BACKGROUND AND PURPOSE Uncemented total hip arthroplasty (THA) is associated with periprosthetic bone loss. In a secondary outcome analysis from a randomized controlled trial, we studied whether denosumab can prevent loss of acetabular periprosthetic bone mineral density (pBMD) in patients who received a trabecular metal cup during uncemented THA. PATIENTS AND METHODS 64 patients (aged 35-65 years) with unilateral osteoarthritis of the hip were randomized to 2 subcutaneous injections with denosumab or placebo, given 1-3 days post-surgery and 6 months post-surgery. Acetabular pBMD was measured in 5 regions of interest (ROIs) by dual-energy X-ray absorptiometry. Serum markers for bone metabolism were analyzed. Periprosthetic osteoblastic activity, measured as standardized uptake values (SUVs) by [18F] positron emission tomography/computed tomography, was evaluated in 32 of the 64 study patients. RESULTS After 12 months, patients treated with denosumab had higher pBMD compared with the placebo-treated patients in 4 of 5 ROIs and in sum of ROIs 1-5. After 24 months, the effect on pBMD for patients treated with denosumab declined. Serum markers declined pronouncedly up to 12 months in patients treated with denosumab, but rebounded above baseline levels after 24 months. Patients treated with denosumab had statistically significantly lower SUVs in all ROIs, except ROI 5, after 6 months. INTERPRETATION Based on this exploratory analysis of secondary endpoints the application of denosumab seems associated with preserved acetabular pBMD, reduced bone metabolism and attenuated periprosthetic osteoblastic activity. However, given the known rebound affects after discontinuation of denosumab treatment, these effects cannot be expected to persist. If prolonged treatment or shift to other regimes would be beneficial to reduce the risk of cup loosening is yet to be investigated.

中文翻译：

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Denosumab 可预防非骨水泥杯周围的髋臼骨丢失：随机对照试验中的次要结果分析。

背景和目的非骨水泥型全髋关节置换术 (THA) 与假体周围骨丢失有关。在一项随机对照试验的次要结果分析中，我们研究了狄诺塞麦是否可以防止在非骨水泥 THA 期间接受小梁金属杯的患者的髋臼假体周围骨密度 (pBMD) 损失。患者和方法 64 名患有单侧髋关节骨关节炎的患者（年龄 35-65 岁）被随机分配到术后 1-3 天和术后 6 个月进行 2 次地诺单抗或安慰剂皮下注射。通过双能 X 射线吸收测定法在 5 个感兴趣区域 (ROI) 中测量髋臼 pBMD。分析了骨代谢的血清标志物。假体周围成骨细胞活动，通过 [18F] 正电子发射断层扫描/计算机断层扫描作为标准摄取值 (SUV) 测量，在 64 名研究患者中的 32 名中进行了评估。结果 12 个月后，在 5 个 ROIs 中有 4 个和 ROIs 1-5 的总和中，与接受安慰剂治疗的患者相比，接受狄诺塞麦治疗的患者具有更高的 pBMD。24 个月后，地诺单抗治疗患者对 pBMD 的影响下降。在接受地诺单抗治疗的患者中，血清标志物在长达 12 个月时显着下降，但在 24 个月后反弹至基线水平以上。6 个月后，接受狄诺塞麦治疗的患者在所有 ROI 中的 SUV 具有统计学意义的显着降低，ROI 5 除外。解释 基于对次要终点的探索性分析，狄诺塞麦的应用似乎与保留的髋臼 pBMD 有关，骨代谢减少，假体周围成骨细胞活动减弱。然而，考虑到狄诺塞麦治疗停止后已知的反弹影响，预计这些影响不会持续。延长治疗或转向其他方案是否有益于降低臼杯松动的风险尚待研究。