Claims for Patent: 6,100,301

Summary for Patent: 6,100,301

Title:	Combination therapy to treat osteoporosis-polyphosphonates and estrogen agonists
Abstract:	The present invention provides novel methods of treating or preventing osteoporosis comprising administering to a mammal in need of such treatment an effective amount of a compound of formula I ##STR1## wherein R.sup.1 and R.sup.2 may be the same or different provided that, when R.sup.1 and R.sup.2 are the same, each is a methyl or ethyl group, and, when R.sup.1 and R.sup.2 are different, one of them is a methyl or ethyl group and the other is hydrogen or a benzyl group; or a pharmaceutically acceptable salt thereof; together with a bone resorption inhibiting polyphosphonate, or with parathyroid hormone.
Inventor(s):	Maclean; David B. (Providence, RI), Thompson; David D. (Gales Ferry, CT)
Assignee:	Pfizer Inc (New York, NY)
Application Number:	09/092,100
Patent Claims:	1. A method for inhibiting conditions which present low bone mass comprising administering to a mammal in need of such inhibition an enhanced effective amount of a compound of formula I ##STR4## wherein R.sup.1 and R.sup.2 may be the same or different provided that, when R.sup.1 and R.sup.2 are the same, each is a methyl or ethyl group, and, when R.sup.1 and R.sup.2 are different, one of them is a methyl or ethyl group and the other is a hydrogen or a benzyl group; or a pharmaceutically acceptable salt thereof; together with or in combination with parathyroid hormone. 2. A method according to claim 1 wherein the compound of formula I is a compound wherein R.sup.1 and R.sup.2 each are methyl, or a pharmaceutically acceptable salt thereof. 3. A method according to claim 2 wherein said salt thereof is the citrate salt. 4. A method as recited in claim 1 wherein the condition which presents with low bone mass is osteoporosis. 5. A method as recited in claim 1 wherein the compound of formula I and parathyroid hormone are administered substantially simultaneously. 6. A method as recited in claim 1 wherein parathyroid hormone is administered for a period of from about three months to about three years. 7. A method as recited in claim 6 followed by administration of a compound of formula I for a period of from about three months to about three years without the administration of parathyroid hormone during the period of from about three months to about three years. 8. A method as recited in claim 6 followed by administration of a compound of formula I for a period greater than about three years without the administration of parathyroid hormone during the greater than about three year period. 9. A pharmaceutical composition comprising an enhanced effective amounts of a compound of formula 1 as defined in claim 5 and parathyroid hormone.

Details for Patent 6,100,301

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2016-02-28