DEPO PROVERA AND BONE MINERAL DENSITY IN ADOLESCENTS

DEPO PROVERA 与青少年骨矿物质密度

• 批准号: 2679232
• 负责人: BARBARA A. CROMER
• 金额: $ 49.84万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-01 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2679232
• 关键词: adolescence (12-20); age difference; bone density; calcium metabolism; chemoprevention; clinical research; dosage forms; drug adverse effect; estradiol; female; female antifertility drug; hormone therapy; human subject; human therapy evaluation; longitudinal human study; medroxyprogesterone; sex hormones; women's health

DESCRIPTION: (Adapted from Investigator's Abstract) The United States has one of the highest adolescent pregnancy rates among industrialized nations. One of the major contributing factors is inadequate contraception. A very effective contraceptive method is depot-medroxyprogesterone acetate (DMPA) which has become increasingly popular in this age group. Recent research in adults has suggested a negative effect of DMPA on bone mineral density (BMD). With decreased BMD, one's risk increases later for osteoporosis, a major public health problem affecting millions of postmenopausal women every year. Compromised BMD would appear to be a particular concern in adolescents, as they normally accrue up to 40% of their total bone mineral content during this period. In preliminary work, the investigators demonstrated a 3.0% decrease in BMD in adolescent DMPA users over 2 years, compared with a 9.0% increase in untreated controls (p<0.0001). A prospective cohort study of the effects of DMPA on adolescent BMD, which will also include a double-blinded randomized prevention component, is proposed. Bone density in 400 adolescent DMPA initiators will be compared to their baseline values and to that of 300 and 120, oral and barrier contraceptive initiators, respectively, frequency matched on age and race. Bone density will be measured every six months for a maximum of two years. Bone density will also be measured at the time of discontinuation of contraceptive method. To evaluate the protective effects of estrogen on bone density, females in the DMPA treatment arm will be randomly assigned to DMPA with estradiol (n=200) and DMPA without estradiol (n=200). To examine the question of whether age modifies the effect of DMPA on bone density, the investigators will evaluate the age-treatment interaction between DMPA use and bone density among females of varying gynecologic ages. Finally, sex hormone levels and indices of calcium metabolism will be compared among the treatment groups in order to explore the biologic mechanisms underlying BMD changes. The statistical analysis will estimate the effect of DMPA on bone density while taking account of constant treatment discontinuation throughout the study period.

描述：(改编自《调查人员摘要》)美国有一家 在工业化国家中，青少年怀孕率最高。一 造成这一现象的主要因素之一是避孕不足。一个非常好的 有效的避孕方法是醋酸甲羟孕酮(DMPA) 它在这个年龄段变得越来越受欢迎。最近的研究 成年人认为DMPA对骨密度(BMD)有负面影响。 随着BMD的降低，一个人患骨质疏松症的风险增加，骨质疏松症是一种主要的 每年影响数百万绝经后妇女的公共卫生问题。 BMD受损在青少年中似乎是一个特别令人担忧的问题，因为 在此期间，它们通常积累高达其总骨矿含量的40%。 句号。在初步工作中，调查人员显示下降了3.0% 在青少年DMPA使用者中，超过2年的BMD，相比之下， 未经处理的对照组(P&lt；0.0001)。一项前瞻性队列研究 DMPA对青少年骨密度的影响，其中还将包括一项双盲随机 提出了预防组件的概念。400名青少年DMPA的骨密度调查 启动器将与其基准值以及300和 120，分别为口服和屏障避孕启动剂，频率 在年龄和种族上相匹配。骨密度将每六个月测量一次 最多两年。骨密度也将在以下时间测量 停止使用避孕方法。评估其防护效果 雌激素对骨密度的影响，女性在DMPA治疗臂中将 随机分配到含有雌二醇的DMPA组(n=200)和不含雌二醇组的DMPA组 200例。来考察年龄是否会改变DMPA的效果 在骨密度方面，研究人员将评估年龄与治疗的交互作用 在不同妇科年龄的女性中，DMPA的使用与骨密度之间的关系。 最后对性激素水平和钙代谢指标进行比较。 在治疗组之间进行比较，以探讨其生物学机制 潜在的骨密度变化。统计分析将估计 DMPA对骨密度的影响，同时兼顾恒定治疗 在整个研究期间停止。