Evidence map›Paper›PMID 31660332›Full record

ArticleOpen forum infectious diseases2019

Impact of Tenofovir-Based Pre-exposure Prophylaxis on Biomarkers of Bone Formation, Bone Resorption, and Bone Mineral Metabolism in HIV-Negative Adults.

Thomas L Nickolas, Michael T Yin, Ting Hong, Kenneth K Mugwanya, Andrea D Branch, Renee Heffron, Janaina Ramalho, Renu Nandakumar, Elzbieta Dworakowski, Valentine Wanga and 7 more

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 5 institutions in 3 countries.

Thomas L NickolasDepartment of Medicine, Columbia University Medical Center, New York, New York.
Michael T YinDepartment of Medicine, Columbia University Medical Center, New York, New York.
Ting HongDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.
Kenneth K MugwanyaDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.
Andrea D BranchDepartment of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
Renee HeffronDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.
Janaina RamalhoDepartment of Medicine, Columbia University Medical Center, New York, New York.
Renu NandakumarDepartment of Medicine, Columbia University Medical Center, New York, New York.
Elzbieta DworakowskiDepartment of Medicine, Columbia University Medical Center, New York, New York.
Valentine WangaDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.
Nelly R MugoDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.
Allan RonaldDepartments of Medicine and Medical Microbiology, University of Manitoba, Manitoba, Canada.
Connie CelumDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.
Deborah DonnellDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.
Jared M BaetenDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.
Christina M WyattDepartment of Medical Center, Duke University School of Medicine and Duke Clinical Research Institute, Durham, North Carolina.
Partners PrEP Study Team
University of Washington · USColumbia University Irving Medical Center · USUniversity of Manitoba · CAClinical Research Institute · USIcahn School of Medicine at Mount Sinai · US

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
PILOT STUDY--CLINICAL NUTRITION RESEARCHP30DK035816 · NIDDK · UNIVERSITY OF WASHINGTON · PI Ellen A Schur · 1986 to 2026
$30.4M
Impact of Concurrent Initiation of DMPA Contraception and Tenofovir PrEP on Bone Loss in Young WomenR01HD089843 · NICHD · UNIVERSITY OF WASHINGTON · PI HEFFRON, RENEE A. · 2017 to 2021
$3.9M
Impact of early antiretroviral therapy on kidney disease outcomesR01DK112258 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI WYATT, CHRISTINA M · 2017 to 2021
$2.1M
Incidence and Implications of Subclinical Kidney Injury with Tenofovir based PrEPR01DK100272 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI WYATT, CHRISTINA M · 2014 to 2016
$1.8M
A differentiated care model to improve the efficiency of PrEP delivery in KenyaR00MH118134 · NIMH · UNIVERSITY OF WASHINGTON · PI MUGWANYA, KENNETH KIGGUNDU · 2019 to 2021
$743k
A differentiated care model to improve the efficiency of PrEP delivery in KenyaK99MH118134 · NIMH · UNIVERSITY OF WASHINGTON · PI MUGWANYA, KENNETH KIGGUNDU · 2018 to 2018
$123k
NIAID NIH HHS P30 AI027757NICHD NIH HHS R01 HD089843NIDDK NIH HHS P30 DK035816NIDDK NIH HHS R01 DK100272NIDDK NIH HHS R01 DK112258NIMH NIH HHS K99 MH118134NIMH NIH HHS R00 MH118134
6 · The paper itself

Abstract

backgroundPre-exposure prophylaxis (PrEP) with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) reduces the risk of HIV seroconversion but may promote bone mineral density (BMD) decline. The mechanisms of BMD decline with FTC/TDF remain unclear, and studies in HIV-positive individuals have been confounded by the effects of HIV and concomitant antiretroviral medications. We evaluated the impact of FTC/TDF on biomarkers of bone remodeling and bone mineral metabolism in HIV-negative men and women enrolled in the Partners PrEP Study.

methodsIn a random sample of HIV-negative participants randomized to FTC/TDF PrEP (n = 50) or placebo (n = 50), serum parathyroid hormone (PTH), bone biomarkers (C-telopeptide, procollagen 1 intact N-terminal propeptide, and sclerostin), and plasma fibroblast growth factor 23 were measured at baseline and month 24, and the percentage change was compared between groups. In a complementary analysis, we compared the change in biomarkers between participants with and without a 25% decline in glomerular filtration rate (GFR) on FTC/TDF.

resultsBaseline characteristics were similar between the groups (median age, 38 years; 40% women). Vitamin D insufficiency was common, but baseline GFR and PTH were in the normal range. We observed a significantly greater percent increase in serum C-telopeptide in participants randomized to FTC/TDF vs placebo (

conclusionsIncreased bone remodeling may mediate the BMD decline observed with tenofovir-containing PrEP and antiretroviral therapy, independent of a TDF-mediated decrease in kidney function.

Indexed as

antiretroviral therapybone turnoverHIV preventionkidneytubular dysfunction

Identifiers

PMID31660332
PMCPMC6778426
OpenAlexW2966680488

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.