Department of Orthopaedic and Trauma Surgery, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland.
Department of Interventional Radiology, University Hospital Basel, Petersgraben 4, 4031, Basel, Switzerland.
Arch Orthop Trauma Surg. 2020 Mar;140(3):321-329. doi: 10.1007/s00402-019-03241-4. Epub 2019 Jul 22.
A recent randomized controlled trial has reported full patient compliance and no adverse events from therapy with parathyroid hormone (PTH) for osteoporosis and accelerated healing of fragility fractures of the pelvis. The purpose of the presented study was to evaluate if similar results can be achieved with comprehensive PTH therapy in routine clinical practice. We hypothesised that patients' burden of PTH therapy is underestimated in the literature.
Osteoanabolic PTH therapy was recommended to 79 patients suffering from an acute fragility fracture of the pelvis (FFP). Case finding, initiation of therapy and follow-up were performed by a fracture liaison service team. Primary outcome was PTH initiation rate. Secondary outcomes were implementation rate of alternative antiresorptive pharmaceutical therapy for osteoporosis and participation rate in a bone metabolic workup. Adverse events and effects potentially related to the therapy with bone-active drugs were documented as exploratory outcomes.
Osteoanabolic PTH therapy as suggested was accepted by 32%, whereas antiresorptive therapy was implemented in another 14% of the patients. DEXA scans were available in 38% of the patients (+ 27% when compared to baseline). A bone-specific laboratory analysis was done in 18 patients, uncovering 7 pathological findings. Two patients terminated PTH therapy early because of side effects.
The experiences with PTH therapy in FFP patients with respect to, implementation rate, frequency of side effects and of pathological findings in laboratory controls as reported from a previous RCT could not be reproduced in routine clinical practice.
最近一项随机对照试验报告称,甲状旁腺激素(PTH)治疗骨质疏松症和加速骨盆脆性骨折愈合的患者完全依从治疗,且无不良反应。本研究的目的是评估在常规临床实践中,全面的 PTH 治疗是否能取得类似的结果。我们假设文献中对 PTH 治疗的患者负担估计不足。
向 79 名急性骨盆脆性骨折(FFP)患者推荐使用成骨 PTH 治疗。病例发现、治疗开始和随访由骨折联络服务团队进行。主要结局是 PTH 起始率。次要结局是替代抗吸收性骨质疏松症药物治疗的实施率和参与骨代谢评估的比例。记录潜在与骨活性药物治疗相关的不良事件和影响作为探索性结局。
接受建议的成骨 PTH 治疗的患者占 32%,而另 14%的患者接受了抗吸收性治疗。38%的患者进行了 DEXA 扫描(与基线相比增加了 27%)。对 18 名患者进行了骨特异性实验室分析,发现 7 种病理发现。两名患者因副作用提前终止 PTH 治疗。
在常规临床实践中,无法重现之前 RCT 中报告的 FFP 患者接受 PTH 治疗的经验,包括实施率、副作用频率和实验室控制的病理发现。