Clinic of Rheumatology, Department Internal Medicine, University Hospital "St. Ivan Rilsky", Medical University-Sofia, 13 "Urvich" Str., 1612, Sofia, Bulgaria.
Clinic of Endocrinology and Metabolic Diseases, Department Internal Medicine, University Hospital Alexandrovska, Medical University-Sofia, 1 G. Sofiyski Str., 1431, Sofia, Bulgaria.
Arch Osteoporos. 2017 Dec 21;13(1):1. doi: 10.1007/s11657-017-0413-5.
Persistence with osteoporosis therapy is critical for fracture risk reduction. This observational study evaluated medication-taking behaviour of women with postmenopausal osteoporosis receiving denosumab or oral ibandronate in real-world clinical practice in Bulgaria. Compared with ibandronate, densoumab was associated with a lower discontinuation rate and greater increases in bone mineral density.
Persistence with osteoporosis therapy is critical for fracture risk reduction and the effectiveness of such treatments may be reduced by low persistence. Alternative therapies such as denosumab may improve persistence. This study aimed to describe medication-taking behaviour in women with osteoporosis, prescribed denosumab or oral ibandronate, in Bulgarian clinical practice.
This retrospective, observational, multicentre chart review (with up to 24 months follow-up) enrolled postmenopausal women initiating 6-monthly denosumab injection or monthly oral ibandronate treatment for osteoporosis between 1 October 2011 and 30 September 2012.
Overall, 441 women were enrolled (224 had initiated denosumab, 217 had initiated ibandronate). At baseline, more women in the denosumab group than in the ibandronate group had a previous fracture (25.5 vs 17.5%; p = 0.043) and past exposure to osteoporosis therapy (19.6 vs 12.0%; p = 0.028). At 24 months, 4.5% of women receiving denosumab had discontinued therapy compared with 56.2% of women receiving ibandronate. Median time to discontinuation was longer in the denosumab group (729 days; interquartile range (IQR), 728.3-729.0) than in the ibandronate group (367 days; IQR, 354.0-484.8; p < 0.001). At 24 months, there were significantly greater changes in BMD T-scores at the lumbar spine (p < 0.001) and femoral neck (p < 0.001) in patients receiving denosumab than in those receiving ibandronate. At 24 months, persistence with denosumab was 98.7%.
This real-world study demonstrates there is a low discontinuation rate and high persistence with denosumab. Denosumab was associated with greater BMD increases than ibandronate, which could reduce fracture risk.
骨质疏松症治疗的持续性对于降低骨折风险至关重要，而低持续性可能会降低此类治疗的效果。替代疗法，如 denosumab，可能会提高持续性。本研究旨在描述在保加利亚临床实践中，接受 denosumab 或口服伊班膦酸盐治疗的骨质疏松症女性的用药行为。
这是一项回顾性、观察性、多中心病历回顾研究（随访时间长达 24 个月），纳入 2011 年 10 月 1 日至 2012 年 9 月 30 日期间开始接受每 6 个月一次 denosumab 注射或每月一次口服伊班膦酸盐治疗骨质疏松症的绝经后女性。
共有 441 名女性入组（224 名接受 denosumab 治疗，217 名接受伊班膦酸盐治疗）。基线时，与伊班膦酸盐组相比，接受 denosumab 治疗的女性中既往骨折（25.5% vs 17.5%；p=0.043）和既往骨质疏松症治疗暴露（19.6% vs 12.0%；p=0.028）的比例更高。24 个月时，接受 denosumab 治疗的女性中，有 4.5%的人停止了治疗，而接受伊班膦酸盐治疗的女性中，有 56.2%的人停止了治疗。denosumab 组的中位停药时间长于伊班膦酸盐组（729 天；四分位间距（IQR），728.3-729.0 比 367 天；IQR，354.0-484.8；p<0.001）。24 个月时，接受 denosumab 治疗的患者腰椎（p<0.001）和股骨颈（p<0.001）的骨密度 T 评分变化明显大于接受伊班膦酸盐治疗的患者。24 个月时，denosumab 的持久性为 98.7%。
这项真实世界研究表明，denosumab 的停药率低，持久性高。与伊班膦酸盐相比，denosumab 可增加骨密度，从而降低骨折风险。
