Determining Bone Loss and Bone Mineral Density Recovery Following Repeat Pregnancy/Lactation Among HIV Women on ART

确定接受 ART 治疗的 HIV 妇女重复怀孕/哺乳后的骨质流失和骨矿物质密度恢复情况

• 批准号: 9767843
• 负责人: MARY Glenn Fowler
• 金额: $ 51.69万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9767843
• 关键词: 25-hydroxyvitamin D; Affect; Africa; Age; Alcohols; Anti-Retroviral Agents; Attenuated; Biological Markers; Bone Density; Breast Feeding; Calcium; Clinical; Cyclophosphamide; Data; Dual-Energy X-Ray Absorptiometry; Enrollment; Follow-Up Studies; HIV; HIV Seronegativity; Infant; Lactation; Life; Malawi; Measurement; Measures; Mothers; N-terminal; Nevirapine; Osteopenia; Osteoporosis; Pattern; Phosphorus; Postpartum Period; Pregnancy; Pregnant Women; Procollagen; Prophylactic treatment; Randomized; Recording of previous events; Recovery; Regimen; Reporting; Research; Risk; Risk Factors; Serum; Site; Smoking; Specimen; Time; Uganda; Woman; age group; antiretroviral therapy; base; bone; bone health; bone loss; clinical risk; cohort; comparison group; experience; follow-up; parity; pregnant; rate of change

DXA R01 Project Summary The PROMISE 1077BF trial found significantly decreased Bone Mineral Density (BMD) by 18 months post delivery among asymptomatic HIV infected mothers randomized to receive antiretroviral therapy (ART) during extended breastfeeding when compared to mothers whose infants were randomized to receive nevirapine prophylaxis during breastfeeding. Breastfeeding is also associated with transient decreases in BMD but usually followed by BMD recovery. Among HIV infected women, the longer term impact of life time ART with repeat pregnancy/repeat breastfeeding on maternal BMD of HIV infected mothers remains unknown. However our initial findings from PROMISE on BMD decreases seen with ART during breastfeeding raise concerns over a potential increased risk of early osteopenia or osteoporosis when compared to mothers are not HIV infected and not exposed to lifetime ART. Given these PROMISE findings, we propose a longitudinal follow up of BMD changes with repeat pregnancy and extended breastfeeding among HIV infected mothers from the PROMISE trial who are now enrolled in the PROMOTE cohort follow up study at the Blantyre Malawi and the Kampala Uganda site, in order to better understand factors affecting both lose and recovery patterns of BMD for HIV infected women on lifetime ART. AIM 1: We will gather baseline BMD data at entry into PROMOTE and compare to prior DXA measures in PROMISE in order to assess changes clinical risk factors for low BMD in HIV Infected women AIM 2: for HIV infected women who have a repeat pregnancy during PROMOTE follow up, determine BMD loss and recovery patterns: and bone biomarker changes during 36 months follow up post delivery and compare results to age group, parity and site matched HIV negative pregnant women; AIM 3: compare BMD and bone biomarker findings with PROMOTE mothers matched for age group, parity and site but who do not conceive during 36 months of follow up. This research will elucidate whether decreases in BMD among HIV infected mothers on lifetime ART are exacerbated with repeat pregnancy/breastfeeding and if BMD recovery at the end of breastfeeding is decrease when compared to HIV negative women at the end of breastfeeding.

DXA R01 项目概要 PROMISE 1077BF 试验发现，18 个月后骨矿物质密度 (BMD) 显着降低 无症状艾滋病毒感染母亲的分娩，随机接受抗逆转录病毒治疗（ART） 与婴儿随机接受奈韦拉平治疗的母亲相比，延长母乳喂养时间 母乳喂养期间的预防。母乳喂养也与 BMD 短暂下降有关，但通常 其次是BMD恢复。在艾滋病毒感染女性中，终生 ART 重复治疗的长期影响 怀孕/重复母乳喂养对艾滋病毒感染母亲的母亲骨密度的影响仍然未知。然而我们的 PROMISE 的初步研究结果显示，母乳喂养期间接受 ART 治疗后 BMD 会降低，这引起了人们对母乳喂养期间 BMD 降低的担忧。 与未感染艾滋病毒的母亲相比，早期骨质减少或骨质疏松症的风险可能增加 并且终生未接触过 ART。 鉴于这些有希望的发现，我们建议对重复怀孕时 BMD 的变化进行纵向随访 并在 PROMISE 试验中感染艾滋病毒的母亲中延长母乳喂养，这些母亲现已加入该试验 促进马拉维布兰太尔和乌干达坎帕拉站点的队列随访研究，以便更好地 了解影响终生接受 ART 的 HIV 感染女性 BMD 损失和恢复模式的因素。 目标 1：我们将在进入 PROMOTE 时收集基线 BMD 数据，并与之前的 DXA 测量值进行比较 PROMISE 旨在评估 HIV 感染女性低 BMD 临床危险因素的变化 目标 2：对于在 PROMOTE 随访期间再次怀孕的 HIV 感染女性，确定 BMD 损失和恢复模式：以及产后 36 个月随访期间骨生物标志物的变化 将结果与年龄组、产次和地点匹配的 HIV 阴性孕妇进行比较； 目标 3：将 BMD 和骨生物标志物结果与按年龄组、产次和年龄相匹配的 PROMOTE 母亲进行比较 但在 36 个月的随访期间没有怀孕。 这项研究将阐明终生接受抗逆转录病毒治疗的艾滋病毒感染母亲的骨密度下降是否与 重复怀孕/母乳喂养以及母乳喂养结束时 BMD 恢复下降会加剧 与母乳喂养结束时艾滋病毒呈阴性的女性相比。