METHOD FOR FOSTERING BONE FORMATION AND PRESERVATION

• US 20080183134A1
• Filed: 03/31/2008
• Published: 07/31/2008
• Est. Priority Date: 05/14/2004
• Status: Abandoned Application

• Current Assignee: Unigene Laboratories Incorporated, Yale University
• Original Assignee: Unigene Laboratories Incorporated, Yale University
• Inventors: Vignery, Agnes, Gilligan, James P., Mehta, Nozer M.
• Application Number:
  US12/059,605
• Publication Number:
  US 20080183134A1
• Time in Patent Office: Days
• US Class Current: 604/131
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61K 38/1833 Hepatocyte growth factor; Scatter factor; Tumor cytotoxic factor II
• CPC Class Codes: A61K 38/1841 Transforming growth factor [TGF]
• CPC Class Codes: A61K 38/1875 Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
• CPC Class Codes: A61K 38/225 Calcitonin gene related peptide
• CPC Class Codes: A61K 38/29 Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
• CPC Class Codes: A61K 38/30 Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2 insulin-like growth factor binding protein A61K38/1754
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: Y10S 435/81 Packaged device or kit

Abstract

A method of inducing bone formation in a subject in need of such inducement comprises the steps of mechanically inducing an increase in osteoblast activity in the subject and elevating blood concentration of at least one bone anabolic agent in the subject. The method steps may be performed in any order, but in sufficient time proximity that the elevated concentration of the anabolic agent and the mechanically induced increase in osteoblast activity overlaps. The method may additionally comprise providing the subject with an elevated blood concentration of at least one antiresorptive agent, wherein the elevated concentration is sufficient to prevent resorption of new bone growth produced due to the osteoblast activity. Use of the method permits targeting of specific bones of the subject for bone production and preservation, faster bone production and earlier discontinuation of bone anabolic pharmaceuticals. Kits adapted for performing the method are provided.

Claims

1. A kit for fostering bone formation in at least one targeted bone of a subject in need of said bone formation, said kit comprising:

(a) at least one container having therein at least one bone anabolic agent; and

(b) a mechanical alteration device for altering contents of a bone marrow cavity in at least one said targeted bone.

2. The kit of claim 1, further comprising an evacuation device for evacuating at least a portion of the contents from said cavity.

3. The kit of claim 1, further comprising at least one container having therein at least one antiresorptive agent.

4. The method of claim 1, wherein the bone anabolic agent is CGRP or PTHrP.

5. The kit of claim 1, wherein said bone anabolic agent is selected from the group consisting of natural parathyroid hormone, a truncate of natural parathyroid hormone, an amidated truncate of natural parathyroid hormone, an amidated natural parathyroid hormone, and combinations thereof.

6. The kit of claim 5, wherein the bone anabolic agent is selected from the group consisting of PTH[1-84] in the free acid form, PTH[1-84]NH₂, PTH[1-34] in the free acid form, PTH[1-30]NH₂, PTH[1-31]NH₂, PTH[1-32]NH₂, PTH[1-33]NH₂, PTH[1-34]NH₂ and combinations thereof.

7. The kit of claim 3, wherein the antiresorptive agent is a calcitonin selected from the group consisting of human calcitonin, salmon calcitonin, eel calcitonin, elkatonin, porcine calcitonin, chicken calcitonin, and combinations thereof.

8. A kit for fostering bone formation in at least one targeted bone in a subject in need of said bone formation, said kit comprising:

(a) at least one container having therein at least one antiresorptive agent; and

(b) a mechanical alteration device for altering contents of a bone marrow cavity in at least one said targeted bone.

9. The kit of claim 8, wherein the antiresorptive agent is a calcitonin selected from the group consisting of human calcitonin, salmon calcitonin, eel calcitonin, elkatonin, porcine calcitonin, chicken calcitonin and combinations thereof.

10. The kit of claim 8, further comprising an evacuation device for evacuating at least a portion of the contents from said cavity.