Gilfillan C P, Strauss B J S, Rodda C P, Bowden D K, Kean A-M, Obaid M, Crawford B A
Department of Medicine, Frankston Hospital, P.O. Box 52, Frankston, Victoria, 3199, Australia.
Calcif Tissue Int. 2006 Sep;79(3):138-44. doi: 10.1007/s00223-006-0314-x. Epub 2006 Sep 11.
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.
重型β地中海贫血与低骨量和骨折相关。我们进行了一项为期2年的随机对照试验，每3个月静脉注射4毫克唑来膦酸或安慰剂，用于治疗β地中海贫血相关的骨质减少。我们从2所大学医院招募了23名受试者，其腰椎或髋部的T值小于-1.0，23名受试者完成了研究（17名男性，6名女性）。治疗组在基线时的骨矿物质密度（BMD）、年龄、身高、体重和体重指数（BMI）方面无显著差异。在基线、12个月和24个月时，通过双能X线吸收法（DXA）在腰椎、股骨颈、全髋和全身评估BMD。两年后，与安慰剂组相比，治疗组的平均腰椎BMD增加了8.9%（95%CI 2.3-15.5%，P = 0.011），平均股骨颈BMD增加了9.1%（95%CI 5.5-12.7%，P < 0.0001），平均全髋BMD增加了9.6%（95%CI 6.5-12.6%，P < 0.0001），平均全身BMD增加了4.7%（95%CI 2.7-6.8%，P < 0.0001）。在所有四个部位，治疗组从基线到2年的BMD绝对变化和BMD的年化变化率均显著更大。年龄、性别、身高、体重和BMI与治疗效果无相互作用，因此使用未调整的数据。血清总碱性磷酸酶在12个月时下降了45%（P = 0.004），尿脱氧吡啶啉/肌酐比值在3个月时下降了47%（无统计学意义）。我们得出结论，唑来膦酸（4毫克静脉注射，每3个月一次）可抑制β地中海贫血相关骨质减少患者的骨转换并增加BMD。
