Department of Clinical, Internal, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.
Department of Experimental Medicine, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.
Nutrients. 2024 Jun 3;16(11):1754. doi: 10.3390/nu16111754.
We assessed the long-term (24 months) efficacy and safety of monthly calcifediol (0.266 mg) in the correction and maintenance of total 25(OH)D levels in postmenopausal women with basal values <30 ng/mL.
We initially enrolled 45 consecutive patients during the period September 2019-September 2020. After an initial visit, patients were instructed to return at 3, 6, 9, 12 and 24 months for measuring serum total 25(OH)D, ionised calcium, creatinine and isoenzyme of alkaline phosphatase (bALP). Here, we report only the per-protocol analysis, because the COVID-19 pandemic precluded adherence to the scheduled visits for some patients.
The patients' mean age was 62.4 ± 9.0 years. Mean basal 25(OH)D levels were 20.5 ± 5.3 ng/mL. There was a continuous increase of mean 25(OH)D values ( for trend < 0.001). However, mean values at month 24 (36.7 ± 15.9) were not significantly different in respect to values at month 12 (41.2 ± 11.18). At 24 months, only 1 out 19 patients had a value <20 ng/mL. There was a significant decrease with time of mean values of bALP ( < 0.0216), with no significant changes between 12 and 24 months. No significant changes were observed as far as ionised calcium or creatinine were concerned.
The long-term administration of calcifediol maintains stable and sustained 25(OH)D concentrations, with no safety concerns.
我们评估了每月给予骨化二醇（0.266mg）治疗 24 个月对基础值<30ng/ml 的绝经后妇女总 25（OH）D 水平的纠正和维持的长期（24 个月）疗效和安全性。
我们在 2019 年 9 月至 2020 年 9 月期间最初连续纳入了 45 名患者。初始就诊后，患者被指示在 3、6、9、12 和 24 个月时返回以测量血清总 25（OH）D、离子钙、肌酐和碱性磷酸酶同工酶（bALP）。在这里，我们仅报告符合方案分析，因为 COVID-19 大流行使一些患者无法按时就诊。
患者的平均年龄为 62.4 ± 9.0 岁。平均基础 25（OH）D 水平为 20.5 ± 5.3ng/ml。平均 25（OH）D 值呈持续增加趋势（趋势<0.001）。然而，第 24 个月的平均值（36.7 ± 15.9）与第 12 个月的平均值（41.2 ± 11.18）无显著差异。在 24 个月时，仅有 1 例患者的 25（OH）D 值<20ng/ml。bALP 的平均值随时间呈显著下降趋势（<0.0216），12 个月和 24 个月之间无显著变化。离子钙或肌酐无显著变化。
长期给予骨化二醇可维持稳定且持续的 25（OH）D 浓度，且无安全性问题。
