Methods for treatment of prader-willi syndrome

Abstract

A method for treating Prader-Willi syndrome (PWS)-induced bone loss in a pediatric subject includes administering to the subject a therapeutically effective amount of a fatty acid amide of an amino acid, or a stereoisomer or salt thereof. Pharmaceutical compositions including a fatty acid amide of an amino acid, such as oleoyl-α-methyl-serine, or a stereoisomer or salt thereof, can be used for improving, i.e., increasing or preventing loss of, bone mineral density and/or treating osteoporosis in patients suffering from Prader-Willi syndrome.

What is claimed is: 
     
         1 . A method for treating Prader-Willi syndrome (PWS)-induced bone loss in a pediatric subject, said method comprising administering to said subject a therapeutically effective amount of a fatty acid amide of an amino acid, or a stereoisomer or salt thereof,
 wherein said fatty acid amide of an amino acid is of the formula I:   
       
         
           
           
               
               
           
         
         or a stereoisomer or salt thereof, 
         wherein: 
         R 4  is —OH, —SH, phenyl, or hydroxyphenyl; 
         R 5  is H, (C 1 -C 6 )alkyl or —OR 3 ; 
         R 6  is a group of the formula II: 
       
       
         
           
           
               
               
           
         
         R 10  is (C 11 -C 21 )alkyl, (C 11 -C 21 )alkenyl, or (C 11 -C 21 )alkynyl; 
         R 11  and R 12  each independently is H, (C 1 -C 6 )alkyl —OR), or —SR 2 ; and 
         R 1 , R 2 , and R 3  each independently is H or (C 1 -C 6 )alkyl. 
       
     
     
         2 . The method of  claim 1 , wherein R 4  is —OH. 
     
     
         3 . The method of  claim 1 , wherein R 10  is (C 11 -C 21 )alkenyl. 
     
     
         4 . The method of  claim 3 , wherein R 10  is (Cis)alkenyl. 
     
     
         5 . The method of  claim 4 , wherein R 10  is —(CH 2 ) 5 —CH═CH—(CH 2 ) 7 —CH 3 . 
     
     
         6 . The method of  claim 1 , wherein R 4  is —OH; R 5  is H or (C 1 -C 6 )alkyl; R 10  is (C 11 -C 21 )alkenyl; and R 11  and R 12  each independently is H or (C 1 -C 6 )alkyl. 
     
     
         7 . The method of  claim 4 , wherein R 10  is —(CH 2 ) 5 —CH═CH—(CH 2 ) 7 —CH 3 . 
     
     
         8 . The method of  claim 1 , wherein said (C 1 -C 6 )alkyl is methyl, ethyl, or isopropyl. 
     
     
         9 . The method according to  claim 1 , further comprising administering an additional active agent. 
     
     
         10 . The method according to  claim 10 , wherein said active agent is a bisphosphonate, hormone, anti-receptor activator of nuclear factor kappa-B ligand, cathepsin K inhibitor, or anti-sclerostin antibody.