6/10/2023

Janusmed kön och genus

Janusmed kön och genus – Fosastad

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

För att komma till startsidan för Janusmed kön och genus och för att göra sökningar klicka här.

Tillbaka till index
A A
A A

Vitamin D

Vitamin D

Klass: A

Visa all info

Skriv ut

Kontakta oss

Produkter

Visa alla produkter

ADROVANCE, Alendronate/Cholecalciferol Accord, Benferol......

ADROVANCE, Alendronate/Cholecalciferol Accord, Benferol, Colecalciferol EQL Pharma, Colecalciferol Meda, Colecalciferol Strides, D3-Vicotrat, Dekristol Mibe, Detremin, Devitre, Divifarm, Divisun, Fosastad, Fosavance, Fultium, Kolekalciferol 2care4, Kolekalciferol Ebb, Kolekalciferol Evolan, Vigantol, Vitamin D3 Streuli
ATC-koder

A11CC05, M05BB03

A11CC05, M05BB03
Substanser

Visa alla substanser

dry vitamin d3 100 sd/s, kolekalciferol, kolekalciferol......

dry vitamin d3 100 sd/s, kolekalciferol, kolekalciferol (100 cws), kolekalciferol (basf), kolekalciferol (typ 50 cws/f)
Sammanfattning

Effekten av vitamin D för prevention av fallrisk och frakturer är likvärdig hos kvinnor och män.

Effekten av vitamin D för prevention av fallrisk och frakturer är likvärdig hos kvinnor och män.
Background

Pharmacokinetics and dosing
Vitamin D is inactive, metabolized by hydroxylation in the liver to 25(OH)D and subsequently metabolized in the kidney to 1,25(OH)D which represents the biologically active form [1]. A study of healthy volunteers (20 men, 35 women) randomized to 10 µg cholecalciferol in multivitamin tablets or in fish oil capsules showed a similar increase of 25(OH)D in both men and women after 4 weeks of supplementation [2].

Effects
Mortality

A meta-analysis of eight population based studies in Europe and USA with participants aged 50-79 years (12 842 men, 13 176 women) showed that the median 25(OH)D concentrations were higher in men than in women but the all-cause mortality risk was similar. According to the authors, low 25(OH)D concentrations might be a marker for a poor health status rather than a cause of premature mortality [3]. One of the studies included in this meta-analysis is an U.S. population based survey study with a household interview and a medical examination (7 399 men, 7 700 women) showing the lowest risk of mortality at different intervals of......

Visa hela bakgrundstexten

# Pharmacokinetics and dosing Vitamin D is inactive, metabolized by hydroxylation in the liver to 25(OH)D and subsequently metabolized in the kidney to 1,25(OH)D which represents the biologically active form [1]. A study of healthy volunteers (20 men, 35 women) randomized to 10 µg cholecalciferol in multivitamin tablets or in fish oil capsules showed a similar increase of 25(OH)D in both men and women after 4 weeks of supplementation [2]. # Effects **Mortality** A meta-analysis of eight population based studies in Europe and USA with participants aged 50-79 years (12 842 men, 13 176 women) showed that the median 25(OH)D concentrations were higher in men than in women but the all-cause mortality risk was similar. According to the authors, low 25(OH)D concentrations might be a marker for a poor health status rather than a cause of premature mortality [3]. One of the studies included in this meta-analysis is an U.S. population based survey study with a household interview and a medical examination (7 399 men, 7 700 women) showing the lowest risk of mortality at different intervals of 25(OH)D in men and women (100-119 vs 75-99 nmol/L). The risk of death was increased at levels <40 and >120 nmol/L in men, and at levels <75 and >100 nmol/L in women [4]. A prospective study of health of older adults aged ≥85 years (319 men, 526 women) showed that women but not men had an adjusted increased risk of all-cause mortality at concentrations of 25(OH)D <25 and ≥75 nmol/L (RR 1.6 and 1.5-1.9, repectively) [5]. **Cardiovascular (CVD)** In two longitudinal survey studies the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS) among US health professionals (51 529 men, 121 700 women), a high vitamin D intake from food and supplements reduced the risk of CVD by 0.84 in men, but not in women [6]. **Fall risk** A meta-analysis of pooled data from four studies of vitamin D plus calcium in 1 317 elderly (12% men, 88% women, approximately) showed no overall reduction of the fall risk (RR 0.99). However, in one of the studies in only women (148 women) [7] of vitamin D plus calcium vs calcium a reduced fall risk (RR 0.55) was shown [8]. **Fractures, Bone Mineral Density** In a double-blind placebo-controlled intervention study, Danish traditional Muslims (84 men, 89 women, 26 girls of median age 12 years) were randomized to placebo, vitamin D 10 µg or 20 µg daily. In the treatment group, the levels of 25(OH)D increased  (unspecified how much) in girls, 2-3 fold increase in men, and 4-fold in women. The levels of parathyroid hormone (PTH) were decreased in men, women and girls but no effect on markers of bone mass and bone turnover was noted at six months [9]. However, in a cross-sectional study, adolescents 12-15 years of age (111 boys, 111 girls) were randomized to regular diet or a daily supplement of vitamin D and calcium. Total body bone mineral density (BMD) increased with increasing levels of 25(OH)D up to a break-point of 39 nmol/L 25(OH)D in boys and 20 nmol/L 25(OH)D in girls. Above the break-point no further increase in bone mineral density was shown despite increasing levels of 25(OH)D [10]. **Hormones** **​​​​​​​**A clinical study (113 men, 33 women, 74 boys 5–6 years old) showed that women taking daily supplement of vitamin D in the autumn and winter had no seasonal decline in serum levels of Anti-Müllerian hormone (AMH), a sex hormone used as measure of fertility in women, and involved the development of male sex in fetuses [11]. # Adverse effects No studies with a clinical relevant sex analysis regarding adverse effects of vitamin D have been found. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information In the meta-analysis of eight population based studies in Europe and USA (12 842 men, 13 176 women) mentioned above median 25(OH)D showed that the 25(OH)D concentrations were higher in men than in women [3]. Contrary to this, in a world-wide meta-analysis of 105 studies in men and 277 studies in women (33 266 in all, unknown distribution of participants’ sex) found that women had higher mean levels of 25(OH)D than men (56 vs 50 nmol/L). One of the studies in the age group 70+ found a sufficient intake of 25(OH)D (>15 μg/day) from ordinary diet in 1–3% of men and in none of the women [12]. An open cross-over study, school children (409 boys, 373 girls) 8-11 years old were randomized to ordinary food or to the New Nordic Diet during three months. In the whole study group, the lowest levels of 25(OH)D were found in immigrant girls (80% regarded as deficient, ≤ 50 nmol/L), followed by immigrant boys (+9.4 nmol/L). Among native Danish children, the levels were even higher, with the boys having higher concentrations than the girls (+3.3 nmol/L) [13,14]. A randomized controlled study in 6-14 years old schoolchildren in Thailand (261 boys, 268 girls) showed that girls but not boys had a 4% decline in serum 25(OH)D levels for each increasing year of age. At the age 10 years old, the concentration of 25(OH)D was 19% higher in boys than in girls [15]. A multicenter study  in the Midwest in the US of 385 patients (20% men, 80% women, approximately) who had undergone surgical repair of a hip fracture showed that the median levels of 25(OH)D were higher in men than in women (16.9 vs 14.4 ng/ml) [16,17]. A prospective cohort study of data from a randomized clinical trial in hemodialysis patients (31 men, 21 women) during 4-5 weeks showed that patients’ sex, but not serum concentration of 25(OH)D, was a predictor of changes in parathyroid hormone (PTH). During the study period PTH decreased in men but increased in women (-61 vs +14 pg/mL) [18]. Another study of hemodialysis patients (48 men, 36 women) showed higher mean levels of 25(OH)D in men than in women (72 vs 47 nmol/L), this was also shown in multivariate analysis [19].
Försäljning på recept

Visa hela försäljning på recept

Fler kvinnor än män hämtade ut tabletter innehållande vitamin D (ATC-kod A11CC05) på recept i Sverige år 2015, totalt 70 453 kvinnor och 30 537 män. Det motsvarar 14,45 respektive 6,27 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 40-54 samt 85+ år hos kvinnor och i åldersgruppen 85+ år hos män. Totalt sett var tabletter innehållande vitamin D 2,3 gånger vanligare hos kvinnor [20].
Referenser

Visa referenser

  1. Food and Drug Administration. Clinical Pharmacology and Biopharmaceutics Review - FOSAMAX PLUS (alendronate and cholecalciferol). Food and Drug Administration [www]. [updated 2005-07-04, cited 2016-11-17].

  2. Holvik K, Madar AA, Meyer HE, Lofthus CM, Stene LC. A randomised comparison of increase in serum 25-hydroxyvitamin D concentration after 4 weeks of daily oral intake of 10 microg cholecalciferol from multivitamin tablets or fish oil capsules in healthy young adults. Br J Nutr. 2007;98:620-5.

  3. Schöttker B, Jorde R, Peasey A, Thorand B, Jansen EH, Groot Ld et al. Vitamin D and mortality: meta-analysis of individual participant data from a large consortium of cohort studies from Europe and the United States. BMJ. 2014;348:g3656.

  4. Sempos CT, Durazo-Arvizu RA, Dawson-Hughes B, Yetley EA, Looker AC, Schleicher RL et al. Is there a reverse J-shaped association between 25-hydroxyvitamin D and all-cause mortality? Results from the US nationally representative NHANES. J Clin Endocrinol Metab. 2013;98:3001-9.

  5. Granic A, Aspray T, Hill T, Davies K, Collerton J, Martin-Ruiz C et al. 25-hydroxyvitamin D and increased all-cause mortality in very old women: the Newcastle 85+ study. J Intern Med. 2015;277:456-67.

  6. Sun Q, Shi L, Rimm EB, Giovannucci EL, Hu FB, Manson JE et al. Vitamin D intake and risk of cardiovascular disease in US men and women. Am J Clin Nutr. 2011;94:534-42.

  7. Pfeifer M, Begerow B, Minne HW, Abrams C, Nachtigall D, Hansen C. Effects of a short-term vitamin D and calcium supplementation on body sway and secondary hyperparathyroidism in elderly women. J Bone Miner Res. 2000;15:1113-8.

  8. Latham NK, Anderson CS, Reid IR. Effects of vitamin D supplementation on strength, physical performance, and falls in older persons: a systematic review. J Am Geriatr Soc. 2003;51:1219-26.

  9. Andersen R, Mølgaard C, Skovgaard LT, Brot C, Cashman KD, Jakobsen J et al. Effect of vitamin D supplementation on bone and vitamin D status among Pakistani immigrants in Denmark: a randomised double-blinded placebo-controlled intervention study. Br J Nutr. 2008;100:197-207.

  10. Wu F, Laslett LL, Zhang Q. Threshold Effects of Vitamin D Status on Bone Health in Chinese Adolescents With Low Calcium Intake. J Clin Endocrinol Metab. 2015;100:4481-9.

  11. Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Müllerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012;97:2450-5.

  12. Hagenau T, Vest R, Gissel TN, Poulsen CS, Erlandsen M, Mosekilde L et al. Global vitamin D levels in relation to age, gender, skin pigmentation and latitude: an ecologic meta-regression analysis. Osteoporos Int. 2009;20:133-40.

  13. Damsgaard CT, Dalskov SM, Petersen RA, Sørensen LB, Mølgaard C, Biltoft-Jensen A et al. Design of the OPUS School Meal Study: a randomised controlled trial assessing the impact of serving school meals based on the New Nordic Diet. Scand J Public Health. 2012;40:693-703.

  14. Petersen RA, Damsgaard CT, Dalskov SM, Sørensen LB, Hjorth MF, Ritz C et al. Vitamin D status and its determinants during autumn in children at northern latitudes: a cross-sectional analysis from the optimal well-being, development and health for Danish children through a healthy New Nordic Diet (OPUS) School Meal Study. Br J Nutr. 2016;115:239-50.

  15. Houghton LA, Gray AR, Harper MJ, Winichagoon P, Pongcharoen T, Gowachirapant S et al. Vitamin D status among Thai school children and the association with 1,25-Dihydroxyvitamin D and parathyroid hormone levels. PLoS One. 2014;9:e104825.

  16. Pieper CF, Colon-Emeric C, Caminis J, Betchyk K, Zhang J, Janning C et al. Distribution and correlates of serum 25-hydroxyvitamin D levels in a sample of patients with hip fracture. Am J Geriatr Pharmacother. 2007;5:335-40.

  17. Harrington JT, Broy SB, Derosa AM, Licata AA, Shewmon DA. Hip fracture patients are not treated for osteoporosis: a call to action. Arthritis Rheum. 2002;47:651-4.

  18. Indridason OS, Pieper CF, Quarles LD. Predictors of short-term changes in serum intact parathyroid hormone levels in hemodialysis patients: role of phosphorus, calcium, and gender. J Clin Endocrinol Metab. 1998;83:3860-6.

  19. Del Valle E, Negri AL, Aguirre C, Fradinger E, Zanchetta JR. Prevalence of 25(OH) vitamin D insufficiency and deficiency in chronic kidney disease stage 5 patients on hemodialysis. Hemodial Int. 2007;11:315-21.

  20. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-11-08.]

  1. Food and Drug Administration. Clinical Pharmacology and Biopharmaceutics Review - FOSAMAX PLUS (alendronate and cholecalciferol). Food and Drug Administration [www]. [updated 2005-07-04, cited 2016-11-17].
  2. Holvik K, Madar AA, Meyer HE, Lofthus CM, Stene LC. A randomised comparison of increase in serum 25-hydroxyvitamin D concentration after 4 weeks of daily oral intake of 10 microg cholecalciferol from multivitamin tablets or fish oil capsules in healthy young adults. Br J Nutr. 2007;98:620-5.
  3. Schöttker B, Jorde R, Peasey A, Thorand B, Jansen EH, Groot Ld et al. Vitamin D and mortality: meta-analysis of individual participant data from a large consortium of cohort studies from Europe and the United States. BMJ. 2014;348:g3656.
  4. Sempos CT, Durazo-Arvizu RA, Dawson-Hughes B, Yetley EA, Looker AC, Schleicher RL et al. Is there a reverse J-shaped association between 25-hydroxyvitamin D and all-cause mortality? Results from the US nationally representative NHANES. J Clin Endocrinol Metab. 2013;98:3001-9.
  5. Granic A, Aspray T, Hill T, Davies K, Collerton J, Martin-Ruiz C et al. 25-hydroxyvitamin D and increased all-cause mortality in very old women: the Newcastle 85+ study. J Intern Med. 2015;277:456-67.
  6. Sun Q, Shi L, Rimm EB, Giovannucci EL, Hu FB, Manson JE et al. Vitamin D intake and risk of cardiovascular disease in US men and women. Am J Clin Nutr. 2011;94:534-42.
  7. Pfeifer M, Begerow B, Minne HW, Abrams C, Nachtigall D, Hansen C. Effects of a short-term vitamin D and calcium supplementation on body sway and secondary hyperparathyroidism in elderly women. J Bone Miner Res. 2000;15:1113-8.
  8. Latham NK, Anderson CS, Reid IR. Effects of vitamin D supplementation on strength, physical performance, and falls in older persons: a systematic review. J Am Geriatr Soc. 2003;51:1219-26.
  9. Andersen R, Mølgaard C, Skovgaard LT, Brot C, Cashman KD, Jakobsen J et al. Effect of vitamin D supplementation on bone and vitamin D status among Pakistani immigrants in Denmark: a randomised double-blinded placebo-controlled intervention study. Br J Nutr. 2008;100:197-207.
  10. Wu F, Laslett LL, Zhang Q. Threshold Effects of Vitamin D Status on Bone Health in Chinese Adolescents With Low Calcium Intake. J Clin Endocrinol Metab. 2015;100:4481-9.
  11. Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Müllerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012;97:2450-5.
  12. Hagenau T, Vest R, Gissel TN, Poulsen CS, Erlandsen M, Mosekilde L et al. Global vitamin D levels in relation to age, gender, skin pigmentation and latitude: an ecologic meta-regression analysis. Osteoporos Int. 2009;20:133-40.
  13. Damsgaard CT, Dalskov SM, Petersen RA, Sørensen LB, Mølgaard C, Biltoft-Jensen A et al. Design of the OPUS School Meal Study: a randomised controlled trial assessing the impact of serving school meals based on the New Nordic Diet. Scand J Public Health. 2012;40:693-703.
  14. Petersen RA, Damsgaard CT, Dalskov SM, Sørensen LB, Hjorth MF, Ritz C et al. Vitamin D status and its determinants during autumn in children at northern latitudes: a cross-sectional analysis from the optimal well-being, development and health for Danish children through a healthy New Nordic Diet (OPUS) School Meal Study. Br J Nutr. 2016;115:239-50.
  15. Houghton LA, Gray AR, Harper MJ, Winichagoon P, Pongcharoen T, Gowachirapant S et al. Vitamin D status among Thai school children and the association with 1,25-Dihydroxyvitamin D and parathyroid hormone levels. PLoS One. 2014;9:e104825.
  16. Pieper CF, Colon-Emeric C, Caminis J, Betchyk K, Zhang J, Janning C et al. Distribution and correlates of serum 25-hydroxyvitamin D levels in a sample of patients with hip fracture. Am J Geriatr Pharmacother. 2007;5:335-40.
  17. Harrington JT, Broy SB, Derosa AM, Licata AA, Shewmon DA. Hip fracture patients are not treated for osteoporosis: a call to action. Arthritis Rheum. 2002;47:651-4.
  18. Indridason OS, Pieper CF, Quarles LD. Predictors of short-term changes in serum intact parathyroid hormone levels in hemodialysis patients: role of phosphorus, calcium, and gender. J Clin Endocrinol Metab. 1998;83:3860-6.
  19. Del Valle E, Negri AL, Aguirre C, Fradinger E, Zanchetta JR. Prevalence of 25(OH) vitamin D insufficiency and deficiency in chronic kidney disease stage 5 patients on hemodialysis. Hemodial Int. 2007;11:315-21.
  20. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-11-08.]
Uppdaterat

Litteratursökningsdatum 9/15/2016

Litteratursökningsdatum 9/15/2016
A A
A A

Alendronat

Alendronat

Klass: A

Visa all info

Skriv ut

Kontakta oss

Produkter

Visa alla produkter

ADROVANCE, Alenat, Alenat Veckotablett, Alendronat Acco......

ADROVANCE, Alenat, Alenat Veckotablett, Alendronat Accord Veckotablett, Alendronat Actavis Veckotablett, Alendronat Aristo Veckotablett, Alendronat Arrow, Alendronat Arrow Veckotablett, Alendronat Aurobindo Veckotablett, Alendronat Bluefish Veckotablett, Alendronat Ebb Veckotablett, Alendronat MDS Veckotablett, Alendronat Mylan, Alendronat Mylan Veckotablett, Alendronat Orifarm Veckotablett, Alendronat Paranova Veckotablett, Alendronat Ranbaxy Veckotablett, Alendronat STADA, Alendronat STADA Veckotablett, Alendronat Sandoz Veckotablett, Alendronat Teva, Alendronat Teva Veckotablett, Alendronat Unimedic, Alendronat ratiopharm Veckotablett, Alendronate sodium, Alendronate/Cholecalciferol Accord, Alendronic Acid, Binosto, Fosamax, Fosamax Veckotablett, Fosastad, Fosavance
ATC-koder

M05BA04, M05BB03

M05BA04, M05BB03
Substanser

Visa alla substanser

alendronsyra, natriumalendronat, vattenfri, natriumalen......

alendronsyra, natriumalendronat, vattenfri, natriumalendronatmonohydrat, natriumalendronattrihydrat
Sammanfattning

Bisfosfonater ökar benmineraltätheten (BMD) lika effektivt och ger likartad lägre risk för fraktur hos både män och kvinnor..

En studie visade att kvinnor med postmenopausal hormonbehandling (HRT) och män hade lika bra effekt av 5 mg och 10 mg alendronat. I Sverige rekommenderas idag 10 mg/dag.

Det finns inte någon säkerställd könsskillnad i risken för atypiska femurfrakturer och käkosteonekros vid långtidsbehandling med bisfosfonater. Säkerhetspanoramat och risken för biverkningar vid långtidsbehandling med bisfosfonater hos män förefaller vara desamma som hos postmenopausala kvinnor.

Bisfosfonater ökar benmineraltätheten (BMD) lika effektivt och ger likartad lägre risk för fraktur hos både män och kvinnor.. En studie visade att kvinnor med postmenopausal hormonbehandling (HRT) och män hade lika bra effekt av 5 mg och 10 mg alendronat. I Sverige rekommenderas idag 10 mg/dag. Det finns inte någon säkerställd könsskillnad i risken för atypiska femurfrakturer och käkosteonekros vid långtidsbehandling med bisfosfonater. Säkerhetspanoramat och risken för biverkningar vid långtidsbehandling med bisfosfonater hos män förefaller vara desamma som hos postmenopausala kvinnor.
Background

Female sex is one of the risk factors for osteoporosis fragility fractures. The same type of fractures occurs in men and women with osteoporosis. Women are more prone to spinal fractures, due to a relatively abrupt bone density loss after menopause. Men have a higher peak bone mass (in general), and the bone density deteriorates more successively from the age of 40 [1].

Osteoporosis in men is largely underdiagnosed and undertreated. Also, in those men with a history of fractures and a high risk of new fractures. Although there are differences between men and women in the pathophysiology of osteoporosis, such as in the pattern of bone loss, similarities like clinical risk factors predominate. Drug approval for osteoporosis treatment in men has generally been based on small-scale bridging trials with bone mineral density (BMD) endpoint for substances previously shown to reduce fracture risk in postmenopausal osteoporosis [2, 3].

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 pos......

Visa hela bakgrundstexten

Female sex is one of the risk factors for osteoporosis fragility fractures. The same type of fractures occurs in men and women with osteoporosis. Women are more prone to spinal fractures, due to a relatively abrupt bone density loss after menopause. Men have a higher peak bone mass (in general), and the bone density deteriorates more successively from the age of 40 [1]. Osteoporosis in men is largely underdiagnosed and undertreated. Also, in those men with a history of fractures and a high risk of new fractures. Although there are differences between men and women in the pathophysiology of osteoporosis, such as in the pattern of bone loss, similarities like clinical risk factors predominate. Drug approval for osteoporosis treatment in men has generally been based on small-scale bridging trials with bone mineral density (BMD) endpoint for substances previously shown to reduce fracture risk in postmenopausal osteoporosis [2, 3]. # 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 [11]. 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 [12]. # Effects The mechanism of action of bisphosphonates is not believed to be different between men and women, and the results of bisphosphonate studies suggest similar efficacy in men and women [13]. 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 [12, 14, 15]. A meta-analysis (in total 375 men) reports that alendronate 10 mg/day decreases the risk of vertebral fractures in men to a similar extent as previously  observed in postmenopausal women (in total 12698 women) [16, 17]. # Adverse effects **Bisphosphonates** The data supporting the algorithm of long-term osteoporosis management with bisphosphonates, up to a total of 10 years, is described in a report by the American Society for Bone and Mineral Research (ASBMR) Task Force. The report stated that there is no evidence of sex differences in the risk of associated atypical femur fracture and osteonecrosis of the jaw from long-term bisphosphonate treatment. Men on long-term bisphosphonate therapy presumably have similar safety issues as postmenopausal women [4]. In a systematic review on the effect of anti-resorptive drugs on the development of medication-related osteonecrosis of the jaw in osteoporosis patients, patients’ sex was reported in 587 cases (38 men, 549 women). The majority of cases were found in women with a male-to-female ratio of 1:14 [5]. Another systematic review on medication-related osteonecrosis of the jaw from anti-resorptive drugs treatment found no significant interactions for patient’s sex (6 men, 53 women) [6]. The low number of men in these reviews does not allow any speculation on sex difference with regard to bisphosphonate-related osteonecrosis of the jaw.  In a survey sent to all oral and maxillofacial surgery clinics and hospital dental clinics in Sweden requesting reports of all new cases of bisphosphonate-related osteonecrosis of the jaw during 2007 and 2008, women accounted for 22 of the 26 oral bisphosphonate-related osteonecrosis of the jaw cases in 2007 and 25 of the 29 cases in 2008. Women were prescribed bisphosphonates 7.5 times more frequently than were men during 2007 and 2008 in Sweden. However, the number of men with osteonecrosis of the jaw was too few for a valid determination of the male incidence  [7].  Radiographs of Swedish women and men ≥55 years (n=5,342) with femoral shaft fractures during a 3-year period were reviewed. Atypical fractures were found in 12 men and 160 women. The age-adjusted relative risk (RR) of atypical fracture associated with bisphosphonate use was 55 (95% CI: 39-79) in women and 54 (CI: 15-92) in men. In bisphosphonate users, the risk of atypical fracture was higher in women than men (RR=3.1, CI:1.1-8.4) [8]. In a study evaluating oral bisphosphonates and reported clostridium difficile infection (CDI), CDI adverse drug reactions were more common for women (0.45% [93/20,586]) compared to men (0.25% [4/1568]) [9].  No sex differences were found in a population-based, international case-control study (134,475 men, 738,397 women) on the risk of valvulopathy among bisphosphonate users [10].   **Specific for alendronate** A review report that the safety profile of alendronate in osteoporotic men is similar to that previously reported in postmenopausal women [18]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (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 [19]. The ASBMR Task Force report stated that continued treatment with bone protective therapy is indicated in women taking glucocorticoids long-term in a dose >5 mg/day of oral prednisolone or equivalent. Men ≥50 years who are treated with long-term glucocorticoids >5mg/day are also at increased risk of fracture and may benefit from continuation of therapy [4]. In a Spanish population-based cohort study trends of use of anti-osteoporosis drugs were analyzed. Out of 1.5 million participants, 135,410 received anti-osteoporosis drug treatment during 2001–2013. Prevalence was higher in women (6.1%) compared to men (1.1%). The incidence rate (IR) was 24.90 in women and 2.77 in men. IRs were highest for bisphosphonates along the years (ranging 3.70–14.73 and 0.57–1.75 in women and men respectively) [20]. In an observational study using Hungarian national prescription data, male patients had disproportionately fewer bisphosphonate prescriptions for osteoporosis in all age groups [21].
Försäljning på recept

Visa hela försäljning på recept

Fler kvinnor än män hämtade ut tabletter innehållande alendronsyra (ATC-kod M05BA04) på recept i Sverige år 2019, totalt 62 938 kvinnor och 16 814 män. Det motsvarar 12 respektive 3 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 75 år och äldre hos båda könen. Totalt sett var tabletter innehållande alendronsyra 3,8 gånger vanligare hos kvinnor [22]. Hos individer över 50 år i Sverige har det uppskattats att 20 % av kvinnor och 2,5 % av män har behov av osteoporosläkemedel [23].
Referenser

Visa referenser

  1. Läkemedelsverket. Läkemedel vid osteoporos för att förhindra benskörhetsfrakturer - behandlingsrekommendation. Läkemedelsverket [www]. [updated 2020-04-30, cited 2020-06-11].

  2. Kaufman JM, Lapauw B, Goemaere S. Current and future treatments of osteoporosis in men. Best Pract Res Clin Endocrinol Metab. 2014;28(6):871-84.

  3. Adler RA. Update on osteoporosis in men. Best Pract Res Clin Endocrinol Metab. 2018;32(5):759-772.

  4. Adler RA, El-Hajj Fuleihan G, Bauer DC, Camacho PM, Clarke BL, Clines GA et al. Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2016;31(1):16-35.

  5. Aljohani S, Fliefel R, Ihbe J, Kühnisch J, Ehrenfeld M, Otto S. What is the effect of anti-resorptive drugs (ARDs) on the development of medication-related osteonecrosis of the jaw (MRONJ) in osteoporosis patients: A systematic review. J Craniomaxillofac Surg. 2017;45(9):1493-1502.

  6. Khominsky A, Lim M. "Spontaneous" medication-related osteonecrosis of the jaw; two case reports and a systematic review. Aust Dent J. 2018;63(4):441-454.

  7. Ulmner M, Jarnbring F, Törring O. Osteonecrosis of the jaw in Sweden associated with the oral use of bisphosphonate. J Oral Maxillofac Surg. 2014;72(1):76-82.

  8. Schilcher J, Koeppen V, Aspenberg P, Michaëlsson K. Risk of atypical femoral fracture during and after bisphosphonate use. Acta Orthop. 2015;86(1):100-7.

  9. McConeghy KW, Soriano MM, Danziger LH. A Quantitative Analysis of FDA Adverse Event Reports with Oral Bisphosphonates and Clostridium difficile. Pharmacotherapy. 2016;36(10):1095-1101.

  10. Coloma PM, de Ridder M, Bezemer I, Herings RM, Gini R, Pecchioli S et al. Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study. Osteoporos Int. 2016;27(5):1857-67.

  11. 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.

  12. 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.

  13. Bonnick SL. Osteoporosis in men and women. Clin Cornerstone. 2006;8:28-39.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Ringe JD, Orwoll E, Daifotis A, Lombardi A. Treatment of male osteoporosis: recent advances with alendronate. Osteoporos Int. 2002;13:195-9.

  19. 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.

  20. Martín-Merino E, Huerta-Álvarez C, Prieto-Alhambra D, Montero-Corominas D. Cessation rate of anti-osteoporosis treatments and risk factors in Spanish primary care settings: a population-based cohort analysis. Arch Osteoporos. 2017;12(1):39.

  21. Bor A, Matuz M, Gyimesi N, Biczók Z, Soós G, Doró P. Gender inequalities in the treatment of osteoporosis. Maturitas. 2015;80(2):162-9.

  22. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.]

  23. 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.

  1. Läkemedelsverket. Läkemedel vid osteoporos för att förhindra benskörhetsfrakturer - behandlingsrekommendation. Läkemedelsverket [www]. [updated 2020-04-30, cited 2020-06-11].
  2. Kaufman JM, Lapauw B, Goemaere S. Current and future treatments of osteoporosis in men. Best Pract Res Clin Endocrinol Metab. 2014;28(6):871-84.
  3. Adler RA. Update on osteoporosis in men. Best Pract Res Clin Endocrinol Metab. 2018;32(5):759-772.
  4. Adler RA, El-Hajj Fuleihan G, Bauer DC, Camacho PM, Clarke BL, Clines GA et al. Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2016;31(1):16-35.
  5. Aljohani S, Fliefel R, Ihbe J, Kühnisch J, Ehrenfeld M, Otto S. What is the effect of anti-resorptive drugs (ARDs) on the development of medication-related osteonecrosis of the jaw (MRONJ) in osteoporosis patients: A systematic review. J Craniomaxillofac Surg. 2017;45(9):1493-1502.
  6. Khominsky A, Lim M. "Spontaneous" medication-related osteonecrosis of the jaw; two case reports and a systematic review. Aust Dent J. 2018;63(4):441-454.
  7. Ulmner M, Jarnbring F, Törring O. Osteonecrosis of the jaw in Sweden associated with the oral use of bisphosphonate. J Oral Maxillofac Surg. 2014;72(1):76-82.
  8. Schilcher J, Koeppen V, Aspenberg P, Michaëlsson K. Risk of atypical femoral fracture during and after bisphosphonate use. Acta Orthop. 2015;86(1):100-7.
  9. McConeghy KW, Soriano MM, Danziger LH. A Quantitative Analysis of FDA Adverse Event Reports with Oral Bisphosphonates and Clostridium difficile. Pharmacotherapy. 2016;36(10):1095-1101.
  10. Coloma PM, de Ridder M, Bezemer I, Herings RM, Gini R, Pecchioli S et al. Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study. Osteoporos Int. 2016;27(5):1857-67.
  11. 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.
  12. 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.
  13. Bonnick SL. Osteoporosis in men and women. Clin Cornerstone. 2006;8:28-39.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. Ringe JD, Orwoll E, Daifotis A, Lombardi A. Treatment of male osteoporosis: recent advances with alendronate. Osteoporos Int. 2002;13:195-9.
  19. 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.
  20. Martín-Merino E, Huerta-Álvarez C, Prieto-Alhambra D, Montero-Corominas D. Cessation rate of anti-osteoporosis treatments and risk factors in Spanish primary care settings: a population-based cohort analysis. Arch Osteoporos. 2017;12(1):39.
  21. Bor A, Matuz M, Gyimesi N, Biczók Z, Soós G, Doró P. Gender inequalities in the treatment of osteoporosis. Maturitas. 2015;80(2):162-9.
  22. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.]
  23. 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.
Uppdaterat

Litteratursökningsdatum 6/11/2020

Litteratursökningsdatum 6/11/2020