Evidence map›Paper›PMID 26060285›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Lower Newborn Bone Mineral Content Associated With Maternal Use of Tenofovir Disoproxil Fumarate During Pregnancy.

George K Siberry, Denise L Jacobson, Heidi J Kalkwarf, Julia W Wu, Linda A DiMeglio, Ram Yogev, Katherine M Knapp, Justin J Wheeler, Laurie Butler, Rohan Hazra and 8 more

2 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 60 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 4 pooled it
17.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01310023 completednot on this map

Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

TypeobservationalSponsorHarvard School of Public Health (HSPH)Ran2007 to 2025Enrolled5,169ConditionsAntiretroviral Toxicity
NCT02995005 phase1 / phase2completednot on this mapstarted 2018, after this paper: background citation

Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2018 to 2023Enrolled98ConditionsHepatitis BArmsTenofovir Disoproxil Fumarate
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 4 syntheses or guidelines pooled it, 118 citations in OpenAlex.

  1. Pooled it
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  5. Trial
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  12. Bone health across the lifespan in African populations affected by HIV.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026
    Article
  13. Longitudinal comparison of bone, growth, and biochemical markers in breastfed HIV-exposed uninfected and HIV-unexposed Ugandan children.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026
    Article
  14. Observational
  15. Frontiers in endocrinology · 2026
    Article
  16. Review
  17. Article
  18. Frontiers in pediatrics · 2024
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 15 institutions in 1 country.

George K SiberryMaternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Denise L JacobsonCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Heidi J KalkwarfDivision of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, Ohio.
Julia W WuDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Linda A DiMeglioSection of Pediatric Endocrinology/Diabetology, Department of Pediatrics, Riley Hospital for Children at Indiana University Health, Indiana University School of Medicine, Indianapolis.
Ram YogevLurie Children's Hospital, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Katherine M KnappDepartment of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee.
Justin J WheelerTufts University Body Composition Analysis Center, Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, Boston, Massachusetts.
Laurie ButlerFrontier Science Technology and Research Foundation, Amherst, New York.
Rohan HazraMaternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Tracie L MillerDepartment of Pediatrics, Miller School of Medicine at the University of Miami, Florida.
George R SeageDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Russell B Van DykeDepartment of Pediatrics, Tulane University School of Medicine, New Orleans, Louisiana.
Emily BarrChildren's Hospital Colorado, Department of Infectious Disease, University of Colorado, Denver.
Mariam DavtyanLAC+USC Maternal, Child & Adolescent Center for Infectious Diseases and Virology, Los Angeles, California.
Lynne M MofensonMaternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Kenneth C RichDepartment of Pediatrics, University of Illinois at Chicago.
Pediatric HIV/AIDS Cohort Study
Harvard University · USNational Institutes of Health · USCancer Research And Biostatistics · USChildren's Hospital Colorado · USCincinnati Children's Hospital Medical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USFrontier Science & Technology Research Foundation · USIndiana University – Purdue University Indianapolis · USLAC+USC Medical Center · USLurie Children's Hospital · USSt. Jude Children's Research Hospital · USTufts University · USTulane University · USUniversity of Illinois Chicago · USUniversity of Miami · US

Funding

PHACS - Data and Operations CenterU01HD052102 · NICHD · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI WILLIAMS, PAIGE L · 2005 to 2019
$242.7M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
Indiana Clinical and Translational Sciences InstituteUL1TR001108 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI DENNE, SCOTT C., SHEKHAR, ANANTHA · 2013 to 2017
$23.3M
Pediatric HIV/AIDS Cohort Study (PHACS): Understanding Maternal HIV Disease through Pregnancy and the Postpartum Period and its Role in Child Health OutcomesU01HD052104 · NICHD · TULANE UNIVERSITY OF LOUISIANA · PI VAN DYKE, RUSSELL B. · 2005 to 2019
$15.7M
NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001108NICHD NIH HHS U01 HD052102NICHD NIH HHS U01 HD052104
6 · The paper itself

Abstract

backgroundFetal bone effects of maternal tenofovir use have not been well studied. We sought to compare whole-body bone mineral content (BMC) of newborns exposed vs not exposed to tenofovir in utero.

methodsWe enrolled participants from April 2011 to June 2013 at 14 US clinical sites. Singleton infants of women with human immunodeficiency virus (HIV) infection who took tenofovir in late pregnancy (tenofovir-exposed) or no tenofovir during pregnancy (tenofovir-unexposed) were enrolled during late pregnancy or within 72 hours of birth. Infants born before 36 weeks gestation or with confirmed HIV infection were excluded. Whole-body BMC was measured in the first month of life and compared with that of the tenofovir-exposed and tenofovir-unexposed newborns, unadjusted and adjusted for covariates.

resultsSeventy-four tenofovir-exposed and 69 tenofovir-unexposed infants had evaluable BMC measurements. Tenofovir-exposed mothers were more likely to be married (31% vs 22%; P = .04) and to use boosted protease inhibitors (84% vs 62%; P = .004). Tenofovir-exposed newborns did not differ from unexposed newborns on mean gestational age (38.2 vs 38.1 weeks) or mean length (-0.41 vs -0.18) or weight (-0.71 vs -0.48) Z-scores. The mean (standard deviation) BMC of tenofovir-exposed infants was 12% lower than for unexposed infants (56.0 [11.8] vs 63.8 [16.6] g; P = .002). The adjusted mean bone mineral content was 5.3 g lower (95% confidence interval, -9.5, -1.2; P = .013) in the tenofovir-exposed infants.

conclusionsMaternal tenofovir use is associated with significantly lower neonatal BMC. The duration and clinical significance of this finding should be evaluated in longitudinal studies. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT01310023.

Indexed as

Bone DensityMaternal ExposureAdultAnti-HIV AgentsCross-Sectional StudiesFemaleHIV InfectionsHumansInfant, NewbornPregnancyPregnancy Complications, InfectiousTenofovirUnited StatesAnti-HIV AgentsTenofovirHIVinfant bone mineral contentintrauterine exposuretenofovir

Identifiers

PMID26060285
PMCPMC4551007
OpenAlexW2178752996

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.