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Alendronic Acid: Carcinogenicity/Tumorigenicity: In a 2-year oral carcinogenicity study, parafollicular cell (thyroid) adenomas were increased in high-dose male rats at doses of 1 and 3.75 mg/kg body weight. These doses are equivalent to approximately 0.3 and 1 times a 40 mg human daily dose based on surface area, mg/m2.
Mutagenicity: Alendronic acid was not genotoxic in the in vitro microbial mutagenesis assay with and without metabolic activation. In an in vitro chromosomal aberration assay in Chinese hamster ovary cells, however, alendronic acid was weakly positive at concentrations ≥5 mM in the presence of cytotoxicity.
Use in Children: Safety and efficacy have not been established. Alendronic acid is not indicated for use in children.
Use in Elderly: In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronic acid. Therefore no dosage adjustment is necessary for the elderly.
