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OpenTrials
Completed

NCT Number: NCT00100620

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

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

Secondary outcomes

  1. Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline

  2. Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline

  3. Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12

  4. Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jan 4, 2005
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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