Claims for Patent: 4,812,304

Summary for Patent: 4,812,304

Title:	Treatment of osteoporosis
Abstract:	A method for treating or preventing osteoporosis is disclosed. Bone cells are synchronized during a bone cell activating period; bone resorption, which normally follows activation, is inhibited using a polyphosphonate; bone formation is allowed to occur in the rest period during which nutrient supplements may be administered to the patient.
Inventor(s):	Anderson; Colin (Lambeth, CA), Flora; Lawrence (Fairfield, OH)
Assignee:	The Procter & Gamble Company (Cincinnati, OH)
Application Number:	06/906,858
Patent Claims:	1. A method for treating or preventing osteoporosis in humans comprising administering to a subject afflicted with or at risk to osteoporosis a bone cell activating compound and a bone resorption inhibiting polyphosphonate according to a regimen consisting of one or more cycles, whereby each cycle consists of: (a) a bone activating period of from about 1 day to about 5 days during which a bone activating amount of a bone cell activating compound is administered daily to said subject; followed by (b) a bone resorption inhibition period of from about 10 days to about 20 days during which ethane-1-hydroxy-1,1-diphosphonic acid, or a pharmaceutically-acceptable salt or ester thereof, is administered daily to said subject in an amount of from about 0.25 mgP/kg/day to about 3.3 mgP/kg/day; followed by (c) a rest period of from about 70 days to about 180 days during which the subject receives neither a bone cell activating compound nor a bone resorption inhibiting polyphosphonate. 2. The method of claim 1 wherein during the bone resorption inhibition period the ethane-1-hydroxy-1,1-diphosphonic acid, or pharmaceutically-acceptable salt or ester thereof, is administered daily in an amount of from about 0.25 mgP/kg/day to about 2.5 mgP/kg/day. 3. The method of claim 2 wherein the bone cell activating compound is an inorganic phosphate and the bone activating amount is from about 4 mg/kg/day to about 60 mg/kg/day of phosphorous, and not to exceed about 3600 mg P/day. 4. The method of claim 3 wherein the bone cell activating compound is an organic phosphate and the bone activating amount is from about 30 mg/kg/day to about 40 mg/kg/day of phosphorous, and not to exceed about 3600 mg P/day. 5. The method of claim 2 wherein the bone cell activating compound is 1,25-dihydroxy vitamin D.sub.3 and the bone activating amount is from about 0.001 microgram/kg/day to about 0.03 microgram/kg/day. 6. The method of claim 2 wherein the bone cell activating compound is 25-hydroxy vitamin D.sub.3 and the bone activating amount is from about 0.1 microgram/kg/day to about 3 microgram/kg/day. 7. The method of claim 2 wherein the bone cell activating compound is an inorganic fluoride and the bone activating amount is from about 0.1 mg F/kg/day to about 1.0 mg F/kg/day. 8. The method of claim 2 wherein the bone cell activating compound is thyroxine and the bone activating amount is from about 0.01 mg/kg/day to about 0.5 mg/kg/day. 9. The method of claim 2 wherein the bone cell activating compound is triiodothyroxine and the bone activating amount is from about 0.1 microgram/kg/day to about 2.5 microgram/kg/day. 10. The method of claim 2 wherein the bone cell activating compound is prostaglandin PGE.sub.2 and the bone activating amount is from about 0.1 mg/kg/day to about 25 mg/kg/day. 11. The method of claim 2 wherein the bone cell activating compound is parathyroid hormone 1-34 and the bone activating amount is from about 0.1 microgram/kg/day to about 3.0 microgram/kg/day administered subcutaneously. 12. The method of claim 1 wherein during the bone resorption inhibition period the ethane-1-hydroxy-1,1-diphosphonic acid, or pharmaceutically-acceptable salt or ester thereof, is administered daily in an amount from about 0.5 mgP/kg/day to about 2.0 mgP/kg/day. 13. The method of claim 4 wherein during the bone resorption inhibition period of ethane-1-hydroxy-1,1-diphosphonic acid, or pharmaceutically-acceptable salt or ester thereof, is administered daily in an amount from about 0.5 mgP/kg/day to about 2.0 mgP/kg/day. 14. A method for treating or preventing osteoporosis in humans comprising administering to a subject afflicted with or at risk to osteoporosis inorganic phosphate and ethane-1-hydroxy-1,1-diphosphonic acid according to a regimen consisting of one or more cycles, whereby each cycle consists of: (a) a bone activating period of about 3 days during which about 30 mg P/kg, in the form of inorganic phosphate, is administered daily to said subject; followed by (b) a bone resorption inhibition period of about 14 days during which said diphosphonic acid, or a pharmaceutically acceptable salt thereof, is administered daily to said subject at a rate of about 1.24 mgP/kg/day; followed by (c) a rest period of about 80 days during which the subject received calcium at a rate of from about 500 mg/day to about 1000 mg/day and vitamin D at a rate of about 400 units per day.

Details for Patent 4,812,304

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2004-04-30