A higher dosage of oral alendronate will increase the subsequent cancer risk of osteoporosis patients in Taiwan: a population-based cohort study

PLoS One. 2012;7(12):e53032. doi: 10.1371/journal.pone.0053032. Epub 2012 Dec 31.

Abstract

Background: Controversy still exists regarding whether alendronate (ALN) use increases the risk of esophageal cancer or breast cancer.

Methods: This paper explores the possible association between the use of oral ALN in osteoporosis patients and subsequent cancer risk using the National Health Insurance (NHI) system database of Taiwan with a Cox proportional-hazard regression analysis. The exposure cohort contained 5,624 osteoporosis patients used ALN and randomly frequency-matched by age and gender of 3 osteoporosis patients without any kind of anti-osteoporosis drugs in the same period.

Results: For a dose ≥ 1.0 g/year, the risk of developing overall cancer was significantly higher (hazard ratio: 1.69, 95% confidence ratio: 1.39-2.04) than in osteoporosis patients without any anti-osteoporosis drugs. The risks for developing liver, lung, and prostate cancers and lymphoma were also significantly higher than in the control group.

Conclusions: This population-based retrospective cohort study did not find a relationship between ALN use and either esophageal or breast cancer, but unexpectedly discovered that use of ALN with dose ≥ 1.0 g/year significantly increased risks of overall cancer incidence, as well as liver, lung, and prostate cancers and lymphoma. Further large population-based unbiased studies to enforce our findings are required before any confirmatory conclusion can be made.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Alendronate / administration & dosage*
  • Alendronate / adverse effects*
  • Alendronate / therapeutic use
  • Bone Density Conservation Agents / administration & dosage*
  • Bone Density Conservation Agents / adverse effects*
  • Bone Density Conservation Agents / therapeutic use
  • Breast Neoplasms / chemically induced
  • Breast Neoplasms / epidemiology
  • Cohort Studies
  • Databases, Factual
  • Esophageal Neoplasms / chemically induced
  • Esophageal Neoplasms / epidemiology
  • Female
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Neoplasms / chemically induced
  • Neoplasms / epidemiology*
  • Osteoporosis / drug therapy*
  • Retrospective Studies
  • Risk
  • Taiwan

Substances

  • Bone Density Conservation Agents
  • Alendronate

Grants and funding

The study was supported in part by the study projects (DMR-101-061 and DMR-100-076) in the authors' hospital and the Taiwan Department of Health Clinical Trial and Research Center and for Excellence (DOH101-TD-B-111-004), and the Taiwan Department of Health Cancer Research Center for Excellence (DOH101-TD-C-111-005). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. No additional external funding received for this study