Department of Medical Oncology/Hematology, National Centre for Cancer Care & Research (NCCCR).
Department of Laboratory Medicine and Pathology, Biochemistry Section.
Medicine (Baltimore). 2020 Dec 18;99(51):e23637. doi: 10.1097/MD.0000000000023637.
The main aim of this study is to compare the 2 medications denosumab and zoledronic acid for patients with beta-thalassemia major induced osteoporosis. Patients with B-thalassemia major induced osteoporosis will undergo baseline assessment of the bone densitometry by bone density(DEXA) scan as a standard of care by the radiology department, then a blood test for bone-specific alkaline phosphatase and type-1 collagen telopeptide will be measured by the chemistry laboratory.Patients with B-thalassemia major induced osteoporosis, who are 18 years of age or more and willing to participate in the study will be enrolled after consenting by the primary investigator in hematology outpatient clinics. Patients with osteoporosis will receive 1 of the 2 medications; at the end of the year, DEXA scan will be done to compare the response of the 2 medications. The potential risks include drug-related side effects.The outcome will be measured biochemically by measuring bone-specific alkaline phosphatase and type 1 collagen carboxy telopeptide and radiologically by DEXA scan at baseline and 1 year using Z score.
本研究的主要目的是比较两种药物地舒单抗和唑来膦酸在治疗β地中海贫血导致的骨质疏松症患者中的疗效。β地中海贫血导致的骨质疏松症患者将接受基线骨密度(DEXA)扫描评估,该检查由放射科作为标准护理进行,然后由化学实验室测量骨特异性碱性磷酸酶和 I 型胶原 C 端肽。在血液科门诊经主要研究者同意后,年龄在 18 岁及以上并愿意参加研究的β地中海贫血导致的骨质疏松症患者将被纳入研究。骨质疏松症患者将接受两种药物中的一种治疗,治疗 1 年后,进行 DEXA 扫描以比较两种药物的疗效。潜在风险包括药物相关的副作用。将通过测量基线和 1 年后的骨特异性碱性磷酸酶和 I 型胶原羧基端肽进行生化评估,并使用 DEXA 扫描进行影像学评估,以 Z 评分表示。