Trial reportJournal of acquired immune deficiency syndromes (1999)2017
Brief Report: Recovery of Bone Mineral Density After Discontinuation of Tenofovir-Based HIV Pre-exposure Prophylaxis.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00458393 (Chemoprophylaxis for HIV Prevention in Men), which is not on this map. Cited by 19 papers.
What it found
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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.
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.
Chemoprophylaxis for HIV Prevention in Men
Who cites it
19 citing papers in PubMed.
- Trial
- Bone Changes With Long-Acting Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention in Cisgender Men and Transgender Women: HPTN 083.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Bone changes with candidate PrEP regimens containing tenofovir disoproxil fumarate and/or maraviroc and/or emtricitabine in US men and women: HPTN 069/ACTG A5305.The Journal of antimicrobial chemotherapy · 2022Trial
- Changes in Bone Mass After Discontinuation of Preexposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine in Young Men Who Have Sex With Men: Extension Phase Results of Adolescent Trials Network Protocols 110 and 113.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Trial
- Bilateral Pathological Femoral Fractures Secondary to Long-Term Tenofovir Disoproxil Fumarate-Induced Osteomalacia in a Woman Living with HIV: A Case Report.International medical case reports journal · 2026Article
- HIV pre-exposure prophylaxis: It is time to consider harm reduction care for adolescents in Canada.Paediatrics & child health · 2023Article
- Prevalence of renal and bone risk factors among individuals prescribed oral pre-exposure prophylaxis for HIV.IJID regions · 2023Article
- Safety review of tenofovir disoproxil fumarate/emtricitabine pre-exposure prophylaxis for pregnant women at risk of HIV infection.Expert opinion on drug safety · 2021Review
- People living with HIV and fracture risk.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020Review
- Article
- Preexposure Prophylaxis for Prevention of HIV Acquisition Among Adolescents: Clinical Considerations, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020Article
- Article
- Bone Update: Is It Still an Issue Without Tenofovir Disoproxil Fumarate?Current HIV/AIDS reports · 2020Review
- Impact of Estimated Pre-Exposure Prophylaxis (PrEP) Adherence Patterns on Bone Mineral Density in a Large PrEP Demonstration Project.AIDS research and human retroviruses · 2019Article
- Current and Future PrEP Medications and Modalities: On-demand, Injectables, and Topicals.Current HIV/AIDS reports · 2019Review
- Primary Care Physician Attitudes and Intentions Toward the Use of HIV Pre-exposure Prophylaxis in Adolescents in One Metropolitan Region.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2019Article
- Pre-exposure Prophylaxis for HIV Infection in the Older Patient: What can be Recommended?Drugs & aging · 2018Review
- Oral Pre-Exposure Prophylaxis (PrEP) for HIV Prevention in Adolescents and Young Adults.Current pediatrics reports · 2018Article
- Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
backgroundOral tenofovir disoproxil fumarate (TDF) for HIV prevention and treatment is associated with decreases in bone mineral density (BMD). Previous reports suggest that these changes may be reversible after discontinuation of TDF.
settingA metabolic substudy of 498 participants in a randomized, placebo-controlled HIV prevention trial of oral coformulated TDF with emtricitabine (TDF/FTC, Truvada) for HIV pre-exposure prophylaxis (PrEP) enrolling a global sample of men who have sex with men and trans women.
methodsParticipants underwent dual X-ray absorptiometry to quantify bone mineral density (BMD) in the hip and spine during PrEP and at 2 visits after stopping (median of 23 and 79 weeks post-PrEP, respectively). Results are stratified by pharmacologic measure of TDF/FTC adherence.
resultsThere was no significant difference in change in hip/spine BMD at any time point between placebo and those with low adherence. Adherent participants had a mean (standard error) BMD change at TDF/FTC discontinuation of -1.02% (0.24) in the hip and -1.84% (0.36) in the spine. After stop, annualized BMD increases of 1.13% per year (0.27) in hip and 1.81% per year (0.36) in spine BMD were observed in adherent participants compared with 0.19% (0.16) and 0.74% (0.21) in the placebo group, respectively (P = 0.003, both comparisons). On average, BMD returned to baseline levels by 1 year after PrEP stop. Recovery was consistent across age, baseline BMD z-score, and treatment duration.
conclusionsMean BMD returns to baseline levels within 12-18 months after TDF-based PrEP discontinuation in both hip and spine with consistency across participant subgroups. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov NCT00458393.
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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.