背景:育龄妇女在月经周期中经历女性类固醇激素17β-雌二醇和孕酮的周期性变化,某些激素避孕药会减弱这种变化。雌激素在性发育和生殖中起主要作用,但对骨骼具有非生殖作用,肌肉,和筋膜组织(即,韧带和肌腱),这可能会影响受伤风险和身体表现。
目的:这项研究的目的是了解月经周期和激素避孕药的使用对骨骼和钙代谢的影响,肌肉骨骼健康和表现。
方法:将招募总共5组身体活跃的女性(18-40岁)参加:非激素避孕药使用者(n=20);联合口服避孕药(COCP)使用者(n=20);激素植入使用者(n=20);激素宫内系统使用者(n=20);激素注射使用者(n=20)。参与者必须使用COCP和植入物至少1年,使用子宫内系统和注射至少2年。将收集首次尿液样本和禁食血液样本,用于钙和骨代谢的生化分析,荷尔蒙,和代谢标志物。将使用等距测力计测量膝关节伸肌和屈肌强度,和下肢肌腱和刚度,tone,弹性将使用Myoton设备进行测量。将使用单腿下降来评估功能运动,以评估额平面投影角度和单腿负荷的定性评估。骨密度和宏观和微观结构将使用超声波测量,双能X射线吸收法,和高分辨率外周定量计算机断层扫描。骨架材料特性将根据参考点压痕进行估计,在胫骨内侧骨干的平坦表面上进行。身体成分将通过双能X射线吸收法评估。激素避孕组之间结果测量的差异将在协方差的单向组间分析中进行分析。在eumenorrhic组中,月经周期对结局指标的影响将使用线性混合效应模型进行评估.在COCP组中,将使用配对样本双尾t检验分析2个时间点的差异。
结果:该研究于2020年1月获得资助,数据收集于2022年1月开始,预计数据收集完成日期为2024年8月。在提交手稿时同意的参与者人数为66。预计所有数据分析将在2024年底前完成并公布结果。
结论:了解月经周期和激素避孕对肌肉骨骼健康和表现的影响将为身体活跃的女性选择避孕方法提供信息,以控制伤害风险。
背景:ClinicalTrials.govNCT05587920;https://classic.clinicaltrials.gov/ct2/show/NCT05587920.
■DERR1-10.2196/50542。
BACKGROUND: Women of reproductive age experience cyclical variation in the female sex steroid hormones 17β-estradiol and progesterone during the menstrual cycle that is attenuated by some hormonal contraceptives. Estrogens perform a primary function in sexual development and reproduction but have nonreproductive effects on bone, muscle, and sinew tissues (ie, ligaments and tendons), which may influence injury risk and physical performance.
OBJECTIVE: The purpose of the study is to understand the effect of the menstrual cycle and hormonal contraceptive use on bone and calcium metabolism, and musculoskeletal health and performance.
METHODS: A total of 5 cohorts of physically active women (aged 18-40 years) will be recruited to participate: eumenorrheic, nonhormonal contraceptive users (n=20); combined oral contraceptive pill (COCP) users (n=20); hormonal implant users (n=20); hormonal intrauterine system users (n=20); and hormonal injection users (n=20). Participants must have been using the COCP and implant for at least 1 year and the intrauterine system and injection for at least 2 years. First-void urine samples and fasted blood samples will be collected for biochemical analysis of calcium and bone metabolism, hormones, and metabolic markers. Knee extensor and flexor strength will be measured using an isometric dynamometer, and lower limb tendon and stiffness, tone, and elasticity will be measured using a Myoton device. Functional movement will be assessed using a single-leg drop to assess the frontal plane projection angle and the qualitative assessment of single leg loading. Bone density and macro- and microstructure will be measured using ultrasound, dual-energy x-ray absorptiometry, and high-resolution peripheral quantitative computed tomography. Skeletal material properties will be estimated from reference point indentation, performed on the flat surface of the medial tibia diaphysis. Body composition will be assessed by dual-energy x-ray absorptiometry. The differences in outcome measures between the hormonal contraceptive groups will be analyzed in a one-way between-group analysis of covariance. Within the eumenorrheic group, the influence of the menstrual cycle on outcome measures will be assessed using a linear mixed effects model. Within the COCP group, differences across 2 time points will be analyzed using the paired-samples 2-tailed t test.
RESULTS: The research was funded in January 2020, and data collection started in January 2022, with a projected data collection completion date of August 2024. The number of participants who have consented at the point of manuscript submission is 66. It is expected that all data analysis will be completed and results published by the end of 2024.
CONCLUSIONS: Understanding the effects of the menstrual cycle and hormonal contraception on musculoskeletal health and performance will inform contraceptive choices for physically active women to manage injury risk.
BACKGROUND: ClinicalTrials.gov NCT05587920; https://classic.clinicaltrials.gov/ct2/show/NCT05587920.
UNASSIGNED: DERR1-10.2196/50542.