Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research.
Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research.
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DOI：
10.1002/jbmr.2708
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发表时间：
2016-01
期刊：
影响因子：
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通讯作者：
Sellmeyer DE
中科院分区：
文献类型：
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作者：
Adler RA;El-Hajj Fuleihan G;Bauer DC;Camacho PM;Clarke BL;Clines GA;Compston JE;Drake MT;Edwards BJ;Favus MJ;Greenspan SL;McKinney R Jr;Pignolo RJ;Sellmeyer DE
双膦酸盐（BPs）是骨质疏松症最常用的药物，但最佳治疗时间尚不清楚。本ASBMR报告从风险受益角度提供了BP治疗持续时间指南。两项试验为长期使用BP提供了证据。在骨折干预试验长期扩展（FLEX）中，接受阿仑膦酸钠治疗10年的绝经后妇女比5年后改用安慰剂的妇女发生临床椎骨骨折的情况更少。在HORIZON扩展研究中，与3年后改用安慰剂的妇女相比，接受6年一次唑来膦酸输注的妇女发生形态学椎骨骨折的情况较少。FLEX的髋关节T评分在−2和−2.5之间，而HORIZON延长部分低于−2.5，这预示着对继续治疗的有益反应。因此，工作组建议口服BP 5年或静脉BP 3年后，应重新评估女性。既往有严重骨折史的女性、治疗中骨折的女性或其他高危人群通常应继续治疗长达10年（口服）或6年（静脉注射），并定期进行风险-获益评估。年龄较大的女性，髋关节T评分低或骨折风险评分高的女性被认为是高风险。下颌骨坏死和非典型股骨骨折的风险随着BP治疗时间的增加而增加，但在高风险患者中，BP降低骨折风险的作用远远超过这些罕见事件。对于BP治疗3-5年后骨折风险不高的女性，可以考虑休药2-3年，并定期重新评估。为长期BP使用提供的算法基于大多数白人绝经后女性的有限证据，仅用于椎体骨折复位。它可能适用于男性和糖皮质激素诱导的骨质疏松症患者，但有一些调整。未来的骨质疏松症试验不太可能为制定明确的建议提供数据。
Bisphosphonates (BPs) are the most commonly used medications for osteoporosis, but optimal duration of therapy is unknown. This ASBMR report provides guidance on BP therapy duration with a risk benefit perspective. Two trials provided evidence for long-term BP use. In the Fracture Intervention Trial Long-term Extension (FLEX), postmenopausal women receiving alendronate for 10 years had fewer clinical vertebral fractures than those switched to placebo after 5 years. In the HORIZON extension, women who received 6 annual infusions of zoledronic acid had fewer morphometric vertebral fractures compared with those switched to placebo after 3 years. Low hip T-score between −2 and −2.5 in FLEX and below −2.5 in HORIZON extension predicted a beneficial response to continued therapy. Hence, the Task Force suggests that after 5 years of oral BP or 3 years of intravenous BP, women should be reassessed. Women with previous major osteoporotic fracture, those who fracture on therapy, or others at high risk should generally continue therapy for up to 10 years (oral) or 6 years (intravenous), with periodic risk-benefit evaluation. Older women, those with a low hip T-score or high fracture risk score are considered high risk. The risk of osteonecrosis of the jaw and atypical femoral fracture increases with BP therapy duration, but such rare events are far outweighed by fracture risk reduction with BPs in high risk patients. For women not at high fracture risk after 3–5 years of BP treatment, a drug holiday of 2–3 years can be considered, with periodic reassessment. The algorithm provided for long term BP use is based on limited evidence in mostly Caucasian postmenopausal women and only for vertebral fracture reduction. It is probably applicable to men and patients with glucocorticoid-induced osteoporosis, with some adaptations. It is unlikely that future osteoporosis trials will provide data for formulating definitive recommendations.