Boonen Steven, Marin Fernando, Mellstrom Dan, Xie Li, Desaiah Durisala, Krege John H, Rosen Clifford J
Leuven University Center for Metabolic Bone Diseases and Division of Geriatric Medicine, Katholieke Universiteit Leuven, Herestraat 49, B-3000 Leuven, Belgium.
J Am Geriatr Soc. 2006 May;54(5):782-9. doi: 10.1111/j.1532-5415.2006.00695.x.
To assess the safety and efficacy of teriparatide in patients aged 75 and older and compare these findings with those of women younger than 75 using data from the Fracture Prevention Trial (FPT).
The FPT was a randomized, multicenter, double-blind, placebo-controlled study.
The FPT multicenter international study.
Postmenopausal women aged 42 to 86 were randomized to placebo (N=544) or teriparatide 20 mug (N=541) by daily self-injection for a median of 19 months. Patients received daily oral supplements of 1,000 mg calcium and 400 to 1,200 IU vitamin D. For this analysis, subgroups were defined according to patient age younger than 75 (N=841) and 75 and older (N=244).
The effects of teriparatide on bone mineral density (BMD) of the lumbar spine and femoral neck; the incidence of new vertebral and new nonvertebral fragility fractures; bone turnover markers, including bone-specific alkaline phosphatase; and urinary deoxypyridinoline corrected for creatinine clearance, as well as the safety of teriparatide, were investigated.
There were no significant treatment-by-age interactions for the bone turnover markers, femoral neck BMD, vertebral fractures, nonvertebral fragility fractures, height loss, hyperuricemia, or hypercalcemia. A significant treatment-by-age interaction for lumbar spine BMD (P=.08) was due to an increase in BMD observed in the placebo group aged 75 and older. There were no treatment-by-age interactions for important treatment-emergent adverse events (TEAEs), including back pain, nausea, leg cramps, and dizziness. The most important TEAEs in women aged 80 and older (23 patients from the placebo group and 25 patients from the teriparatide group) were also reviewed; no unexpected TEAEs were found in the patients treated with teriparatide. These results indicate that the clinical effects of teriparatide were consistent in the older and younger women.
Age does not affect the safety and efficacy of teriparatide in postmenopausal women with osteoporosis.
利用骨折预防试验（FPT）的数据，评估特立帕肽在75岁及以上患者中的安全性和有效性，并将这些结果与75岁以下女性的结果进行比较。
FPT是一项随机、多中心、双盲、安慰剂对照研究。
FPT多中心国际研究。
42至86岁的绝经后女性被随机分为安慰剂组（N = 544）或特立帕肽20μg组（N = 541），通过每日自我注射，中位时间为19个月。患者每日口服补充1000mg钙和400至1200IU维生素D。对于本分析，根据患者年龄分为75岁以下亚组（N = 841）和75岁及以上亚组（N = 244）。
研究了特立帕肽对腰椎和股骨颈骨密度（BMD）的影响；新的椎体和非椎体脆性骨折的发生率；骨转换标志物，包括骨特异性碱性磷酸酶；以及经肌酐清除率校正的尿脱氧吡啶啉，以及特立帕肽的安全性。
在骨转换标志物、股骨颈骨密度、椎体骨折、非椎体脆性骨折、身高降低、高尿酸血症或高钙血症方面，未发现显著的年龄与治疗交互作用。腰椎骨密度存在显著的年龄与治疗交互作用（P = 0.08），这是由于75岁及以上安慰剂组骨密度增加所致。在包括背痛、恶心、腿部痉挛和头晕在内的重要治疗突发不良事件（TEAE）方面，未发现年龄与治疗交互作用。还对80岁及以上女性（安慰剂组23例患者，特立帕肽组25例患者）中最重要的TEAE进行了审查；在接受特立帕肽治疗的患者中未发现意外的TEAE。这些结果表明，特立帕肽在老年和年轻女性中的临床效果是一致的。
年龄不影响特立帕肽在绝经后骨质疏松症女性中的安全性和有效性。
