The Effect of Zoledronic Acid on the Prevention of Bone Loss in Lymphoma Patients Receiving First-line Therapy

Jason Westin , Fredrick Hagemeister , Michael A. Thompson , Vince D. Cataldo , Bela B. Toth , Perpetua Sanjorjo , Scott Bourgeois , Camilo Jimenez , William A. Murphy , Michelle Fanale , Luis Fayad , Nathan Fowler , Larry Kwak , Peter McLaughlin , Sattva Neelapu , Barbara Pro , Alma Rodriguez , Jatin Shah
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Abstract

Patients with lymphoma are at high risk of osteoporosis. The majority have osteopenia at baseline, and the risk increases when treated with alkylating agents or corticosteroids. We conducted a randomized phase III trial to evaluate the effect of zoledronic acid on bone mineral density (BMD) in patients with lymphoma undergoing chemotherapy.

Full Abstract

Introduction

Osteoporotic bone cannot easily be restored to normal levels of strength; thus, the prevention of bone loss is crucial. Pamidronate can reduce the risk of bone loss and vertebral fractures in patients with lymphoma receiving chemotherapy. Zoledronic acid, a bisphosphonate approximately 100-fold more potent than pamidronate, has not been evaluated in lymphoma patients to date. We conducted a prospective trial to determine whether zoledronic acid reduces the risk of developing osteoporosis in this patient population.

Patients and Methods

All patients with newly diagnosed lymphoma seen at our institution from 2005 to 2009 were evaluated for protocol eligibility. Exclusion criteria included bone fractures, bone mineral density (BMD) T-scores poorer than −2.0, creatinine clearance < 60 mL/min, dental problems, and recent steroid or bisphosphonate use. Patients on study were stratified according to sex and menopausal status. Accrued patients received randomized therapy of either: (1) oral calcium and vitamin D (Ca + D), or (2) Ca + D and 4 mg zoledronic acid intravenously (I.V.) at baseline and at 6 months.

Results

To date, 33 patients have completed the study and have evaluable data. Patient characteristics included 17 men; 4 pre-menopausal women; 12 post-menopausal women; and median age, 62 years (range, 33–80 years). Seventeen patients had mild osteopenia upon enrollment. Patients who received zoledronic acid had stable median T-scores at all locations during the 12-month observation, whereas the T-scores of the control group decreased at every location evaluated (location: L1-4, P = .004; L neck, P = .001; L hip, P = .118; R neck, P = .009; R hip, P = .04).

Conclusion

Treatment with zoledronic acid in patients with newly diagnosed lymphoma prevents the BMD loss commonly seen in this population. Bone mass loss is difficult to restore, thus necessitating effective prevention strategies; additional studies should be conducted to confirm these findings.

唑来膦酸对一线治疗淋巴瘤患者骨质流失的预防作用
淋巴瘤患者是骨质疏松的高危人群。大多数人在基线时骨质减少,当使用烷基化剂或皮质类固醇治疗时,风险增加。我们进行了一项随机III期试验,以评估唑来膦酸对接受化疗的淋巴瘤患者骨密度(BMD)的影响。骨质疏松的骨不容易恢复到正常的强度水平;因此,预防骨质流失至关重要。帕米膦酸盐可以降低淋巴瘤患者接受化疗时骨质流失和椎体骨折的风险。唑来膦酸是一种比帕米膦酸强约100倍的双膦酸盐,迄今尚未对其在淋巴瘤患者中的作用进行评估。我们进行了一项前瞻性试验,以确定唑来膦酸是否能降低这类患者发生骨质疏松症的风险。患者和方法对我院2005 - 2009年间所有新诊断的淋巴瘤患者进行方案适格性评估。排除标准包括骨折、骨密度(BMD) t评分低于- 2.0、肌酐清除率和lt;60 mL/min,牙齿问题,近期使用类固醇或双磷酸盐。研究患者按性别和绝经状态进行分层。累积患者接受随机治疗:(1)口服钙和维生素D (Ca + D),或(2)在基线和6个月时静脉注射Ca + D和4mg唑来膦酸。迄今为止,33名患者完成了研究并获得了可评估的数据。患者特征包括17名男性;绝经前妇女4名;12名绝经后妇女;年龄中位数为62岁(范围33-80岁)。17例患者入组时出现轻度骨质减少。在12个月的观察中,接受唑来膦酸治疗的患者在所有部位的t评分中位数稳定,而对照组的t评分在每个评估部位均下降(位置:L1-4, P = 0.004;L颈,P = .001;左臀,P = 0.118;R颈,P = 0.009;R髋,P = .04)。结论唑来膦酸治疗新诊断的淋巴瘤患者可预防BMD损失。骨量损失难以恢复,因此需要有效的预防策略;应该进行更多的研究来证实这些发现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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