Kim So-Young, Zhang Meng, Bockman Richard
Division of Endocrinology and Metabolism, New York-Presbyterian Hospital/Weill Cornell Medical College, New York, NY 10065 USA.
Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021 USA.
HSS J. 2017 Jul;13(2):171-177. doi: 10.1007/s11420-016-9537-1. Epub 2017 Feb 1.
A review of data from large clinical trials reported more than 90% of subjects significantly improved their bone mineral density (BMD) at the lumbar spine (LS) with teriparatide (TPTD) (bone 39:1268-1275, 1). However, our clinical experience suggests that many patients may be non-responders, raising questions as to the true efficacy of TPTD in improving BMD in osteoporotic patients.
QUESTIONS/PURPOSES: The purpose of the study is to determine the rate of improvement in BMD following 18-24 months of teriparatide (TPTD) in patients with osteoporosis within an orthopedic hospital setting.
This is a retrospective chart review of patients with osteoporosis who completed 18-24 months of TPTD therapy. The primary endpoint was the change in BMD at lumbar spine (LS) and hip-femoral neck (FN) and total hip (TH) following treatment. Secondary endpoints included the effect of prior bisphosphonate therapy, age, body mass index (BMI) and family history of fracture on BMD response, and the changes in bone-specific markers during active treatment.
Seventy-eight women and men with mean T-scores at the LS = -2.63 met the inclusion criteria. The overall group showed a 10.7% increase in LS-BMD after 24 months of TPTD. Eighty-three percent were considered responders defined as ≥3.0% increase in LS-BMD. Non-responders (16.7%) had mean LS-BMD change = -1.41%. No difference in baseline vitamin D, calcium, creatinine, BMI, age, gender, prior fracture history, or bisphosphonate use was observed between responders and non-responders. No consistent pattern of change in measures of bone markers was noted between responders and non-responders.
Eighty-three percent of patients with osteoporosis showed a >3% increase in BMD after TPTD treatment. Baseline parameters, prior bisphosphonate therapy, and the changes in bone markers showed no correlation with final BMD outcome.
对大型临床试验数据的回顾报告称，超过90%的受试者使用特立帕肽（TPTD）后腰椎（LS）骨密度（BMD）显著改善（《骨与矿物质研究杂志》39:1268 - 1275, 1）。然而，我们的临床经验表明，许多患者可能无反应，这引发了关于TPTD在改善骨质疏松症患者骨密度方面真正疗效的疑问。
问题/目的：本研究的目的是确定在骨科医院环境中，骨质疏松症患者接受18 - 24个月特立帕肽（TPTD）治疗后骨密度的改善率。
这是一项对完成18 - 24个月TPTD治疗的骨质疏松症患者的回顾性病历审查。主要终点是治疗后腰椎（LS）、股骨颈（FN）和全髋（TH）的骨密度变化。次要终点包括既往双膦酸盐治疗、年龄、体重指数（BMI）和骨折家族史对骨密度反应的影响，以及在积极治疗期间骨特异性标志物的变化。
78名腰椎平均T值为 - 2.63的女性和男性符合纳入标准。在接受TPTD治疗24个月后，总体组的腰椎骨密度增加了10.7%。83%的患者被视为有反应者，定义为腰椎骨密度增加≥3.0%。无反应者（16.7%）的腰椎骨密度平均变化为 - 1.41%。在有反应者和无反应者之间，未观察到基线维生素D、钙、肌酐、BMI、年龄、性别、既往骨折史或双膦酸盐使用情况的差异。在有反应者和无反应者之间，未发现骨标志物测量值的一致变化模式。
83%的骨质疏松症患者在接受TPTD治疗后骨密度增加>3%。基线参数、既往双膦酸盐治疗以及骨标志物的变化与最终骨密度结果无关。
