Treatment or prevention of menopausal symptoms and osteoporosis

Abstract

There is described a method for the treatment or prevention of menopausal symptoms or osteoporosis wherein there is administered to a subject in need of such treatment a therapeutically effective amount of the isoflavone formononetin, or a method for the treatment or prevention of menopausal symptoms wherein there is administered to a subject in need of such treatment a therapeutically effective amount of the isoflavone daidzein, the isoflavone being optionally administered with one or more pharmaceutically acceptable adjuvants, carriers and/or excipients. Therapeutic uses and compositions/foods are also described, comprising daidzein or formononetin optionally in association with one or more pharmaceutically acceptable adjuvants, carriers, food components and/or excipients.

1 . A method for the treatment or prevention of menopausal symptoms or osteoporosis wherein there is administered to a subject in need of such treatment a therapeutically effective amount of the isoflavone formononetin, or a method for the treatment or prevention of menopausal symptoms wherein there is administered to a subject in need of such treatment a therapeutically effective amount of the isoflavone daidzein, the isoflavone being optionally administered with one or more pharmaceutically acceptable adjuvants, carriers and/or excipients.  
     
     
         2 . A method according to  claim 1  for the treatment or prevention of osteoporosis.  
     
     
         3 . A method according to  claim 2  wherein formononetin is administered to a subject.  
     
     
         4 . A method according to  claim 1  for the treatment or prevention of menopausal symptoms.  
     
     
         5 . A method according to  claim 4  wherein formononetin or daidzein is administered to a patient.  
     
     
         6 . A method according to  claim 1 , wherein the isoflavone is present in an amount of at least 90% (w/w) as against any other isoflavones.  
     
     
         7 . A method according to  claim 1 , wherein the isoflavone is administered at least once per day.  
     
     
         8 . A method according to  claim 1 , wherein the isoflavone is administered in an amount from about 5 mg/day through to about 400 mg/day.  
     
     
         9 . A method according to  claim 1 , wherein the isoflavone is administered from 1 to 6 times in a 24 hour period so as to give a daily dosage of from about 5 to about 400 mg.  
     
     
         10 . A method according to  claim 1  wherein maid isoflavone is derived from a plant extract comprising daidzein and/or formononetin substantially unaccompanied by other isoflavones.  
     
     
         11 . A method according to  claim 1  for the treatment or prevention of osteoporosis wherein a combination of formononetin and daidzein is administered to a patient.  
     
     
         12 . A method according to  claim 1  wherein the isoflavone is substantially unaccompanied by other isoflavones.  
     
     
         13 . A method according to  claim 1  wherein daidzein is replaced by a daidzein metabolite selected from equol, o-desmethylangolensin (ODMA), dehydroequol, 2-dehydro ODMA, 6-hydroxy-ODMA, dihydrodaidzein and tetra-hydrodaidzein.  
     
     
         14 . A pharmaceutical composition for the treatment or prevention of menopausal symptoms or osteoporosis where the said composition comprises the isoflavone formononetin or a pharmaceutical composition for the treatment or prevention of menopause wherein said composition comprises the isoflavone daidzein, together with one or more pharmaceutically acceptable adjuvants, carriers and/or excipients.  
     
     
         15 . A composition according to  claim 14 , which is a composition for the treatment or prevention of osteoporosis.  
     
     
         16 . A composition according to  claim 15  which includes the isoflavone formononetin.  
     
     
         17 . A composition according to  claim 14  which is a composition for the treatment and/or prevention of acute menopausal symptoms.  
     
     
         18 . A composition according to  claim 17  wherein the isoflavone is daidzein or formononetin.  
     
     
         19 . A composition according to  claim 17  which includes a combination of daidzein and formononetin.  
     
     
         20 . A composition according to  claim 14  which comprises from 5 to 400 mg of isoflavone.  
     
     
         21 . A composition according to  claim 14  wherein daidzein is replaced by a daidzein metabolite selected from equol, o-desmethylangolensin (ODMA), dehydroequol, 2-dehydro-ODMA, 6-hydroxy-ODMA, dihydrodaidzein and tetra-hydrodaidzein.  
     
     
         22 . Use of the isoflavone formononetin in the treatment or prevention of menopausal symptoms or osteoporosis, or use of the isoflavone daidzein in the treatment or prevention of menopausal symptoms, the isoflavone being optionally administered with one or more pharmaceutically acceptable adjuvants, carriers, and/or excipients.  
     
     
         23 . Use according to  claim 22 , wherein the isoflavone is administered in an amount from about 5 mg to about 400 mg.  
     
     
         24 . Use according to  claim 22  for the treatment or prevention of osteoporosis wherein the isoflavone is formononetin.  
     
     
         25 . Use according to  claim 22  for the treatment or menopausal symptoms wherein the isoflavone is formononetin or daidzein.  
     
     
         26 . Use according to  claim 25  wherein a combination of daidzein and formononetin are administered to a subject.  
     
     
         27 . Use of formononetin, for the manufacture of a medicament for the treatment or prevention of menopausal symptoms or osteoporosis, or use of daidzein or formononetin for the manufacture of a medicament for the treatment or prevention of osteoporosis.  
     
     
         28 . Use according to  claim 22  wherein the daidzein or formononetin is administered from 1 to 6 times in a 24 hour period so as to give a daily dosage of about 5 mg to about 400 mg.  
     
     
         29 . Use according to  claim 27  wherein the isoflavone daidzein is combined with formononetin.  
     
     
         30 . An agent for the treatment or prevention of menopausal symptoms or osteoporosis which comprises formononetin, or an agent for the treatment or prevention of menopausal symptoms which comprises daidzein, optionally in association with one or more pharmaceutically acceptable adjuvants, carriers and/or excipients.  
     
     
         31 . A method or composition according to  claim 1  or  14 , wherein the isoflavone daidzein is in the aglycone, glycoside, malonyl or acetyl form.