Evidence map›Paper›PMID 29623648›Full record

Observational studyDrug safety2018

Osteoporosis-Related Fractures in HIV-Infected Patients Receiving Long-Term Tenofovir Disoproxil Fumarate: An Observational Cohort Study.

Ayami Komatsu, Atsushi Ikeda, Akio Kikuchi, Chiaki Minami, Motomu Tan, Shuzo Matsushita

Abstract readObservational Study
In one paragraph

Observational study in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

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

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Clinical insights into the association between chronic liver disease and osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Review
  4. Article
  5. Article
  6. Article
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  8. Review
  9. Article
  10. Article
  11. Article
  12. Comparison of bone mineral density changes between denosumab and bisphosphonates in tenofovir-exposed chronic hepatitis B patients with osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Article
  13. Article
  14. Review
  15. Article
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  19. Review
  20. Longitudinal change in bone mineral density among Chinese individuals with HIV after initiation of antiretroviral therapy.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    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

6 authors.

Ayami KomatsuPharmaceutical Division, Drug Safety and Risk Management Department, Japan Tobacco Inc., Tokyo, Japan. ayami.komatsu@jt.com.ORCID 0000-0002-1673-3490
Atsushi IkedaPharmaceutical Division, Drug Safety and Risk Management Department, Japan Tobacco Inc., Tokyo, Japan.
Akio KikuchiPharmaceutical Division, Drug Safety and Risk Management Department, Japan Tobacco Inc., Tokyo, Japan.
Chiaki MinamiPharmaceutical Division, Drug Safety and Risk Management Department, Japan Tobacco Inc., Tokyo, Japan.
Motomu TanPharmaceutical Division, Drug Safety and Risk Management Department, Japan Tobacco Inc., Tokyo, Japan.
Shuzo MatsushitaCenter for AIDS Research, Kumamoto University, Kumamoto, Japan. shuzo@kumamoto-u.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with HIV infection may have a higher prevalence of osteoporosis and osteopenia, as well as an increased risk of bone fracture compared with non-HIV-infected individuals. Antiretroviral therapy is thought to be one of factors associated to osteoporosis-related bone fractures.

objectiveThe aim of this study was to assess the effects of long-term exposure to tenofovir disoproxil fumarate (TDF) on the cumulative risk of osteoporosis-related bone fractures in Japanese patients with HIV infection.

designThis observational cohort study comprised a joint HIV-related drug survey of patients treated with TDF between April 2004 and March 2013.

methodsThirty-five healthcare facilities in Japan participated in the survey. The incidence of osteoporosis-related fractures was extracted from all adverse events (AEs) using standardized Medical Dictionary for Regulatory Activities queries, and used to calculate the fracture rate per 10,000 patient-years (PY). Kaplan-Meier analysis was used to estimate the cumulative probability of fracture during the study period.

resultsA total of 3251 patients who received TDF or TDF/emtricitabine between April 2004 and March 2013 were analyzed in this study; 93.5% of patients were male. The fracture rate was 13.5 per 10,000 PY in males and 42.2 per 10,000 PY in females. The mean age for male patients with osteoporosis-related fracture was 43.2 years, whereas it was 65.7 years in female patients. The cumulative probability of osteoporosis-related fracture increased after ≥ 5 years of TDF exposure. The rate of hip fracture (95% confidence interval) was 7.2 (3.1-14.2) per 10,000 PY.

conclusionsAmong HIV-infected patients in Japan, treatment with TDF for ≥ 5 years increases the risk of bone fractures in younger men, in addition to that seen in older post-menopausal women.

Indexed as

AdultAgedAnti-HIV AgentsCohort StudiesDrug Administration ScheduleFemaleFractures, BoneHIV InfectionsHumansJapanLongitudinal StudiesMaleMiddle AgedOsteoporosisTenofovirAnti-HIV AgentsTenofovir

Identifiers

PMID29623648
PMCPMC6061259

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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.