Evidence map›Paper›PMID 30280906›Full record

Observational studyAIDS research and human retroviruses2019

Short Communication: Association of Vitamin D Insufficiency and Protective Tenofovir Diphosphate Concentrations with Bone Toxicity in Adolescent Boys and Young Men Using Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Pre-Exposure Prophylaxis.

Peter L Havens, Ashutosh Tamhane, Charles B Stephensen, Gertrud U Schuster, Catherine M Gordon, Nancy Liu, Craig M Wilson, Sybil G Hosek, Peter L Anderson, Bill G Kapogiannis and 1 more

Registry-linked trialOpen access · greenAbstract readObservational Study
In one paragraph

Observational study in AIDS research and human retroviruses, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01769469 (Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 16% 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.

NCT01769469 completednot on this map

Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men.

TypeobservationalSponsorUniversity of North Carolina, Chapel HillRan2012 to 2015Enrolled101ConditionsHIV InfectionArmsFTC/TDF (Truvada®)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Observational
  5. Article
  6. Preexposure Prophylaxis for Prevention of HIV Acquisition Among Adolescents: Clinical Considerations, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
    Article
  7. 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

11 authors at 10 institutions in 1 country.

Peter L Havens1 Department of Pediatrics, Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
Ashutosh Tamhane2 Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama.
Charles B Stephensen3 United States Department of Agriculture, Agricultural Research Service, Western Human Nutrition Research Center, Davis, California.
Gertrud U Schuster4 Department of Nutrition, University of California, Davis, California.
Catherine M Gordon5 Department of Pediatrics, University of Cincinnati College of Medicine/Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Nancy Liu6 Westat, Rockville, Maryland.
Craig M Wilson7 Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama.
Sybil G Hosek8 Department of Psychiatry, Stroger Hospital of Cook County, Chicago, Illinois.
Peter L Anderson9 Department of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
Bill G Kapogiannis10 Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Kathleen Mulligan11 Department of Medicine, University of California at San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California.
University of Alabama at Birmingham · USChildren's Hospital of Wisconsin · USCincinnati Children's Hospital Medical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USJohn H. Stroger, Jr. Hospital of Cook County · USSan Francisco General Hospital · USUnited States Department of Agriculture · USUniversity of California, Davis · USUniversity of Colorado Anschutz Medical Campus · USWestat (United States) · US

Funding

Adol. Medicine Trials Network for HIV/AIDS InterventionsU01HD040474 · NICHD · WESTAT, INC. · PI HARRIS, DONALD ROBERT · 2001 to 2016
$114.4M
LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
NICHD NIH HHS U01 HD040474NICHD NIH HHS U01 HD040533
6 · The paper itself

Abstract

We examined associations of 25-hydroxy vitamin D (25-OHD), tenofovir disoproxil fumarate (TDF), and bone toxicity. We studied TDF/emtricitabine (FTC) HIV pre-exposure prophylaxis (PrEP) in young men who have sex with men (YMSM). Bone toxicity was predefined using bone mineral density/content change from baseline to week 48. Baseline serum 25-OHD was dichotomized as <20 ng/mL (insufficient/deficient) versus ≥20 (sufficient), and week 48 dried blood spot tenofovir diphosphate (TFV-DP) as >700 fmol/punch (protective against HIV acquisition) versus ≤700. Associations were examined by univariate and multivariable logistic regression, reporting crude and adjusted odds ratios (ORs), with 95% confidence intervals (CIs). Of 101 enrolled, 69 had complete bone assessments and 25-OHD; of these, 59 had week 48 TFV-DP data. Median (Q1-Q3) age was 20 (18-21) years; 54% were black/African American. In univariate analysis, participants with baseline 25-OHD <20 ng/mL (OR = 5.4; 95% CI = 1.9-16.5) and blacks (OR = 4.9; 95% CI = 1.7-15.2) had greater odds of bone toxicity than those with 25-OHD ≥20 or other races. TFV-DP was not associated with bone toxicity (OR = 1.6; 95% CI = 0.5-5.5). In multivariable analysis, compared with those with 25-OHD ≥20 and TFV-DP ≤700, those with 25-OHD ≥20 and TFV-DP >700 (OR = 11.5; 95% CI = 1.4-169.6), 25-OHD <20 and TFV-DP ≤700 (OR = 19.4; 95% CI = 3.0-228.7), and 25-OHD <20 and TFV-DP >700 (OR = 32.3; 95% CI = 3.3-653.6) had greater odds of bone toxicity after adjusting for race. In multivariable models, 25-OHD insufficiency, protective TFV-DP concentrations, and black race were significantly associated with bone toxicity after 48 weeks of TDF/FTC PrEP in YMSM. Clinical Trials Registration: NCT01769469.

Indexed as

Pre-Exposure ProphylaxisVitamin D DeficiencyAdolescentAnti-HIV AgentsBone and BonesEmtricitabineHIV InfectionsHomosexuality, MaleHumansLogistic ModelsMaleProspective StudiesTenofovirVitamin DYoung Adult25-hydroxyvitamin DAnti-HIV AgentsEmtricitabineTenofovirVitamin D25-hydroxy vitamin Dbone mineral densityHIV pre-exposure prophylaxistenofovir disoproxil fumarate

Identifiers

PMID30280906
PMCPMC6360393
OpenAlexW2895586456

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.