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Risedronate therapy prevents corticosteroid-induced bone loss: a twelve-month, multicenter, randomized, double-blind,

S Cohen1, R M Levy, M Keller

  • 1Metroplex Clinical Research, Dallas, Texas 75235, USA.

Arthritis and Rheumatism
|November 11, 1999
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Summary

Daily oral risedronate (a bisphosphonate) effectively prevents bone loss in patients starting long-term corticosteroid therapy. This treatment maintained bone mineral density and was well-tolerated over 12 months.

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Area of Science:

  • Pharmacology
  • Bone Metabolism
  • Endocrinology

Background:

  • Corticosteroids are widely used for chronic inflammatory conditions.
  • Long-term corticosteroid use is associated with significant bone loss and increased fracture risk.
  • Bisphosphonates are a class of drugs known for their potent antiresorptive properties.

Purpose of the Study:

  • To evaluate the safety and efficacy of daily oral risedronate for preventing corticosteroid-induced bone loss.
  • To assess the impact of risedronate on bone mineral density (BMD) and vertebral fracture incidence.
  • To determine the optimal dosage of risedronate for this indication.

Main Methods:

  • A multicenter, randomized, double-blind, placebo-controlled study involving 224 patients initiating long-term corticosteroid treatment.
  • Patients received daily oral risedronate (2.5 mg or 5 mg) or placebo for 12 months, along with daily calcium supplementation.
  • Primary outcome was the percentage change in lumbar spine bone mineral density (BMD); secondary outcomes included proximal femur BMD and vertebral fracture incidence.

Main Results:

  • Risedronate therapy, particularly the 5 mg dose, significantly prevented bone loss at the lumbar spine and proximal femur compared to placebo.
  • Lumbar spine BMD showed no significant change from baseline in the 5 mg risedronate group, while it decreased in the placebo group.
  • A trend towards reduced vertebral fracture incidence was observed in the 5 mg risedronate group (5.7%) versus placebo (17.3%).
  • Risedronate was well-tolerated, with a comparable incidence of upper gastrointestinal adverse events across all groups.

Conclusions:

  • Daily oral risedronate is an effective therapy for preventing bone loss in patients starting long-term corticosteroid treatment.
  • The 5 mg daily dose of risedronate demonstrated significant benefits in maintaining bone mineral density.
  • Risedronate represents a safe and effective option for mitigating a common side effect of corticosteroid therapy.