Method for treating bone fracture with anti-sclerostin antibodies

A sclerostin and antibody technology, applied in the field of sclerostin inhibitors to enhance fracture healing, 11/411,003, can solve problems such as limiting productivity, reducing the possibility of earning money and the ability to take care of family members, and difficulty in estimating indirect costs

Inactive Publication Date: 2010-11-24
AMGEN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Indirect costs are even more difficult to estimate
Fractures often result in restricted productivity, which in some cases reduces earning potential and ability to care for family members

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] This example illustrates the ability of sclerostin inhibitors, namely anti-sclerostin monoclonal antibodies (Scl-mAb) to enhance bone healing.

[0081] Externally fixed femoral osteotomy model (further described in Murnaghan et al., Journal of Orthopaedic Research, 23(3):625-631 (2005) and Connolly et al., Journal of Orthopaedic Research, 21:843-849 (2003) ) Used to examine the effect of anti-sclerostin antibody treatment on fracture healing in mice. 80 male CD 1 mice (9 weeks old) underwent osteotomy on the right femur. Under general anesthesia and aseptic conditions, a lateral incision was made on the shaved skin and fascia lata from the left knee of the mouse to the greater trochanter (greater trochanter). Open the plane between the vastis and hamstrings by blunt peeling to expose the femur. Drill 4 proximal small holes, and perform a middiaphyseal osteotomy of the femur. The use of a custom-made jig and a hand saw ensures the precise centering of the lateral osteoto...

Embodiment 2

[0086] This example illustrates the use of the method of the present invention to enhance bone healing in vivo.

[0087] Closed femoral fracture model (further described in Bonnarens et al., J Orthop. Res., 2:97-101 (1984) and Li et al., J Bone Miner. Res., 18(11): 2033-42 (2003)) Used to examine the effect of Scl-mAb (sclerostin binding agent) treatment on fracture healing in rats. A standard closed midshaft fracture was produced in the femur of a male SD rat (9 weeks old). In short, after anesthesia, a needle (1.8 mm in diameter) is introduced into the medullary canal of the right femur, and a device composed of a blunt truncator driven by a drip weight is used to produce a middle diaphysis fracture. After surgery, use saline vehicle (1μl / gram body weight) twice a week for 2 weeks (group 1) or 4 weeks (group 2); Scl-mAb (25mg / kg) twice a week for 2 Week (group 3); Scl-mAb (25mg / kg) twice a week for 2 weeks (group 4); or Scl-mAb (25mg / kg) twice a week for 4 weeks (group 5) sub...

Embodiment 3

[0092] This example illustrates the use of sclerostin inhibitors, ie, anti-sclerostin antibodies, to enhance bone healing in primates.

[0093] Due to the similarity in the time course of anatomy, cortical bone reconstruction and healing, non-human primates provide an excellent model of human fracture healing. Stable fibula osteotomy model (further described in Seeherman et al., J Bone Joint Surg. Am., 86: 1961-1972 (2004); Seeherman et al., J Bone Joint Surg. Am., 88: 144-160 ( 2006), and Radomsky et al., Journal of Orthopaedic Research, 17:607-614 (1999) have been used in cynomolgus monkeys and baboons to study the effect of therapeutic agents on fracture healing. The fibula osteotomy model is minimally traumatic, heals consistently in a known schedule, and can be performed bilaterally (on both fibulae). This model was used to examine the effect of Scl-mAb on fracture healing in young male cynomolgus monkeys over a period of 10 weeks.

[0094] 44 male cynomolgus monkeys (4 to 5...

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Abstract

The invention provides a method of enhancing bone fracture healing involving administering a sclerostin inhibitor. In one aspect, the invention includes use of a therapeutically effective amount of sclerostin binding agent to treat a bone fracture, wherein one or more administrations of the sclerostin binding agent are administered over a treatment period lasting at least two weeks and beginning within two weeks of the fracture.

Description

[0001] The present invention generally relates to methods for enhancing fracture healing using sclerostin inhibitors. [0002] Cross-reference related applications and merge by reference [0003] This application claims the priority of U.S. Provisional Patent Application 61 / 013,917 filed on December 14, 2007. In addition, the following applications are incorporated herein by reference in their entireties: US provisional patent application 60 / 973,024 filed on September 17, 2007, US patent application 11 / 410,540 filed on April 25, 2006, which requires April 2006 U.S. Provisional Patent Application 60 / 792,645 filed on the 17th, U.S. Provisional Patent Application 60 / 782,244 filed on March 13, 2006, U.S. Provisional Patent Application 60 / 776,847 filed on February 24, 2006, and May 3, 2005 The priority of the U.S. Provisional Application 60 / 677,583 filed; and the U.S. Patent Application 11 / 411,003 filed on April 25, 2006, which requires the U.S. Provisional Patent Application 60 / 792,645...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P19/00C07K16/22
CPCA61K2039/545C07K16/22A61K2039/505C07K2317/76A61P19/00A61P19/08
Inventor 柯华珠
Owner AMGEN INC
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