US2002002135A1PendingUtilityA1

Pharmaceutical use

50
Priority: Jun 19, 1997Filed: Aug 31, 2001Published: Jan 3, 2002
Est. expiryJun 19, 2017(expired)· nominal 20-yr term from priority
Inventors:John DietrichSverker LjunghallSven Sjogren
A61P 5/18A61P 3/14A61K 31/675A61K 31/59A61P 19/08A61P 19/02A61K 31/138A61K 31/66A61K 31/663A61K 31/452A61P 19/10A61K 31/56A61K 45/06A61K 38/29
50
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Claims

Abstract

The invention relates to a combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor, said preparation being adapted for (a) the administration of parathyroid hormone during a period of approximately 6 to 24 months; (b) after the administration of parathyroid hormone has been terminated, the administration of a bone resorption inhibitor during a period of approximately 12 to 36 months.

Claims

exact text as granted — not AI-modified
1 . A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor, said preparation being adapted for (a) the administration of parathyroid hormone during a period of approximately 6 to 24 months; and (b) after the administration of said parathyroid hormone has been terminated, the administration of a bone resorption inhibitor during a period of approximately 6 to 36 months.  
     
     
         2 . A combined pharmaceutical preparation according to  claim 1 , adapted for said administration of parathyroid hormone for approximately 12 to 24 months.  
     
     
         3 . A combined pharmaceutical preparation according to  claim 2 , adapted for said administration of parathyroid hormone for approximately 18 months.  
     
     
         4 . A combined pharmaceutical preparation according to any one of  claims 1  to  3 , adapted for said administration of bone resorption inhibitor for approximately 12 to 36 months.  
     
     
         5 . A combined pharmaceutical preparation according to  claim 4 , adapted for said administration of bone resorption inhibitor for approximately 12 to 18 months.  
     
     
         6 . A combined pharmaceutical preparation according to  claim 5 , adapted for said administration of bone resorption inhibitor for approximately 12 months.  
     
     
         7 . A preparation according to any one of  claims 1  to  6  wherein the said parathyroid hormone is selected from the group consisting of: 
 (a) full-length parathyroid hormone;  
 (b) biologically active variants of full-length parathyroid hormone;  
 (c) biologically active parathyroid hormone fragments; and  
 (d) biologically active variants of parathyroid hormone fragments.  
 
     
     
         8 . A preparation according to any one of  claims 1  to  7  wherein the said bone resorption inhibitor is a bisphosphonate.  
     
     
         9 . A preparation according to  claim 8  wherein the said bisphosphonate is alendronate.  
     
     
         10 . A preparation according to any one of  claims 1  to  7  wherein the said bone resorption inhibitor is a substance with estrogen-like effect.  
     
     
         11 . A preparation according to  claim 10  wherein the said substance with estrogen-like effect is estrogen.  
     
     
         12 . A preparation according to any one of  claims 1  to  7  wherein the said bone resorption inhibitor is a selective estrogen receptor modulator.  
     
     
         13 . A preparation according to  claim 12  wherein the said selective estrogen receptor modulator is selected from the group consisting of raloxifene, tamoxifene, droloxifene, toremifene. idoxifene, or levormeloxifene  
     
     
         14 . A preparation according to any one of  claims 1  to  7  wherein the said bone resorption inhibitor is a calcitonin-like substance.  
     
     
         15 . A preparation according to  claim 14  wherein the said calictonin-like substance is calcitonin.  
     
     
         16 . A preparation according to any one of  claims 1  to  7  wherein the said bone resorption inhibitor is a vitamin D analog.  
     
     
         17 . A preparation according to any one of  claims 1  to  7  wherein the said bone resorption inhibitor is a calcium salt.  
     
     
         18 . Use of parathyroid hormone in combination with a bone resorption inhibitor in the manufacture of a medicament for the treatment or prevention of bone-related diseases, said medicament being adapted for (a) the administration of parathyroid hormone during a period of approximately 6 to 24 months; (b) after the administration of parathyroid hormone has been terminated, the administration of a bone resorption inhibitor during a period of approximately 12 to 36 months.  
     
     
         19 . The use according to  claim 18 , wherein said medicament is adapted for administration of parathyroid hormone for approximately 12 to 24 months.  
     
     
         20 . The use according to  claim 19  wherein said medicament is adapted for administration of parathyroid hormone for approximately 18 months.  
     
     
         21 . The use according to any one of  claims 18  to  20 , wherein said medicament is adapted for administration of bone resorption inhibitor for approximately 12 to 36 months.  
     
     
         22 . The use according to  claim 21 , adapted for said administration of bone resorption inhibitor for approximately 12 to 18 months.  
     
     
         23 . The use according to  claim 22 , adapted for said administration of bone resorption inhibitor for approximately 12 months.  
     
     
         24 . The use according to any one of  claims 18  to  23  wherein the said parathyroid hormone is selected from 
 (a) full-length parathyroid hormone;  
 (b) biologically active variants of full-length parathyroid hormone;  
 (c) biologically active parathyroid hormone fragments; and  
 (d) biologically active variants of parathyroid hormone fragments.  
 
     
     
         25 . The use according to any one of  claims 18  to  24  wherein the said bone resorption inhibitor is as defined in any one of  claims 8  to  17 .  
     
     
         26 . The use according to any one of  claims 18  to  25  in the manufacture of a medicament for the treatment of osteoporosis.  
     
     
         27 . A method of treatment or prevention of bone-related diseases which comprises administering to a mammal, including man, in need of such treatment an effective amount of a pharmaceutical preparation according to any one of claims I to  17 .  
     
     
         28 . A method of treatment or prevention of bone-related diseases which comprises administering to a mammal, including man, in need of such treatment (a) an effective amount of parathyroid hormone during a period of approximately 6 to 24 months; and (b) after the administration of parathyroid hormone has been terminated, an effective amount of a bone resorption inhibitor during a period of approximately 6 to 36 months.  
     
     
         29 . A method of treatment or prevention of bone-related diseases which comprises administering, to a patient who has already been subject to treatment with parathyroid hormone during a period of approximately 6 to 24 months, after the administration of parathyroid hormone has been terminated, an effective amount of a bone resorption inhibitor during a period of approximately 6 to 36 months.  
     
     
         30 . A method of treatment or prevention of bone-related diseases according to any one of  claims 27  to  29 , adapted for said administration of parathyroid hormone for approximately 12 to 24 months.  
     
     
         31 . A method of treatment or prevention of bone-related diseases according to  claim 30 , adapted for said administration of parathyroid hormone for approximately  18  months.  
     
     
         32 . A method of treatment or prevention of bone-related diseases according to any one of  claims 27  to  31 , adapted for said administration of bone resorption inhibitor for approximately 12 to 36 months.  
     
     
         33 . A method of treatment or prevention of bone-related diseases according to  claim 32 , adapted for said administration of bone resorption inhibitor for approximately 12 to 18 months.  
     
     
         34 . A method of treatment or prevention of bone-related diseases according to  claim 33 , adapted for said administration of bone resorption inhibitor for approximately 12 months.  
     
     
         35 . The method according to any one of  claims 27  to  34  wherein the said parathyroid hormone is selected from 
 (a) full-length parathyroid hormone;  
 (b) biologically active variants of full-length parathyroid hormone;  
 (c) biologically active parathyroid hormone fragments; and  
 (d) biologically active variants of parathyroid hormone fragments .  
 
     
     
         36 . The method according to any one of  claims 27  to  35  wherein the said bone resorption inhibitor is as defined in any one of  claims 8  to  17 .  
     
     
         37 . The method according to any one of  claims 27  to  36  for the treatment of osteoporosis.

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