ORTHO TRI CYCLEN ON BIOCHEM MARKERS OF BONE METAB IN HYPOTHALAMIC AMENORRHEA

正三环素对下丘脑闭经骨代谢生化标志物的影响

• 批准号: 6265461
• 负责人: STEVEN K. GRINSPOON
• 金额: $ 0.06万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265461
• 关键词: amenorrhea; biomarker; bone metabolism; clinical research; endocrine disorder; endocrine pharmacology; female; human subject; hypothalamus; oral contraceptives; osteopenia

The objective of this study is to evaluate the effect of ORTHO TRI-CYCLEN on the biochemical markers of bone resporption (Deoxypyrodinoline, N-telopeptide) and formation (Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen of Type I Propeptide (P-I-CP) in women with hypothalamic amenorrhea and osteopenia secondary to their condition. A second objective is to evaluate the effect of ORTHO TRI-CYCLEN on congnitive function. The first phase of the protocol is a three month randomized, placebo-controlled prospective study of the effects of oral contraceptives on bone turnover in women with hypothalamic amenorrhea. The primary endpoints of this study are bone resorption markers (N-telopeptide and deoxypyridinoline) and bone formation markers (osteocalcin, bone specific alkaline phosphatase and PICP). Secondary endpoints include include cognitive function testing, weight and body composition, as measured by skin fold analysis. The second phase of this protocol is a nine month open label extension of the above protocol in which all subjects who wish to continue receive oral contraceptives. The primary endpoint is the effect of oral contraceptives on bone density as measured by Dual Xray Absorpiometry (DXA).

本研究的目的是评估 ORTHO TRI-CYCLEN 对患有下丘脑闭经和继发性骨质减少的女性骨再吸收（脱氧吡咯啉、N-端肽）和形成（骨特异性碱性磷酸酶、骨钙素、I 型前胶原原肽 (P-I-CP)）生化标志物的影响。 第二个目标是评估 ORTHO TRI-CYCLEN 对认知功能的影响。该方案的第一阶段是一项为期三个月的随机、安慰剂对照前瞻性研究，研究口服避孕药对下丘脑闭经女性骨转换的影响。 本研究的主要终点是骨吸收标志物（N-端肽和脱氧吡啶啉）和骨形成标志物 （骨钙素、骨特异性碱性磷酸酶和 PICP）。 次要终点包括认知功能测试、体重和身体成分（通过皮肤褶皱分析测量）。 该方案的第二阶段是上述方案的九个月开放标签扩展，其中所有希望继续接受口服避孕药的受试者。 主要终点是通过双 X 射线测量口服避孕药对骨密度的影响 吸收测定法 (DXA)。