Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Zoledronic Acid (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis
Summary
The intake of high doses of corticosteroids is known to play an important role in the
weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is
a drug known for its protective effect in some bone diseases (tumors, paget). This study will
test the safety and efficacy of zoledronic acid in the prevention and treatment of
corticosteroid induced osteoporosis in male and female patients.
Clinical Details
Official title: Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
Secondary outcome: Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baselinePercent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12 Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Long duration treatment with corticosteroids (started or ongoing)
Exclusion Criteria:
- History of osteogenesis imperfecta, multiple myeloma or Paget's disease
- History of Hyperparathyroidism, hyperthyroidism
- History of Osteomalacia
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders, Birmingham, Alabama 35294-3708, United States
United Osteoporosis Centers, Gainesville, Georgia 30501, United States
Osteoporosis & Clinical Trials, Cumberland, Maryland 21502, United States
University of Ohio, Columbus, Ohio 43210, United States
Radiant Research, Wyomissing, Pennsylvania 19610, United States
McGuire VA Medical Center, Richmond, Virginia 23249, United States
Additional Information
Patient e-portal for Novartis clinical trials
Starting date: June 2004
Last updated: September 25, 2007
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