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 R 01项目总结 PROMISE 1077 BF试验发现，18个月后骨密度（BMD）显著降低 随机接受抗逆转录病毒治疗（ART）的无症状HIV感染母亲的分娩情况 与婴儿随机接受奈韦拉平的母亲相比， 母乳喂养期间的预防。母乳喂养也与骨密度的短暂下降有关，但通常 然后BMD恢复。在感染艾滋病毒的妇女中，终生抗逆转录病毒治疗的长期影响 妊娠/重复母乳喂养对HIV感染母亲的BMD的影响尚不清楚。然而我们的 PROMISE关于母乳喂养期间ART导致BMD降低的初步研究结果引起了人们对 与未感染HIV的母亲相比，早期骨质减少或骨质疏松症的潜在风险增加 而不是终生接触艺术。 鉴于这些PROMISE结果，我们建议对重复妊娠的BMD变化进行纵向随访 在PROMISE试验中感染HIV的母亲中， 促进在布兰太尔马拉维和坎帕拉乌干达研究中心的队列随访研究，以便更好地 了解影响终生接受抗逆转录病毒治疗的HIV感染妇女骨密度丢失和恢复模式的因素。 目的1：我们将在进入PROMOTE时收集基线BMD数据，并与之前的DXA测量结果进行比较， PROMISE，以评估HIV感染妇女中低BMD的临床风险因素的变化 目的2：对于在PROMOTE随访期间再次妊娠的HIV感染妇女，测定BMD 丢失和恢复模式：以及分娩后36个月随访期间的骨生物标志物变化， 将结果与年龄组、产次和地点匹配的艾滋病毒阴性孕妇进行比较; 目的3：比较年龄组、产次和性别匹配的PROMOTE母亲的BMD和骨生物标志物结果， 但在36个月的随访期间没有怀孕。 这项研究将阐明，是否减少骨密度艾滋病毒感染的母亲终身抗逆转录病毒治疗， 重复妊娠/母乳喂养加重，如果母乳喂养结束时BMD恢复下降 与母乳喂养结束时的艾滋病毒阴性妇女相比。