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

本研究的目的是评价奥三环对继发性下丘脑闭经和骨量减少的女性下丘脑闭经和继发性骨量减少的骨吸收生化指标(脱氧吡啶酚、N-端肽)和骨形成生化指标(骨特异性碱性磷酸酶、骨钙素、I型前胶原(P-I-CP))的影响。第二个目标是评估正三环对认知功能的影响。该方案的第一阶段是一项为期三个月的随机、安慰剂对照的前瞻性研究，研究口服避孕药对下丘脑闭经妇女骨转换的影响。本研究的主要终点是骨吸收标记物(N-端肽和脱氧吡啶)和骨形成标记物(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，通过皮肤褶皱分析来衡量。该方案的第二阶段是上述方案的九个月开放标签延长，其中所有希望继续接受口服避孕药的受试者。主要终点是口服避孕药对双X射线吸收测量仪(DXA)测量的骨密度的影响。

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).