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


Phase 3
18 Years
85 Years
Not Enrolling
Both
Osteoporosis

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446O2306

NCT ID:

NCT00100620

Start Date:

June 2004

Completion Date:

April 2007

Related Keywords:

  • Osteoporosis
  • Corticosteroid induced osteoporosis
  • prevention
  • treatment
  • zoledronic acid
  • Osteoporosis

Name

Location

McGuire VA Medical CenterRichmond, Virginia  23249
Center for Education and research on Therapeutics (CERTs) of Musculoskeletal DisordersBirmingham, Alabama  35294-3708
United Osteoporosis CentersGainesville, Georgia  30501
Osteoporosis & Clinical TrialsCumberland, Maryland  21502
University of OhioColumbus, Ohio  43210
Radiant ResearchWyomissing, Pennsylvania  19610