Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930, Randers, Denmark.
Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus, Denmark.
Osteoporos Int. 2021 Aug;32(8):1557-1566. doi: 10.1007/s00198-021-05835-4. Epub 2021 Jan 30.
In patients discontinuing ALN after a median of 7.0 years (range 5.0-20.0 years), BMD decreased, and bone turnover markers increased within the premenopausal reference range over 2 years. Increased p-CTX after 3 months was associated with greater bone loss at the hip confirming that maintenance of BMD is dependent on continued suppression of bone turnover.
It is unknown how to monitor patients discontinuing alendronate (ALN) after more than 5 years. We investigated if BTM measured before or during treatment discontinuation with ALN predict bone loss after 1 or 2 years.
PROSA was a cohort study conducted at Aarhus University Hospital including postmenopausal women and men above 50 years treated with ALN ≥ 5 years who had osteopenia at the hip and BMD T-score at the lumbar spine > - 4. ALN was discontinued and BTMs were measured at baseline, months (M) 1, 3, 6, and 12, and DXA was performed at baseline, M6, and M12. We extended the study and measured BTMs and performed DXA at M24. The primary endpoint was if changes in p-CTX at M3 or M6 predict changes in THBMD after 1 year ( Clinicaltrials.gov : NCT03051620).
We enrolled 136 participants discontinuing ALN after a median of 7.0 years (range 5.0-20.0 years) in PROSA and 124 participants in PROSA Extension. There was a significant decrease in LSBMD - 0.74% ± 0.27, THBMD - 2.65% ± 0.39, FNBMD - 2.35% ± 0.33, and trabecular bone score - 0.97% ± 0.35 and an increase in p-CTX by 61.1% ± 4.7 (p < 0.05 for all) after 24 months. Increase in p-CTX at M3 was associated with bone loss at the hip sites at M12 and M24.
In patients discontinuing ALN, BMD decreased significantly and BTMs increased within the reference range over 2 years. An increase in p-CTX after 3 months was associated with greater bone loss at the hip confirming that maintenance of BMD during treatment discontinuation is dependent on continued suppression of bone turnover.
在中位时间为 7.0 年（范围为 5.0-20.0 年）停止使用 ALN 的患者中，BMD 下降，并且在绝经前参考范围内的骨转换标志物在 2 年内增加。3 个月后 p-CTX 的增加与髋部骨丢失的增加相关，这证实了维持 BMD 依赖于持续抑制骨转换。
尚不清楚如何监测停止使用阿仑膦酸钠（ALN）超过 5 年的患者。我们研究了在停止使用 ALN 之前或期间测量的 BTM 是否可以预测 1 或 2 年后的骨丢失。
PROSA 是在奥胡斯大学医院进行的一项队列研究，包括接受 ALN 治疗≥5 年的绝经后妇女和 50 岁以上的男性，他们的髋部有骨量减少，腰椎 BMD T-评分>-4。停止使用 ALN，并在基线、第 1、3、6 和 12 个月测量 BTMs，在基线、第 6 和第 12 个月进行 DXA。我们扩展了研究，并在第 24 个月测量了 BTMs 和进行了 DXA。主要终点是 p-CTX 在第 3 个月或第 6 个月的变化是否预测 1 年后 THBMD 的变化（Clinicaltrials.gov：NCT03051620）。
我们在 PROSA 中纳入了 136 名中位时间为 7.0 年（范围为 5.0-20.0 年）停止使用 ALN 的参与者，并在 PROSA 扩展研究中纳入了 124 名参与者。LSBMD 下降了-0.74%±0.27，THBMD 下降了-2.65%±0.39，FNBMD 下降了-2.35%±0.33，小梁骨评分下降了-0.97%±0.35，p-CTX 增加了 61.1%±4.7（所有指标均 p<0.05）。在 24 个月时，BMD 显著下降，骨转换标志物在绝经前参考范围内增加。3 个月时 p-CTX 的增加与髋部部位的骨丢失相关，在 12 个月和 24 个月时也有同样的情况。
在停止使用 ALN 的患者中，BMD 在 2 年内显著下降，并且 BTMs 在参考范围内增加。3 个月后 p-CTX 的增加与髋部骨丢失相关，证实了在停止治疗期间维持 BMD 依赖于持续抑制骨转换。
