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

Completed · Phase 3

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00100620

Run by

Novartis Pharmaceuticals

People needed

802

Starts

2004-06-01

Expected to finish

2007-04-01

Last updated by the study team

2017-05-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Long duration treatment with corticosteroids (started or ongoing)

You may not qualify if…

• 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.

Where it is running

• Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders — Birmingham, Alabama, United States
• United Osteoporosis Centers — Gainesville, Georgia, United States
• Osteoporosis & Clinical Trials — Cumberland, Maryland, United States
• University of Ohio — Columbus, Ohio, United States
• Radiant Research — Wyomissing, Pennsylvania, United States
• McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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