An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
NCT ID: NCT00799266
Last Updated: 2020-09-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
34 participants
INTERVENTIONAL
2008-12-04
2018-03-05
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
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Zoledronic acid
intravenous infusion
Placebo
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Placebo
intravenous infusion
Interventions
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Zoledronic acid
intravenous infusion
Placebo
intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Lumbar Spine BMDZ-score of -0.5 or worse
* Evidence of at least at least 1 vertebral compression fracture of Genant Grade 1 or higher (or radiographic signs of vertebral fracture) within 1 month from Screening visit OR One or more, low-trauma, lower extremity long-bone fracture which occurred sometime within the 2 years PRECEDING enrollment in the study OR Two or more, low-trauma, upper extremity long-bone fractures which occurred sometime within the 2 years PRECEDING enrollment in the study
* Consent/assent to study participation
Exclusion Criteria
* Any medical condition that might have interfered with the evaluation of lumbar spine BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable vertebrae by Dual Energy X-ray Absorptiometry (DXA) evaluation in the region of interest lumbar 1 (L1) to lumbar 4 (L4),
* Hypocalcemia and hypophosphatemia
* Serum 25-hydroxy vitamin D concentrations of \<20 ng/mL or \<50 nmol/L
* estimated glomerular filtration rate (GFR) \<60 mL/min/1.73 m2
* serum creatinine increase between Visit 1 and Visit 2 \>0.5 mg/dL (44.2 μmol/L)
* Uncontrolled symptoms of cardiac failure or arrhythmia
* Any prior use of bisphosphonates, or high dose sodium fluoride
5 Years
17 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Winnipeg, Manitoba, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Soweto, Gauteng, South Africa
Novartis Investigative Site
West Midlands, Birmingham, United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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References
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Ward LM, Choudhury A, Alos N, Cabral DA, Rodd C, Sbrocchi AM, Taback S, Padidela R, Shaw NJ, Hosszu E, Kostik M, Alexeeva E, Thandrayen K, Shenouda N, Jaremko JL, Sunkara G, Sayyed S, Aftring RP, Munns CF. Zoledronic Acid vs Placebo in Pediatric Glucocorticoid-induced Osteoporosis: A Randomized, Double-blind, Phase 3 Trial. J Clin Endocrinol Metab. 2021 Nov 19;106(12):e5222-e5235. doi: 10.1210/clinem/dgab458.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2008-001252-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CZOL446H2337
Identifier Type: -
Identifier Source: org_study_id
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