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NCT00100620 Clinical Trial

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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00100620
Other study ID # CZOL446O2306
Secondary ID
Status Completed
Phase Phase 3
First received January 3, 2005
Last updated May 15, 2017
Start date June 2004
Est. completion date April 2007

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 802
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Zoledronic Acid

Locations
Country Name City State
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 United Osteoporosis Centers Gainesville Georgia
United States McGuire VA Medical Center Richmond Virginia
United States Radiant Research Wyomissing Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
Secondary Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline
Secondary Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline
Secondary Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12
Secondary Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy
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