Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

Phase 3

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00100620
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-01-03
• Study First Submitted QC: 2005-01-03
• Study First Posted: 2005-01-04
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 802

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.

Secondary Outcome Measures

Name	Time	Method
Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline
Percent 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

Trial Locations

Locations (6)

McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States

United Osteoporosis Centers; 🇺🇸 Gainesville, Georgia, United States

Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders; 🇺🇸 Birmingham, Alabama, United States

University of Ohio; 🇺🇸 Columbus, Ohio, United States

Osteoporosis & Clinical Trials; 🇺🇸 Cumberland, Maryland, United States

Radiant Research; 🇺🇸 Wyomissing, Pennsylvania, United States