Treatment of bone disorders with skeletal anabolic drugs

• US 7,384,912 B2
• Filed: 08/31/2005
• Issued: 06/10/2008
• Est. Priority Date: 01/10/2002
• Status: Expired due to Fees

• Current Assignee: Osteotrophin, LLC
• Original Assignee: Osteotrophin, LLC
• Inventors: Stewart, Andrew F.
• Primary Examiner(s): Gupta; Anish
• Application Number:
  US11/216,511
• Publication Number:
  US 20060025342A1
• Time in Patent Office: 1,014 Days
• Field of Search: None
• US Class Current: 514/11.8
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/29 Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Disclosed herein are methods for the prevention and treatment of a variety of mammalian conditions manifested by loss of bone mass, including osteoporosis. The present invention provides methods of using PTHrP, or analogs thereof, for the treatment of metabolic bone disorders that are both effective and have an increased safety.

Claims

1. A method of increasing bone mass in a human patient in need thereof, said method comprising administering intermittently to said patient PTHrP at a dosage of at least 500 μ

g/day for a period of at least one month, wherein the bone mass density of said patient increases at a rate of at least 1% per month.

2. The method of claim 1, wherein the bone mass density of said patient increases at a rate of at least 1.5% per month.

3. The method of claim 1, wherein said human patient is afflicted with, or at risk of, primary or secondary osteoporosis.

4. The method of claim 1, wherein said human patient is afflicted with, or at risk of, a metabolic bone disorder selected from the group consisting of:

osteomalacia, renal osteodystrophy, and other types of skeletal disorders with associated bone loss.

5. The method of claim 1, wherein PTHrP is administered subcutaneously.

6. A method of treating a human patient afflicted with osteoporosis, said method comprising administering intermittently PTHrP to said patient at a dosage at least about 500 μ

g/day for a period of 1-36 months, wherein the bone mass density of said patient increases at a rate of at least 1% per month.

7. The method of claim 6, wherein the bone mass density of said patient increases at a rate of at least 1.5% per month.

8. The method of claim 6, wherein said PTHrP is administered subcutaneously.

9. The method of claim 6, wherein said PTHrP is administered by the route of administration selected from the group consisting of:

oral, intravenous, intraperitoneal, intramuscular, buccal, rectal, vaginal, intranasal, and aerosol administration.

10. The method of claim 6, wherein said PTHrP is administered until the bone mass density of said patient is restored.