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Can weekly alendronic acid prevent osteoporotic fractures in men?

Osteoporosis is a growing problem in men — up to 30% of all hip fractures occur in men and the incidence is thought to be increasing due to the ageing population. However, the cause of the condition is not as clear for men as it is for women. Factors contributing to the development of osteoporosis in men include corticosteroid use, androgen deprivation therapy and hypogonadism. Although there is no specific guidance on the diagnosis of male osteoporosis, the World Health Organization suggests that the criteria for the diagnosis of women are suitable for use in men.

In the UK, alendronic acid is licensed for the prevention of osteoporotic fractures and bone loss in women at doses of 10mg daily or 70mg weekly. However, only the daily formulation is licensed for use in men, and the drug is not indicated for prophylaxis against male bone loss at any dose. National Institute for Health and Clinical Excellence guidance, and guidance from the WHO, around the use of alendronic acid applies only to women.

Evidence suggests that alendronic acid is effective in men, although possibly not to the same extent as in postmenopausal women.

Studies have shown that alendronic acid 70mg weekly can increase bone mineral density in men and can help prevent bone loss associated with androgen deprivation therapy. However, the studies have limitations, including the fact that they recruited a small number of participants, most of whom were Caucasian. Moreover, all the studies used bone mineral density as a surrogate measure of fracture risk. In the US the weekly dose is licensed for use in men with osteoporosis to increase bone mass.

Another consideration is that the strict and inconvenient administration requirements for alendronic acid mean that reducing administration from daily to weekly may improve adherence. Weekly administration is also slightly cheaper than the daily regimen.

Citation: Clinical Pharmacist URI: 11108203

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