Pinto-Bonilla Rosa, Baeza-Noci José, Blanco Clara Casado, Gumbau Guillermo Javier Valls, Fernández Rubén Juarez, Pascual-Pastor María, Magamón Blanca García, Lamothe Blanca Panero, Pastor Carmen Moragues, Aviñó Rafael Izquierdo, Aguilar Eva García, Saz-Leal Paula
Servicio de Traumatología, Hospital Vithas Valencia Consuelo, Spain.
Servicio de Rehabilitación, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Bone Rep. 2024 Jul 26;22:101796. doi: 10.1016/j.bonr.2024.101796. eCollection 2024 Sep.
Treatment of calcium (Ca) and vitamin D (VD) deficiency (VDD) is crucial for health, especially in bone conditions, such as low bone mineral density (BMD) and osteoporosis. Despite updates in clinical guideline recommendations, no studies have evaluated the efficacy and safety of administering 2000 IU of cholecalciferol combined with calcium. Thus, the main objective of this study was to evaluate VD levels following treatment with Ca 600 mg/ cholecalciferol 2000 IU in real-life clinical practice.
This multicenter, retrospective, observational study included 302 adult patients receiving Ca 600 mg/D3 2000 IU orodispersible tablets, daily for ≥24 weeks. The primary outcome was 25-hydroxivitamin D [25(OH)D] serum levels following treatment. Key secondary outcomes included changes in serum 25(OH)D levels and other bone metabolism (BM) parameters, safety and tolerability. The protocol was approved by a Research Ethics Committee.
285 patients were evaluated (mean age [SD]: 67.4 [12.6] years old; 88.4 % women; basal serum 25(OH)D: 20.0 [8.6] ng/mL); 80.7 % reported previous history of osteoporosis/low BMD (osteopenia) and 37.2 % had received other Ca/VD prior to start study treatment. Median treatment duration was 38.5 weeks [range 24.0-82.4]. Overall, 94.4 % of patients increased serum 25(OH)D following treatment to a mean of 36.3 [11.8] ng/mL ( < 0.001 baseline). Patients with basal VDD, significantly increased serum 25(OH)D to a mean over 30 ng/mL; no significant change found in repleted patients (basal 25(OH)D level ≥ 30 ng/mL). PTH was significantly reduced after treatment, with no clinically relevant effect on serum Ca or phosphate. Three non-serious treatment-emergent adverse events were reported. A post-hoc analysis on osteoporotic patients revealed virtually identical results in this population.
Treatment with Ca 600 mg/cholecalciferol 2000 IU for at least 24 weeks is effective and safe, especially in osteoporosis. Patients with VDD significantly increase plasma 25(OH)D to optimal range for bone health, with no clinically relevant changes on other bone metabolism parameters other than reducing secondary hyperparathyroidism. The magnitude of 25(OH)D increase directly correlates with the severity of VDD, with no effect in basally repleted patients.
钙（Ca）和维生素D（VD）缺乏（VDD）的治疗对健康至关重要，尤其是在骨骼疾病中，如低骨矿物质密度（BMD）和骨质疏松症。尽管临床指南建议有所更新，但尚无研究评估给予2000国际单位胆钙化醇联合钙的疗效和安全性。因此，本研究的主要目的是在现实临床实践中评估服用600毫克钙/2000国际单位胆钙化醇治疗后的VD水平。
本多中心、回顾性、观察性研究纳入了302例成年患者，他们每天服用600毫克钙/2000国际单位D3口腔崩解片，持续≥24周。主要结局是治疗后血清25-羟维生素D[25(OH)D]水平。关键次要结局包括血清25(OH)D水平和其他骨代谢（BM）参数的变化、安全性和耐受性。该方案已获得研究伦理委员会的批准。
对285例患者进行了评估（平均年龄[标准差]：67.4[12.6]岁；88.4%为女性；基础血清25(OH)D：20.0[8.6]纳克/毫升）；80.7%报告有骨质疏松症/低BMD（骨质减少）病史，37.2%在开始研究治疗前接受过其他钙/VD治疗。中位治疗持续时间为38.5周[范围24.0 - 82.4]。总体而言，94.4%的患者治疗后血清25(OH)D升高，平均达到36.3[11.8]纳克/毫升（与基线相比P<0.001）。基础VDD患者的血清25(OH)D显著升高至平均超过30纳克/毫升；在VD充足的患者（基础25(OH)D水平≥30纳克/毫升）中未发现显著变化。治疗后甲状旁腺激素（PTH）显著降低，对血清钙或磷无临床相关影响。报告了3例非严重的治疗中出现的不良事件。对骨质疏松症患者的事后分析显示该人群结果几乎相同。
服用600毫克钙/2000国际单位胆钙化醇治疗至少24周是有效且安全的，尤其是在骨质疏松症患者中。VDD患者的血浆25(OH)D显著升高至骨骼健康的最佳范围，除了降低继发性甲状旁腺功能亢进外，对其他骨代谢参数无临床相关变化。25(OH)D升高的幅度与VDD的严重程度直接相关，对基础VD充足的患者无影响。
