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

J Pediatr Rehabil Med. 2013;6(2):85-93. doi: 10.3233/PRM-130242.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorptiometry, Photon
  • Adolescent
  • Adult
  • Alkaline Phosphatase / blood
  • Biomarkers / blood
  • Bone Density / drug effects*
  • Bone Density Conservation Agents / administration & dosage*
  • Cerebral Palsy / pathology*
  • Child
  • Collagen Type I / blood
  • Double-Blind Method
  • Etidronic Acid / administration & dosage
  • Etidronic Acid / analogs & derivatives*
  • Female
  • Humans
  • Lumbar Vertebrae / diagnostic imaging
  • Lumbar Vertebrae / drug effects*
  • Male
  • Osteocalcin / blood
  • Peptides / blood
  • Risedronic Acid
  • Treatment Outcome
  • Young Adult

Substances

  • Biomarkers
  • Bone Density Conservation Agents
  • Collagen Type I
  • Peptides
  • collagen type I trimeric cross-linked peptide
  • Osteocalcin
  • Alkaline Phosphatase
  • Risedronic Acid
  • Etidronic Acid