US2014256632A1PendingUtilityA1

Methods useful in the treatment of bone resorption diseases

63
Assignee: NPS PHARMA INCPriority: Jun 19, 1997Filed: May 22, 2014Published: Sep 11, 2014
Est. expiryJun 19, 2017(expired)· nominal 20-yr term from priority
Inventors:John DietrichSverker LjunghallSven Sjorgen
A61P 3/14A61P 5/18A61K 31/59A61K 31/56A61P 19/10A61K 31/138A61K 45/06A61P 19/02A61K 31/66A61K 31/452A61K 31/663A61K 38/29A61K 31/675A61P 19/08
63
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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  claim 1  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  claim 1  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  claim 1  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  claim 1  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  claim 1  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  claim 1  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  claim 1  wherein the said bone resorption inhibitor is a vitamin D analog. 
     
     
         17 . A preparation according to  claim 1  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  claim 18 , 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  claim 18  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  claim 18  wherein the said bone resorption inhibitor is at least one of the group consisting of a bisphosphonate, a substance with estrogen-like effect, a selective estrogen receptor modulator, a calcitonin-like substance, a vitamin D analog, and a calcium salt. 
     
     
         26 . The use according to  claim 18  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  claim 1 . 
     
     
         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  claim 27 , 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  claim 27 , 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  claim 27  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  claim 27  wherein the said bone resorption inhibitor is at least one of the group consisting of a bisphosphonate, a substance with estrogen-like effect, a selective estrogen receptor modulator, a calcitonin-like substance, a vitamin D analog, and a calcium salt. 
     
     
         37 . The method according to  claim 27  for the treatment of osteoporosis.

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