Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial.

Academic Article

Abstract

  • OBJECTIVE: Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy. METHODS: We conducted a 12-month, multicenter, randomized, double-blind, placebo-controlled trial with 114 and 59 patients in the treatment and placebo arms, respectively. Participants were stratified according to the duration of prior oral glucocorticoid therapy at randomization. Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D. Clinical evaluations were performed at baseline, 3, 6, 9, and 12 months. RESULTS: At 12 months, there was a significant mean percentage increase from baseline in the ALN OW group for lumbar spine (2.45%), trochanter (1.27%), total hip (0.75%), and total body (1.70%) bone mineral density (BMD). Comparing ALN OW versus placebo at 12 months, a significant treatment difference for the mean percentage change from baseline was observed for lumbar spine (treatment difference of 2.92%; p
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    Keywords

  • Administration, Oral, Adult, Aged, Alendronate, Biomarkers, Bone Density, Bone Density Conservation Agents, Calcium, Drug Therapy, Combination, Female, Glucocorticoids, Hip Joint, Humans, Lumbar Vertebrae, Male, Middle Aged, Osteoporosis, Placebos, Rheumatic Diseases, Vitamin D
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    Author List

  • Stoch SA; Saag KG; Greenwald M; Sebba AI; Cohen S; Verbruggen N; Giezek H; West J; Schnitzer TJ
  • Start Page

  • 1705
  • End Page

  • 1714
  • Volume

  • 36
  • Issue

  • 8