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
基本信息
- 批准号:10805834
- 负责人:
- 金额:$ 22.36万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-06-01 至 2024-05-31
- 项目状态:已结题
- 来源:
- 关键词:Administrative SupplementAffectBiological MarkersBirthBone DensityBreast FeedingCOVID-19 pandemicCalciumCohort StudiesDataDual-Energy X-Ray AbsorptiometryEnrollmentFollow-Up StudiesGoalsGrantHIVHIV SeronegativityInfantLactationLifeMalawiMaternal HealthMeasuresMetabolicMilkMineralsMothersNevirapineOsteopeniaOsteoporosisOutcomeParticipantPatternPregnancyPregnant WomenProphylactic treatmentRandomizedRecoveryReportingRiskRisk FactorsScanningSiteTenofovirTimeUgandaWomanadverse outcomeage groupantiretroviral therapybonebone healthbone lossclinical research siteclinical riskcohortfollow-upparityprospective
项目摘要
PROJECT SUMMARY / ABSTRACT
Among HIV-infected women, the longer-term impact that lifetime antiretroviral therapy (ART) with
repeat pregnancy followed by breastfeeding has on maternal health outcomes including bone mineral
density (BMD), in particular, remains unknown. Findings from the PROMISE 1077BF trial indicated that
BMD significantly decreased among asymptomatic HIV-infected mothers randomized to receive ART
during extended breastfeeding compared to mothers whose infants were randomized to receive
nevirapine prophylaxis during breastfeeding. Breastfeeding was also associated with transient decreases
in BMD but was usually followed by BMD recovery. Lactating women with HIV taking tenofovir-based
ART had altered milk mineral composition (i.e. calcium) when compared to women without HIV.
These initial results from the PROMISE trial reporting BMD decreases with ART during breastfeeding and
metabolic differences for lactating mothers on ART from the Gumba study raise concerns about
potentially increased risk of early osteopenia or osteoporosis compared to mothers are not HIV-infected
and not exposed to lifetime ART. To better understand this relationship, the Maternal Bone Health
Study (MBHS) is a prospective longitudinal follow up study being conducted to assess BMD changes with
repeat pregnancy and extended breastfeeding among HIV-infected mothers from the PROMISE trial who
are now enrolled as participants in the PROMOTE cohort. This observational MBHS is being conducted at
clinical research sites in Blantyre, Malawi and Kampala, Uganda to explore factors which may affect
bone health and both loss and recovery patterns of BMD for HIV-infected women on lifetime ART.
The Specific Aims of the MBHS are: (1) to gather baseline BMD data at entry into PROMOTE and to
compare to prior bone density scans, DXA measures, from PROMISE in order to assess changes clinical
risk factors for low BMD in HIV-infected women and (2) to determine BMD loss and recovery patterns in
from bone biomarker changes during a 36-month post-delivery period among HIV-infected women who
have a repeat pregnancy during PROMOTE follow up with results being compared to age group- and
parity-matched HIV-negative pregnant women at each site. Lastly, the MBHS will aim (3) to compare
BMD and bone biomarker findings with PROMOTE mothers matched for age group and parity by site
who do not conceive during 36 months of follow-up. These comparisons will elucidate whether
decreases in BMD among HIV-infected mothers on lifetime ART are exacerbated with repeat
pregnancy/breastfeeding and if BMD recovery after breastfeeding is further decreased when compared
to HIV-negative women at the end of breastfeeding. The long-term goal of this cohort study is to better
support the bone health of breastfeeding women living with HIV who are on lifetime ART. The
requested administrative supplement will allow completion of the crucial 36 month outcomes.
项目概要/摘要
对于感染艾滋病毒的女性来说,终身抗逆转录病毒治疗(ART)的长期影响
再次怀孕后进行母乳喂养会影响孕产妇健康结果,包括骨矿物质
尤其是密度(BMD)仍然未知。 PROMISE 1077BF 试验的结果表明
随机接受 ART 的无症状 HIV 感染母亲的 BMD 显着下降
与婴儿随机接受母乳喂养的母亲相比,在延长母乳喂养期间
母乳喂养期间奈韦拉平预防。母乳喂养也与短暂的减少有关
骨密度,但通常随后是骨密度恢复。服用替诺福韦为基础药物的艾滋病毒哺乳期妇女
与未感染艾滋病毒的女性相比,ART 改变了乳汁矿物质成分(即钙)。
PROMISE 试验的这些初步结果报告了母乳喂养期间 BMD 随 ART 的增加而降低,
Gumba 研究显示,接受 ART 治疗的哺乳期母亲的代谢差异引起了人们的担忧
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。为了更好地了解这种关系,孕产妇骨骼健康
研究 (MBHS) 是一项前瞻性纵向随访研究,旨在评估 BMD 变化
PROMISE 试验中感染艾滋病毒的母亲重复怀孕并延长母乳喂养
现已注册为 PROMOTE 队列的参与者。该观察性 MBHS 正在进行
马拉维布兰太尔和乌干达坎帕拉的临床研究中心探索可能影响的因素
终生接受 ART 的 HIV 感染妇女的骨骼健康以及 BMD 损失和恢复模式。
MBHS 的具体目标是:(1) 在进入 PROMOTE 时收集基线 BMD 数据并
与 PROMISE 之前的骨密度扫描、DXA 测量进行比较,以评估临床变化
HIV 感染女性 BMD 低的危险因素,以及 (2) 确定 BMD 损失和恢复模式
感染 HIV 的女性在产后 36 个月期间骨生物标志物的变化
在 PROMOTE 随访期间再次怀孕,并将结果与年龄组和
每个地点的同次匹配的艾滋病毒阴性孕妇。最后,MBHS 的目标是 (3) 比较
PROMOTE 母亲的 BMD 和骨生物标志物结果与年龄组和按部位的产次相匹配
在 36 个月的随访期间没有怀孕的人。这些比较将阐明是否
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随着重复治疗而加剧
怀孕/哺乳期以及母乳喂养后 BMD 恢复是否进一步下降
母乳喂养结束时艾滋病毒呈阴性的妇女。本队列研究的长期目标是更好地
支持终生接受抗逆转录病毒治疗的艾滋病毒感染者母乳喂养妇女的骨骼健康。这
请求的行政补充将有助于完成关键的 36 个月结果。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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MARY Glenn Fowler其他文献
MARY Glenn Fowler的其他文献
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{{ truncateString('MARY Glenn Fowler', 18)}}的其他基金
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 - 财政年份:2018
- 资助金额:
$ 22.36万 - 项目类别:
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:
10456636 - 财政年份:2018
- 资助金额:
$ 22.36万 - 项目类别:
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
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