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Alendronic acid

Classification: A

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

Summary

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.

Additional information

Pharmacokinetics and dosing

A series of clinical trials (in total 16 men, 132 women) found that the bioavailability of alendronate is similar in men and postmenopausal women [1]. 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 [2].

Effects

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 [3].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].

Adverse effects

A review report that the safety profile of alendronate in osteoporotic men is similar to that previously reported in postmenopausal women [8].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

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 [9].

Updated: 2019-02-26

Date of litterature search: 2014-07-30

References

  1. Gertz BJ, Holland SD, Kline WF, Matuszewski BK, Freeman A, Quan H et al. Studies of the oral bioavailability of alendronate. Clin Pharmacol Ther. 1995;58:288-98. PubMed
  2. Saag KG, Emkey R, Schnitzer TJ, Brown JP, Hawkins F, Goemaere S et al. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med. 1998;339:292-9. PubMed
  3. Bonnick SL. Osteoporosis in men and women. Clin Cornerstone. 2006;8:28-39. PubMed
  4. Ho YV, Frauman AG, Thomson W, Seeman E. Effects of alendronate on bone density in men with primary and secondary osteoporosis. Osteoporos Int. 2000;11:98-101. PubMed
  5. Iwamoto J, Takeda T, Sato Y, Uzawa M. Comparison of the effect of alendronate on lumbar bone mineral density and bone turnover in men and postmenopausal women with osteoporosis. Clin Rheumatol. 2007;26:161-7. PubMed
  6. Sawka AM, Papaioannou A, Adachi JD, Gafni A, Hanley DA, Thabane L. Does alendronate reduce the risk of fracture in men? A meta-analysis incorporating prior knowledge of anti-fracture efficacy in women. BMC Musculoskelet Disord. 2005;6:39. PubMed
  7. Cranney A, Wells G, Willan A, Griffith L, Zytaruk N, Robinson V et al. Meta-analyses of therapies for postmenopausal osteoporosis II Meta-analysis of alendronate for the treatment of postmenopausal women. Endocr Rev. 2002;23:508-16. PubMed
  8. Ringe JD, Orwoll E, Daifotis A, Lombardi A. Treatment of male osteoporosis: recent advances with alendronate. Osteoporos Int. 2002;13:195-9. PubMed
  9. Devold HM, Furu K, Skurtveit S, Tverdal A, Falch JA, Sogaard AJ. Influence of socioeconomic factors on the adherence of alendronate treatment in incident users in Norway. Pharmacoepidemiol Drug Saf. 2012;21:297-304. PubMed
  10. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk
  11. Svedbom A, Hernlund E, Ivergård M, Compston J, Cooper C, Stenmark J et al. Osteoporosis in the European Union: a compendium of country-specific reports. Arch Osteoporos. 2013;8:137. PubMed

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson