Claims for Patent: 6,864,228

Summary for Patent: 6,864,228

Title:	Use of bisphosphonates for the treatment of osteogenesis imperfecta
Abstract:	This procedure consists in the first stage, of the administration of enough quantity of bisphosphonate preparation during the necessary period of time to acquire a degree of volumetric mineral density of the cortical tissue of application, within the normal range (average IDS). Then the administration of the bisphosphonate preparation is interruption in order to enable the development of the sectional momentum of inertia. The length of the second stage can be determined by means of a tomography. That is to say, that the periods of administration or non-administration of the mineralizing agent are defined or controlled by precise osteologic variables and therefore are not fixed. If during the second stage the cortical mineral density drops by 6-10% of the maximum value previously obtained, administration of bisphosphonate preparation should be resumed until the corresponding maximum adjusted value is reached again. The proposed procedure of a period with bisphosphonate followed by another period without the bisphosphonate agent improves fracture resistance, provided that the length of both periods is controlled by defined osteologic variables.
Inventor(s):	Roldan; Emilio J. A. (Buenos Aires, AR), Perez Lloret; Anibal (Buenos Aires, AR)
Assignee:	Gador, S.A. (AR)
Application Number:	09/570,275
Patent Claims:	1. A two-stage method for treating osteogenesis imperfecta, comprising: administering to a patient in need thereof a bisphosphonate in a first stage of treatment in order to obtain a predetermine bone volumetric mineral density; performing a bone volumetric mineral density test on said patient; and interrupting administration of the bisphophonate in a second stage of treatment in order to allow for architectonic expansion of the bone, wherein the predetermined bone volumetric mineral density is within the average range of the bone volumetric mineral density of a person.+-.1 SD, said person of the same age as the patient under treatment, wherein the second stage ends when the bone volumetric mineral density falls below the average range of the bone volumetric mineral density of the person or below 10% of the bone volumetric mineral density material obtained at the end of the first stage. 2. The method of claim 1, further comprising determining the duration of the second stage by the development of the sectional momentum of inertia using radiologic means. 3. The method of claim 1, further comprising determining the duration of the second stage bone stability to torsion or flexion using tomography. 4. The method of claim 1, wherein the sectional momentum, of inertia of the person suffering from osteogenesis imperfecta to be treated matches the values of a person of the same age not suffering from Osteogenesis imperfecta. 5. The method of claim 1, further comprising determining at least one of the architectonic expansion of the bone, the bone stability to tension or flexion and bone volumetric mineral density by a method selected from the group comprising tomography and radiologic means. 6. The method of claim 1, further comprising adding a stage comprising administration of the bisphosphonates. 7. The method of claim 6, further comprising adding another stage comprising non-administration of the bisphosphonate. 8. The method of claim 7, further comprising adding at least one further stage, wherein the further stage comprises a first stage comprising administration of the bisphosphonate and a second stage comprising non-administration of the bishophonates. 9. The method of claim 1, further comprising selecting the bisphosphonate from the group consisting of pamidronate, olpadronate, amino-pamidronate, amino-olpadronate (IG 9402), amino-alendronate, amino-etidronate, alendronate, neridronate, ibandronate, risedronate, tiludronate, etidronate, clodronate, incadronate, zolendronate and mixtures of them. 10. The method of claim 9, wherein the bisphosphonate is pamidronate or olpadronate or a mixture of them. 11. The method of claim 1, wherein the bisphosphonate or mixture of bisphosphonate is a bisphosphonate preparation further comprising at least one compound selected from the group consisting of a pharmaceutically acceptable calcium salts, a pharmaceutically acceptable flour salts, vitamin D, Parathyroid hormone PTH, and fractions of PTH. 12. The method of claim 1, wherein the bisphosphonate is present in gastro-resistant formulations for oral administration. 13. The method of claim 1, further comprising administrating bisphosphonate at 25 to 300 mg daily doses. 14. The method of claim 1, wherein the bisphosphonate or the bisphosphonate comprising preparation is an injectable preparation, wherein the doses of bisphosphonate are about 5-60 mg for each administration at one-week to six-months intervals. 15. The method of claim 1, wherein the bisphosphonate is comprised in a preparation with the preparation being selected from the group consisting of tablets, capsules, solid forms, liquid soluble or suspension forms, gels and soft capsules. 16.A two-stage method for treating osteogenesis imperfecta comprising: administering to a patient in need thereof a bisphosphonate in a first stage of treatment in order to obtain a predetermine bone volumetric mineral density; performing a bone volumetric mineral density test on said patient; and interrupting administration of the bisphophonate in a second stage of treatment in order to allow for architectonic expansion of the bone, wherein the predetermined bone volumetric mineral density is within the average range of the bone volumetric mineral density of a person.+-.1 SD, said person of the same age as the patient under treatment, wherein the second stage ends when the bone volumetric mineral density falls below the average range of the bone volumetric mineral density of the person or below 10% of the bone volumetric mineral density material obtained at the end of the first stage, wherein the bone volumetric mineral density is determined by measurement of sectional momentum of inertia.

Details for Patent 6,864,228

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-03-29