Drug products: ADROVANCE, Alenat, Alenat Veckotablett, Alendronat Accord Veckotablett, Alendronat Actavis Veckotablett, Alendronat Arrow, Alendronat Arrow Veckotablett, Alendronat Aurobindo Veckotablett, Alendronat Bluefish Veckotablett, Alendronat MDS Veckotablett, Alendronat Mylan, Alendronat Mylan Veckotablett, Alendronat Orifarm Veckotablett, Alendronat Ranbaxy Veckotablett, Alendronat ratiopharm Veckotablett, Alendronat Sandoz Veckotablett, Alendronat STADA, Alendronat STADA Veckotablett, Alendronat Teva, Alendronat Teva Veckotablett, Alendronat Unimedic, Alendronic Acid, Fosamax, Fosamax Veckotablett, Fosamax®, Fosamax® mite, Fosamax® Veckotablett, Fosastad, Fosavance®
ATC code: M05BA04, M05BB03
Substances: alendronic acid
Bisphosphonates increase the bone mineral density (BMD) as efficiently and give a comparable lower risk of fracture in men and women.
One clinical trial showed similar efficacy on increased bone mineral density with 5 and 10 mg of alendronate in men and postmenopausal women with hormonal replacement therapy. However, in postmenopausal women without hormonal replacement therapy, the 10 mg dose was more effective. In Sweden the recommended dose is 10 mg/day.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
A series of clinical trials (in total 16 men, 132 women) found that the bioavailability of alendronate is similar in men and postmenopausal women . One clinical trial (141 men, 336 women) showed similar efficacy on increased BMD (bone mineral density) with 5 and 10 mg of alendronate in men and postmenopausal women with hormonal replacement therapy. In postmenopausal women without hormonal replacement therapy, the 10 mg dose was more effective .
The mechanism of action of bisphosphonates is not believed to be different between men and women, and the results of bisphosphonate studies suggest that these agents each should have efficacy in men similar to their efficacy in women .Data from placebo-controlled clinical trials in primary and glucocorticoid-induced osteoporosis show an increase in lumbar spine BMD in men and women after 12 months of treatment with alendronate 10 mg/day [2, 4, 5].A meta-analysis (in total 375 men) report that alendronate 10 mg/day decrease the risk of vertebral fractures in men to a similar extent that previously has been observed in a meta-analysis of data from postmenopausal women (in total 12698 women) [6, 7].
A review report that the safety profile of alendronate in osteoporotic men is similar to that previously reported in postmenopausal women .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
A Norwegian study (1010 men, 6600 women) examined the influence of socioeconomic factors on adherence of alendronate drug treatment in patients 40-79 years old. In women, the most important factors for being adherent were age 60 years or more and high income. In men, a middle educational level predicted adherence. Previous marriage reduced the odds of being adherent in both women and men .
Date of litterature search: 2014-07-30
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson