A randomized, double-blind, placebo-controlled trial of intravenous zoledronic acid in the treatment of thalassemia-associated osteopenia

Beta-thalassaemia major is associated with low bone mass and fractures. We conducted a 2 year randomized controlled trial of zoledronic acid 4 mg administered intravenously every 3 months or placebo in the treatment of beta-thalassaemia-associated osteopenla. We recruited 23 subjects from 2 universi...

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Bibliographic Details
Published in:Calcified tissue international 2006-09, Vol.79 (3), p.138-144
Main Authors: Gilfillan, C P, Strauss, B J S, Rodda, C P, Bowden, D K, Kean, A-M, Obaid, M, Crawford, B A
Format: Article
Language:English
Subjects:
Acids
Adolescent
Adult
Alkaline Phosphatase - blood
Alkaline Phosphatase - drug effects
beta-Thalassemia - complications
Bone density
Bone Density - drug effects
Bone Density Conservation Agents - administration & dosage
Bone Diseases, Metabolic - etiology
Bone Diseases, Metabolic - prevention & control
Clinical trials
Diphosphonates - administration & dosage
Double-Blind Method
Female
Humans
Imidazoles - administration & dosage
Male
Medical treatment
Osteoporosis
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Summary:Beta-thalassaemia major is associated with low bone mass and fractures. We conducted a 2 year randomized controlled trial of zoledronic acid 4 mg administered intravenously every 3 months or placebo in the treatment of beta-thalassaemia-associated osteopenla. We recruited 23 subjects from 2 university hospitals with a T score of less than -1.0 at either the lumbar spine or hip, and 23 subjects completed the study (17 M, 6 F). Treatment groups did not differ significantly with respect to bone mineral density (BMD), age, height, weight and body mass index (BMI) at baseline. BMD was assessed at baseline, 12 months and 24 months by dual-energy X-ray absorptiometry (DXA) at the lumbar spine, femoral reek, total hip and total body. After two years average lumbar spine BMD was 8.9% greater (95%CI 2.3-15.5%, P = 0.011), average femoral neck BMD was 9.1% greater (95%CI 5.5-12.7%, P < 0.0001), average total hip BMD was 9.6% greater (95%CI 6.5-12.6%, P < 0.0001) and average total body BMD was 4.7% greater (95%CI 2.7-6.8%, P < 0.0001) in the treated group compared to placebo. The absolute change in BMD from baseline to 2 years and the annualized rate of change of BMD was significantly greater in treated patients at all four sites. Age, gender, height, weight and BMI did not interact with the effect of treatment and so unadjusted data was used. The serum total ALP decreased 45% by 12 months (P = 0.004) and urinary deoxypyridinoline/creatinine ratio decreased 47% by 3 months (NS). We conclude that zoledronic acid (4 mg i.v. 3 monthly) suppresses bone turnover and increases BMD in beta-thalassaemia-associated osteopenia.
ISSN:0171-967X
1432-0827
DOI:10.1007/s00223-006-0314-x