopausal Women With Severe Osteoporosis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bruxelles, Belgium
- Novartis Investigative Site
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Gent, Belgium
- Novartis Investigative Site
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Godinne, Belgium
- Novartis Investigative Site
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Leuven, Belgium
- Novartis Investigative Site
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Liege, Belgium
- Novartis Investigative Site
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Essen, Germany
- Novartis Investigative Site
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Hannover, Germany
- Novartis Investigative Site
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Heidelberg, Germany
- Novartis Investigative Site
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Magdeburg, Germany
- Novartis Investigative Site
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Munchen, Germany
- Novartis Investigative Site
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Wuerzburg, Germany
- Novartis Investigative Site
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Barcelona, Spain
- Novartis Investigative Site
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Granada, Spain
- Novartis Investigative Site
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Madrid, Spain
- Novartis Investigative Site
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Valencia, Spain
- Novartis Investigative Site
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Alabama
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Birmingham, Alabama, United States, 35294
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California
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Beverly Hills, California, United States, 90211
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La Mesa, California, United States
- Novartis Investigative Site
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Oakland, California, United States
- Novartis Investigative Site
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Colorado
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Colorado Springs, Colorado, United States, 80910
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Lakewood, Colorado, United States, 80227
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Georgia
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Gainesville, Georgia, United States, 30501
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Illinois
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Morton Grove, Illinois, United States, 60053
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Iowa
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Urbandale, Iowa, United States, 50322
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Maine
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Bangor, Maine, United States, 04401
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Minnesota
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Woodbury, Minnesota, United States
- Novartis Investigative Site
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Missouri
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St. Louis, Missouri, United States, 63110
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Nebraska
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Lincoln, Nebraska, United States, 68516
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New Mexico
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Albuquerque, New Mexico, United States, 87106
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New York
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West Haverstraw, New York, United States, 10993
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15253
- Novartis Investigative Site
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Washington
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Spokane, Washington, United States
- Novartis Investigative Site
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Wisconsin
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Madison, Wisconsin, United States, 53705
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: 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.
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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.
Other Names:
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 Names:
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EXPERIMENTAL: 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.
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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.
Other Names:
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ACTIVE_COMPARATOR: 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.
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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 Names:
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
Time Frame: Baseline through Week 52
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BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination).
Every attempt was made to obtain the BMD measurements at the scheduled visit.
If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained.
For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit.
BMD scans were acquired locally and all results sent to a central reader for evaluation.
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Baseline through Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26
Time Frame: Baseline through Week 13 and Week 26
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BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination).
Every attempt was made to obtain the BMD measurements at the scheduled visit.
If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained.
For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit.
BMD scans were acquired locally and all results sent to a central reader for evaluation.
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Baseline through Week 13 and Week 26
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Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52
Time Frame: Baseline through Week 13, Week 26 and Week 52
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BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination).
Every attempt was made to obtain the BMD measurements at the scheduled visit.
If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained.
For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit.
BMD scans were acquired locally and all results sent to a central reader for evaluation.
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Baseline through Week 13, Week 26 and Week 52
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Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)
Time Frame: At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
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Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52.
The amount of serum P1NP was determined by the central laboratory.
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At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
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Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)
Time Frame: At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
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Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52.
The amount of serum β-CTx was determined by the central laboratory.
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At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CZOL446H2409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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