Trial reportJournal of acquired immune deficiency syndromes (1999)2016
Bone Mineral Density Changes Among Young, Healthy African Women Receiving Oral Tenofovir for HIV Preexposure Prophylaxis.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Canadian guideline on HIV pre-exposure prophylaxis and nonoccupational postexposure prophylaxis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2017Guideline
- Effectiveness and safety of oral HIV preexposure prophylaxis for all populations.AIDS (London, England) · 2016Pooled it
- Trial
- Safety, tolerability, and acceptability of long-acting injectable cabotegravir for HIV prevention in cisgender female adolescents (HPTN 084-01): a single-arm, open-label, phase 2b trial.The lancet. HIV · 2025Trial
- In-utero exposure to tenofovir-containing pre-exposure prophylaxis and bone mineral content in HIV-unexposed infants in South Africa.Journal of the International AIDS Society · 2024Trial
- 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
- Trial
- 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
- Brief Report: Recovery of Bone Mineral Density After Discontinuation of Tenofovir-Based HIV Pre-exposure Prophylaxis.Journal of acquired immune deficiency syndromes (1999) · 2017Trial
- Changes in Bone Mineral Density, Body Composition, Vitamin D Status, and Mineral Metabolism in Urban HIV-Positive South African Women Over 12 Months.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2017Trial
- Article
- The effect of daily oral PrEP use during pregnancy on bone mineral density among adolescent girls and young women in Uganda.Frontiers in reproductive health · 2023Article
- Impact of Tenofovir Disoproxil Fumarate Use During Pregnancy on Maternal Bone Mineral Density.The Pediatric infectious disease journal · 2022Article
- Safety review of tenofovir disoproxil fumarate/emtricitabine pre-exposure prophylaxis for pregnant women at risk of HIV infection.Expert opinion on drug safety · 2021Review
- Recent Advances and New Challenges in Cisgender Women's Gynecologic and Obstetric Health in the Context of HIV.Clinical obstetrics and gynecology · 2021Review
- Patient-Focused Selection of PrEP Medication for Individuals at Risk of HIV: A Narrative Review.Infectious diseases and therapy · 2021Review
- Low bone mass in people living with HIV on long-term anti-retroviral therapy: A single center study in Uganda.PloS one · 2021Article
- 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
- Bone Update: Is It Still an Issue Without Tenofovir Disoproxil Fumarate?Current HIV/AIDS reports · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 6 institutions in 3 countries.
Funding
Abstract
backgroundLimited data exist on effect of tenofovir disoproxil fumarate (TDF) when used for preexposure prophylaxis (PrEP) on bone mineral density (BMD) in HIV-negative women. We evaluated the effect of daily oral TDF and emtricitabine/TDF compared with placebo on BMD among women enrolled in an HIV-1 PrEP trial.
methodsHIV-uninfected women in Uganda and Zimbabwe had BMD measurements of lumbar spine (LS) and total hip (TH) by dual-energy x-ray absorptiometry at baseline and every 24 weeks for 48 weeks of active treatment and for 48 weeks after discontinuation of study medication. Plasma tenofovir levels were assessed every 12 weeks for the first 48 weeks.
resultsOf 518 women enrolled, 432 had dual-energy x-ray absorptiometry results at baseline and week 48. In the primary analysis, no significant differences in percent BMD change in hip or spine between arms observed, likely because of low product adherence. Among the subset with tenofovir detection in 75%-100% of plasma samples, the mean percent BMD change from baseline to week 48 in the LS was 1.4% lower for TDF or emtricitabine/TDF recipients than for placebo (P = 0.002) and TH BMD was 0.9% lower (P = 0.018). BMD changes from end of active treatment to 48 weeks were significantly greater in the active arm participants compared with placebo participants with a net difference of approximately +0.9% at the LS (P = 0.007) and +0.7% (P = 0.003) at the TH.
conclusionsTDF-containing oral PrEP resulted in small but significant reversible decreases in hip and spine BMD among young African women.
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What OpenQuestion holds
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.