Assessment of DNA damage in postmenopausal women under osteoporosis therapy

Eur J Obstet Gynecol Reprod Biol. 2006 Aug;127(2):227-30. doi: 10.1016/j.ejogrb.2006.01.027. Epub 2006 Feb 28.


Objective: The following study was designed to examine possible DNA damage levels in peripheral blood leukocytes, using the alkaline Comet assay, isolated from postmenopausal women undergoing osteoporosis treatment.

Study design: Thirty-two postmenopausal women were randomized into two groups of 16. A dosage of 2.5 mg/day of tibolone (Livial) and 10mg/day of alendronate sodium (Fosamax) were administered to Group 1 over a 12-month period while Group 2 took 10 mg/day of alendronate alone over the same period. The control group consisted of 16 postmenopausal women who did not receive any treatment. Genotoxicity was assessed by the standard method of alkaline Comet assay.

Results: When the results of the study groups were compared with those of the control group, significant differences in terms of DNA damage levels were found (p<0.05). However, no difference was detected between Groups 1 and 2 (p>0.05).

Conclusion: Although, no statistical difference in terms of DNA damage levels between tibolone plus alendronate as opposed to alendronate alone was found, an increase in DNA damage levels was observed in Groups 1 and 2 compared with the control group. Consequently, it can be asserted that the frequency of DNA damage in postmenopausal women with osteoporosis increases under alendronate treatment with or without tibolone.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Alendronate / therapeutic use*
  • Bone Density Conservation Agents / therapeutic use*
  • Comet Assay
  • DNA / drug effects
  • DNA Damage* / drug effects
  • Drug Therapy, Combination
  • Female
  • Humans
  • Middle Aged
  • Norpregnenes / therapeutic use*
  • Osteoporosis, Postmenopausal / drug therapy*


  • Bone Density Conservation Agents
  • Norpregnenes
  • DNA
  • tibolone
  • Alendronate