Claims for Patent: 5,320,970

Summary for Patent: 5,320,970

Title:	Detection of collagen degradation in vivo
Abstract:	Methods of determining collagen degradation in vivo, by quantitating the concentration of a peptide in a body fluid, the peptide having the following structure: ##STR1## is hydroxylysyl pyridinoline or lysyl pyridinoline, and J is pyroglutamic acid or glutamine and (Leu) are optional leucines, are disclosed. Compositions useful in quantitating collagen peptides to determine the rate of bone resorption are prepared by treating bone with a protease, such as collagenase, and purifying the compositions so as to enrich them with peptides capable of binding to the monoclonal antibody MAb-1H11.
Inventor(s):	Eyre; David R. (Mercer Island, WA)
Assignee:	Washington Research Foundation (Seattle, WA)
Application Number:	07/708,529
Patent Claims:	1. A composition comprising peptides produced by digesting bone collagen with a protease capable of generating peptides that bind to the monoclonal antibody 1H11 , and then purifying the digested bone collagen to enrich the concentration of peptides that contain the epitope recognized by 1H11 by at least 10-fold, wherein the protease is collagenase. 2. A composition according to claim 1 in an aqueous solution. 3. A composition according to claim 2 wherein the concentration of said peptides is about 1 to about 100 picomoles per milliliter of said aqueous solution. 4. A composition according to claim 1, coated on a solid substrate. 5. A composition according to claim 4, wherein said solid substrate is a microtiter assay plate. 6. A composition according to claim 4, wherein the peptides are conjugated to bovine serum albumin to facilitate coating onto said solid substrate. 7. A composition according to claim 1, wherein said peptides are labeled with a detectable marker. 8. A kit for determining the rate of bone resorption, comprising a container of a composition according to claim 2. 9. A kit for determining the rate of bone resorption, comprising a coated microtiter assay plate according to claim 5. 10. A kit for determining the rate of bone resorption, comprising a container of a composition according to claim 7. 11. A method of determining the rate of bone resorption comprising contacting a body fluid with an immunological binding partner to a cross-linked N-telopeptide derived from bone collagen and detecting the amount of bound immunological binding partner, contacting a composition according to claim 1 with said immunological binding partner to standardize the amount of bound immunological binding partner, and comparing said amounts to determine the rate of bone resorption. 12. A method of determining the rate of bone resorption comprising contacting a body fluid with an immunological binding partner to a cross-linked N-telopeptide derived from bone collagen in the presence of a composition according to claim 7 and detecting the amount of said immunological binding partner bound to said composition to determine the rate of bone resorption.

Details for Patent 5,320,970

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2011-06-14