Section of Health Sciences, Department of Movement, Human and Health Sciences, University "Foro Italico", Piazza Lauro de Bosis, 6, 00135, Rome, Italy.
Section of Medical Pathophysiology, Endocrinology and Nutrition, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
J Endocrinol Invest. 2017 Dec;40(12):1321-1326. doi: 10.1007/s40618-017-0701-3. Epub 2017 Jun 6.
Persistence is commonly considered a key factor for the successful management of osteoporosis and fragility fractures. Denosumab is the first biologic agent developed for the treatment of osteoporosis with satisfying data regarding the persistence with this therapy.
The purpose of this multicenter observational real practice study was to evaluate the persistence with denosumab treatment in post-menopausal women affected by osteoporosis.
MATERIAL/SUBJECTS AND METHODS: Women were recruited in four specialized centers for the management of osteoporosis in North, Center and South of Italy. We included women with a diagnosis of post-menopausal osteoporosis, aged >50 years, able to obtain a prescription according to the Italian reimbursement criteria in force during the study period for anti-osteoporotic pharmacological treatment. They initiated a treatment with subcutaneous denosumab (Prolia) 60 mg/every 6 months between November 2011 and May 2016. Women who had received aromatase inhibitors were excluded. Patients were assessed at baseline and every 6 months for all treatment length. Persistence data were evaluated for a total of 36 months.
Eight hundred seventy women were enrolled; mean aged 70 years, with a mean body mass index of 24.8 ± 4.1 kg/m. At the Dual-energy X-ray absorptiometry assessment, the mean lumbar spine T-score was -2.76 ± 1.14 standard deviations (SD) and the mean femoral neck T-score was -2.49 ± 0.80 SD. During the study, the total persistence was 91.4%. Total dropouts were 75 (8.6%), higher within the initial 6-month period of treatment.
Persistence to denosumab treatment in our observational real practice study was very high. These results suggest that factors such as frequency of visits, pharmacological schedule, and opportunity to call the doctor might play an important role in the persistence and adherence to treatment to obtain maximum therapeutic effect and avoid further fragility fractures.
持续性通常被认为是成功治疗骨质疏松症和脆性骨折的关键因素。地舒单抗是第一种用于治疗骨质疏松症的生物制剂，其治疗的持续性数据令人满意。
本多中心观察性真实实践研究的目的是评估骨质疏松症绝经后妇女对地舒单抗治疗的持续性。
材料/受试者和方法：我们在意大利北部、中部和南部的四个专门的骨质疏松症管理中心招募了女性。我们纳入了诊断为绝经后骨质疏松症、年龄>50 岁的女性，她们能够根据研究期间意大利现行的抗骨质疏松药物治疗报销标准获得处方。她们开始接受皮下注射地舒单抗（普罗力）60mg/每 6 个月治疗，治疗时间为 2011 年 11 月至 2016 年 5 月。排除接受芳香化酶抑制剂治疗的患者。所有治疗期间，患者均在基线和每 6 个月进行评估。评估了 36 个月的持续性数据。
共纳入 870 例女性；平均年龄 70 岁，平均体重指数为 24.8±4.1kg/m2。双能 X 线吸收法评估时，腰椎 T 评分平均为-2.76±1.14 个标准差（SD），股骨颈 T 评分平均为-2.49±0.80 SD。在研究期间，总体持续性为 91.4%。总脱落人数为 75 人（8.6%），治疗最初 6 个月内脱落人数更高。
我们的观察性真实实践研究中，地舒单抗治疗的持续性非常高。这些结果表明，就诊频率、药物治疗方案和与医生通话的机会等因素可能在持续性和治疗依从性方面发挥重要作用，以获得最大的治疗效果并避免进一步的脆性骨折。
