Zoledronic acid for the treatment of osteopenia in pediatric Crohn's disease.
BACKGROUND
Pediatric patients with Crohn's disease often have low bone mass (osteopenia) for age. No randomized, placebo-controlled trials using zoledronic acid have ever been performed in this population. The objective of this study was to assess the efficacy of zoledronic acid in children with Crohn's disease and osteopenia.


METHODS
A double-blind, randomized, placebo-controlled design was used. Thirteen adolescents received either a single intravenous dose of zoledronic acid (0.066 mg/kg, max 4 mg, n= 7) or saline placebo (n= 6). The primary outcome was change in lumbar spine bone mineral density (LSBMD) z-score at 6 months. Secondary outcomes included bone markers and adverse events.


RESULTS
At 6 months, the change in LSBMD z-score was significantly higher in the zoledronic acid group compared to placebo (0.7 vs 0.1, P < 0.001). Volumetrically adjusted LSBMD z-score also significantly increased in the treated group. This significant difference persisted until 12 months. With zoledronic acid, urinary C-telopeptide excretion decreased by 50% at 6 months and remained suppressed at 12 months (P= 0.02), but no changes were observed with placebo. Both groups had similar adverse events which included transient fever, arthralgias, and nausea (3/7 treated, 2/6 placebo, P= NS).


CONCLUSIONS
In this study, zoledronic acid demonstrated a significant increase in LSBMD at 6 and 12 months following a well-tolerated infusion.
Division of Endocrinology, Montreal Children's Hospital, McGill University Health Center, Montreal, Quebec, Canada. asbrocchi@gmail.com
Anne Marie
AM
Sbrocchi
Sylviane
S
Forget
Diane
D
Laforte
E Michel
EM
Azouz
Celia
C
Rodd
D000293:Adolescent; D000704:Analysis of Variance; D015519:Bone Density / Q000502:physiology; D001851:Bone Diseases, Metabolic / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D002648:Child; D003424:Crohn Disease / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D004164:Diphosphonates / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D007275:Injections, Intravenous; D008297:Male; D011446:Prospective Studies; D012016:Reference Values; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome; D000077211:Zoledronic Acid
D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid