Claims for Patent: 5,861,438

Summary for Patent: 5,861,438

Title:	Combination therapy to prevent bone loss parathyroid hormone and estrogen agonists
Abstract:	The present invention provides novel methods of inhibiting bone loss 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 a hydrogen or a benzyl group; or a pharmaceutically acceptable salt thereof; together with or in combination with parathyroid hormone.
Inventor(s):	MacLean; David B. (Providence, RI), Thompson; David D. (Gales Ferry, CT)
Assignee:	Pfizer Inc. (New York, NY)
Application Number:	08/803,712
Patent Claims:	1. A method for inhibiting conditions which present low bone mass comprising administering to a mammal in need of such inhibition an synergistic 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 halogen or a benzyl group; or a pharmaceutically acceptable salt thereof; together with or in combination with an effective amount of 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 effective amount of a compound of formula I ##STR5## wherein R.sup.1 and R.sup.2 may be the same of 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; and an effective amount of parathyroid hormone. 10. A kit containing a treatment for a condition which presents low bone mass comprising: A therapeutically synergistic effective amount of a compound of formula I ##STR6## wherein R.sup.1 and R.sup.2 may be the same of 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; and a pharmaceutically acceptable carrier in a first unit dosage form; a therapeutically effective amount of parathyroid hormone and a pharmaceutically acceptable carrier in a second unit dosage form; and container means for containing said first and second dosage forms.

Details for Patent 5,861,438

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