Claims for Patent: 4,588,716

Summary for Patent: 4,588,716

Title:	Method for treating metabolic bone disease in mammals
Abstract:	A method for treating or preventing metabolic bone disease characterized by loss of bone mass in mammals by administering 24-epi-1.alpha.,25-dihydroxy vitamin D.sub.2 alone or in combinations thereof with bone mobilization-inducing vitamin D derivatives to said mammals.
Inventor(s):	DeLuca; Hector F. (Madison, WI), Schnoes; Heinrich K. (Madison, WI)
Assignee:	Wisconsin Alumni Research Foundation (Madison, WI)
Application Number:	06/691,824
Patent Claims:	1. A method for preventing or treating physiological disorders in mammals, which disorders are characterized by a requirement to regenerate or prevent loss of bone mass, which comprises administering to said mammals an amount of 1 alpha,25-dihydroxy-24-epi vitamin D.sub.2 sufficient to induce mineralization of bone and thereby to increase or prevent loss of net bone mass. 2. The method of claim 1 wherein the disorder is postmenopausal osteoporosis. 3. The method of claim 1 wherein the disorder is involutional osteoporosis. 4. The method of claim 1 wherein the disorder is senile osteoporosis. 5. The method of claim 1 wherein the disorder is steroid-induced osteoporosis. 6. The method of claim 2 wherein the compound is administered to women during and subsequent to menopause. 7. The method of claim 2 wherein the compound is administered to women prior to the onset of menopause. 8. The method of claim 1 wherein the compound is administered in an amount from about 0.5 microgram to about 25 micrograms per day. 9. The method of claim 1 wherein the compound, in solution in a liquid vehicle ingestible by and nontoxic to said mammals is administered orally in encapsulated form. 10. The method of claim 1 wherein 1.alpha.,25-dihydroxy-24-epi vitamin D.sub.2 is administered in combination with at least one hormone or vitamin D compound characterized by the ability to mobilize bone in vivo. 11. The method of claim 10 where the bone mobilization-inducing compound is selected from parathyroid hormone vitamin D.sub.3, vitamin D.sub.2 1.alpha.-hydroxyvitamin D.sub.3, 1.alpha.-hydroxyvitamin D.sub.2, 1.alpha.,25-dihydroxyvitamin D.sub.3, 1.alpha.,25-dihydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, 25-hydroxyvitamin D.sub.2, 24-24-difluoro-25-hydroxyvitamin D.sub.3, 24,24-difluoro-1.alpha.,25-dihydroxyvitamin D.sub.3, 24-fluoro-25-hydroxyvitamin D.sub.3, 24-fluoro-1.alpha.,25-dihydroxyvitamin D.sub.3, 2.beta.-fluoro-25-hydroxyvitamin D.sub.3, 2.beta.-fluoro-1.alpha.-hydroxyvitamin D.sub.3, 2.beta.-fluoro-1.alpha.,25-dihydroxyvitamin D.sub.3, 26,26,26,27,27,27-hexafluoro-25- hydroxyvitamin D.sub.3, 26,26,26,27,27,27-hexafluoro-1.alpha.,25-dihydroxyvitamin D.sub.3, 24,25-dihydroxyvitamin D.sub.3, 1.alpha.,24,25-trihydroxyvitamin D.sub.3, 25,26-dihydroxyvitamin D.sub.3, 1.alpha.,25,26-trihyroxyvitamin D.sub.3. 12. The method of claim 10 wherein the administration is the pulse regimen comprising initially administering a hormone or vitamin D compound characterized by its ability to mobilize bone in vivo for a time sufficient to induce new bone resorption cavities, then discontinuing such administration and commencing the administration of 24-epi-1.alpha.,25-dihydroxyvitamin D.sub.2 until net bone formation has been realized. 13. The method of claim 11 wherein the administration is the pulse regimen. 14. The method of claim 13 wherein the vitamin D compound is 1.alpha.,25-dihydroxyvitamin D.sub.3 or 1.alpha.,25-dihydroxyvitamin D.sub.2. 15. The method of claim 13 wherein the hormone is parathyroid hormone. 16. A pharmaceutical composition comprising 1.alpha.,25-dihydroxy-24-epi vitamin D.sub.2 and a pharmaceutically acceptable excipient. 17. A pharmaceutical composition comprising 1 alpha,25-dihydroxy-24-epi-vitamin D.sub.2 and at least one bone mobilization inducing compound selected from the group consisting of the bone-mobilization inducing compounds set forth in claim 12. 18. The pharmaceutical composition of claim 17 wherein the bone mobilization-inducing compound is a vitamin D derivative selected from the group consisting of 25-hydroxyvitamin D.sub.3, 25-hydroxyvitamin D.sub.2, 1.alpha.-hydroxyvitamin D.sub.3, 1.alpha.-hydroxyvitamin D.sub.2, 1.alpha.,25-dihydroxyvitamin D.sub.3, 1.alpha.,25-dihydroxyvitamin D.sub.2, 24,24-difluoro-25-hydroxyvitamin D.sub.3, 24,24-difluoro-1.alpha.,25-dihydroxyvitamin D.sub.3, 24-fluoro-25-hydroxyvitamin D.sub.3, 24-fluoro-1.alpha.,25-dihydroxyvitamin D.sub.3, 26,26,26,27,27,27-hexafluoro-1.alpha.,25-dihydroxyvitamin D.sub.3, 26,26,26,27,27,27-hexafluoro-25-hydroxyvitamin D.sub.3, 2.beta.-fluoro-1.alpha.-hydroxyvitamin D.sub.3, 2.beta.-fluoro-25-hydroxyvitamin D.sub.3, 24,25-dihydroxyvitamin d.sub.3, 1.alpha.,24,25-trihydroxyvitamin D.sub.3, 25,26-dihydroxyvitamin D.sub.3, 1.alpha.,25,26-trihydroxyvitamin D.sub.3.

Details for Patent 4,588,716

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2004-05-04