Ripps Barry A, VanGilder Kelly, Minhas Brijinder, Welford Mayla, Mamish Ziad
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Florida College of Medicine, 5147 North Ninth Avenue, Suite 315, Pensacola, FL 32504, USA.
J Reprod Med. 2003 Oct;48(10):761-6.
To evaluate alendronate as a prophylactic measure against bone mineral density (BMD) loss in reproductive-aged women receiving gonadotropin-releasing hormone agonist (GnRHa) therapy for 6 months.
A randomized, double-blind, placebo-controlled, pilot trial at a university-affiliated community hospital. Subjects were 11 premenopausal women with indications for GnRHa therapy who were randomized to receive alendronate, 10 mg, or placebo, by mouth daily during 6 months of GnRHa use. Both groups received intramuscular depot leuprolide acetate, 3.75 mg every 28 days for a total of 24 weeks. BMD at the lumbar spine and femur was determined by dual energy x-ray absorptiometry at baseline and at the conclusion of treatment. Lipids and urinary N-telopeptide were measured before and during treatment.
Alendronate-exposed subjects experienced a mean gain of 1.0% (P = .35) in lumbar BMD as compared to a significant mean loss in the control group 3.8% (P = .01). Subjects in the placebo group experienced a significant reduction in mean femur BMD of 3.4% (P = .02), while alendronate-exposed subjects had a loss of 0.4% (P = .65). Bone turnover, as evidenced by urinary N-telopeptide, increased over baseline for both groups. Neither group experienced significant changes in lipids during the study period.
Alendronate appears to offer some degree of protection against BMD loss in young women during transient, induced hypoestrogenemia. Alendronate was associated with a gain in lumbar (trabecular) BMD but less than expected from studies of postmenopausal women. With the expectation that young women gain BMD, extending the safe and effective duration of GnRHa therapy in this population may require additional measures.
评估阿仑膦酸钠作为一种预防措施，用于接受促性腺激素释放激素激动剂（GnRHa）治疗6个月的育龄期女性骨矿物质密度（BMD）损失的情况。
在一家大学附属社区医院进行的一项随机、双盲、安慰剂对照的试点试验。研究对象为11名有GnRHa治疗指征的绝经前女性，她们在使用GnRHa的6个月期间被随机分配，每天口服10 mg阿仑膦酸钠或安慰剂。两组均接受每28天一次的3.75 mg醋酸亮丙瑞林缓释微球肌肉注射，共24周。在基线和治疗结束时，通过双能X线吸收法测定腰椎和股骨的骨密度。在治疗前和治疗期间测量血脂和尿N-端肽。
与对照组平均显著降低3.8%（P = .01）相比，接受阿仑膦酸钠治疗的受试者腰椎骨密度平均增加了1.0%（P = .35）。安慰剂组受试者股骨平均骨密度显著降低3.4%（P = .02），而接受阿仑膦酸钠治疗的受试者骨密度降低了0.4%（P = .65）。尿N-端肽表明，两组的骨转换均高于基线水平。在研究期间，两组血脂均无显著变化。
阿仑膦酸钠似乎能在年轻女性短暂性诱导低雌激素血症期间，为骨密度损失提供一定程度的保护。阿仑膦酸钠与腰椎（小梁）骨密度增加有关，但低于绝经后女性研究的预期。鉴于期望年轻女性增加骨密度，在该人群中延长GnRHa治疗的安全有效持续时间可能需要采取额外措施。
