Affiliations: Division of Pediatric Gastroenterology, Hepatology,
and Nutrition, The Ann and Robert H. Lurie Children's Hospital of Chicago,
Chicago, IL, USA | Division of Biostatistics and Epidemiology, Cincinnati
Children's Hospital Medical Center, Cincinnati, OH, USA | Division of Gastroenterology, Cincinnati Children's
Hospital Medical Center, Cincinnati, OH, USA
Note: [] Corresponding author: James Heubi, University of Cincinnati
College of Medicine, Cincinnati Children's Hospital Medical Center, 240 Albert
Sabin Way, Room S10-313, Cincinnati, OH~ 45229, USA. Tel.: +1 513 636 8046;
Fax: +1 513 803 1039; E-mail: [email protected]
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.
Keywords: Bone mineral density, bisphosphonates, cerebral palsy, children
