Document Detail


Oral risedronate sodium improves bone mineral density in non-ambulatory patients: a randomized, double-blind, placebo controlled trial.
MedLine Citation:
PMID:  23803341     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Valeria Cohran; Amy Cassedy; Andre Hawkins; Judy Bean; James Heubi
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of pediatric rehabilitation medicine     Volume:  6     ISSN:  1875-8894     ISO Abbreviation:  J Pediatr Rehabil Med     Publication Date:  2013  
Date Detail:
Created Date:  2013-06-27     Completed Date:  2014-02-04     Revised Date:  2014-05-02    
Medline Journal Info:
Nlm Unique ID:  101490944     Medline TA:  J Pediatr Rehabil Med     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  85-93     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Absorptiometry, Photon
Adolescent
Adult
Alkaline Phosphatase / blood
Biological Markers / 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,  analogs & derivatives*
Female
Humans
Lumbar Vertebrae / drug effects*,  radiography
Male
Osteocalcin / blood
Peptides / blood
Treatment Outcome
Young Adult
Grant Support
ID/Acronym/Agency:
DK T32 07727/DK/NIDDK NIH HHS; RR M01 08084/RR/NCRR NIH HHS; UL1 TR000077/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Biological Markers; 0/Bone Density Conservation Agents; 0/Collagen Type I; 0/Peptides; 0/collagen type I trimeric cross-linked peptide; 104982-03-8/Osteocalcin; 105462-24-6/risedronic acid; EC 3.1.3.1/Alkaline Phosphatase; M2F465ROXU/Etidronic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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