Oral risedronate sodium improves bone mineral density in non-ambulatory patients: A randomized, double-blind, placebo controlled trial

Valeria Cohran, Amy Cassedy, Andre Hawkins, Judy Bean, James Heubi*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

AIMS: Investigate the efficacy of risedronate sodium (Procter and Gamble, Cincinnati, USA) for treating reduced lumbar spine (LS) bone mineral density (BMD) in non-ambulatory patients. METHODS: Nine (10-39 years, mean age 23.0 years, 7 males) in the risedronate arm and 10 (10-35 years, mean age 21.4 years, 8 males) in the placebo arm completed 24 months of therapy at baseline, 6, 12, 18, and 24 months. The primary outcome was change in LS BMD assessed by dual energy x-ray absorptiometry (DXA). Secondary outcomes included changes in serum bone markers, bone specific alkaline phosphatase, osteocalcin, and N-telopeptides. Mixed models examined group, time, and the group by time interaction for the 4 post-baseline time points. RESULTS: The change in LS BMD score from baseline to 24 months was 0.069 (95% CI 0.014 to 0.124) in risedronate participants compared to -0.015 (95% CI -0.073 to 0.042) (t Value = -2.40, P > t=0.03) in the controls. When controlling for baseline scores, the difference was consistent across four post-baseline time points tested (F=5.67, Pr > F=0.03). No differences in serum bone markers were observed. CONCLUSIONS: Risedronate increases LS BMD in non-ambulatory patients with minimal side effects.

Original languageEnglish (US)
Pages (from-to)85-93
Number of pages9
JournalJournal of pediatric rehabilitation medicine
Volume6
Issue number2
DOIs
StatePublished - 2013

Keywords

  • Bone mineral density
  • bisphosphonates
  • cerebral palsy
  • children

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Physical Therapy, Sports Therapy and Rehabilitation
  • Rehabilitation

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