# US 7,612,034 B2 · Treatment of subnormal bone mineral density

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- Number: US 7,612,034 B2
- Document ID: US7612034B2
- Status: Granted
- Kind: B2
- Application number: 11/024,557
- Filed: 2004-12-28
- Published: 2005-05-26
- Granted: 2009-11-03
- Earliest claimed: 1999-11-12
- Assignees: Genelabs Technologies, Inc.
- Inventors: Kenneth E. Schwartz
- Web page: https://patentgrep.com/patent/US7612034B2

## CPC

- A61K 38/22: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35)
- A61K 31/5685: having an oxo group in position 17, e.g. androsterone
- A61K 38/225: {Calcitonin gene related peptide}
- A61K 38/23: Calcitonins
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A method of treating an individual to increase the individual's bone mineral density (BMD) is disclosed. The method includes co-administering a calcitonin-like agent and a DHEA-like agent. Also disclosed are methods for potentiating the effect of treatment with a calcitonin-like agent on BMD and for increasing BMD in an individual being treated with DHEA, e.g., for treatment of systemic lupus erythematosus (SLE).

## Claims

### Claim 1

A pharmaceutical formulation for inhibiting bone loss in an individual comprising an effective amount DHEA (prasterone) and an effective amount of a calcitonin-like agent; wherein:
at least about 85% of the DHEA is present as form I polymorph, form II polymorph, or a combination thereof; and
the calcitonin-like agent is selected from the group consisting of salmon or mammalian calcitonin, calcitonin gene-related peptide (CGRP), and native amylin.

### Claim 2 (depends on 1)

The pharmaceutical formulation of claim 1, wherein at least about 95% of the DHEA is present as the form I polymorph, the form II polymorph, or a combination thereof.

### Claim 3 (depends on 2)

The pharmaceutical formulation of claim 2, wherein at least about 95% of the DHEA is present as the form I polymorph.

### Claim 4 (depends on 2)

The pharmaceutical formulation of claim 2, wherein at least about 95% of the DHEA is present as the form II polymorph.

### Claim 5 (depends on 1)

The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is suitable for oral administration.

### Claim 6 (depends on 5)

The pharmaceutical formulation of claim 5, wherein said effective amount of (DHEA) is about 50 mg per day.

### Claim 7 (depends on 5)

The pharmaceutical formulation of claim 5, wherein said effective amount of (DHEA) is about 100 mg per day.

### Claim 8 (depends on 5)

The pharmaceutical formulation of claim 5, wherein said effective amount of (DHEA) agent is about 200 mg per day.

### Claim 9 (depends on 1)

The pharmaceutical formulation of claim 1, wherein the calcitonin-like agent is salmon or mammalian calcitonin.

### Claim 10 (depends on 1)

The pharmaceutical formulation of claim 1, wherein the calcitonin-like agent is calcitonin gene-related peptide (CGRP).

### Claim 11 (depends on 1)

The pharmaceutical formulation of claim 1, wherein the calcitonin-like agent is native amylin.

### Claim 12 (depends on 1)

The pharmaceutical formulation of claim 1, wherein DHEA potentiates any inhibition of bone loss achievable by administration of that amount of the calcitonin-like agent alone.

### Claim 13

A pharmaceutical formulation for inhibiting bone loss in an individual consisting of an effective amount of a dehydroepiandrosterone (DHEA)-like agent, an effective amount of a calcitonin-like agent, and a physiologically acceptable carrier, excipient, diluent, or buffer; wherein:
the DHEA-like agent is selected from the group consisting of DHEA (prasterone), 7-alpha-hydroxy-DHEA, 5-androstene-3-beta, 17-beta-diol, and 4 androstene diol; and
the calcitonin-like agent is selected from the group consisting of salmon or mammalian calcitonin, calcitonin gene-related peptide (CGRP), and native amylin.

### Claim 14 (depends on 13)

The pharmaceutical formulation of claim 13, wherein said pharmaceutical formulation is suitable for oral administration.

### Claim 15 (depends on 14)

The pharmaceutical formulation of claim 14, wherein said effective amount of said dehydroepiandrosterone (DHEA)-like agent is about 50 mg per day.

### Claim 16 (depends on 14)

The pharmaceutical formulation of claim 14, wherein said effective amount of said dehydroepiandrosterone (DHEA)-like agent is about 100 mg per day.

### Claim 17 (depends on 14)

The pharmaceutical formulation of claim 14, wherein said effective amount of said dehydroepiandrosterone (DHEA)-like agent is about 200 mg per day.

### Claim 18 (depends on 13)

The pharmaceutical formulation of claim 13, wherein the DHEA-like agent is DHEA.

### Claim 19 (depends on 13)

The pharmaceutical formulation of claim 13, wherein the DHEA-like agent is 7-alpha-hydroxy-DHEA.

### Claim 20 (depends on 13)

The pharmaceutical formulation of claim 13, wherein the DHEA-like agent is 5-androstene-3-beta, 17-beta-diol.

### Claim 21 (depends on 13)

The pharmaceutical formulation of claim 13, wherein the DHEA-like agent is 4 androstene diol.

### Claim 22 (depends on 13)

The pharmaceutical formulation of claim 13, wherein the calcitonin-like agent is salmon or mammalian calcitonin.

### Claim 23 (depends on 13)

The pharmaceutical formulation of claim 13, wherein the calcitonin-like agent is calcitonin gene-related peptide (CGRP).

### Claim 24 (depends on 13)

The pharmaceutical formulation of claim 13, wherein the calcitonin-like agent is native amylin.

### Claim 25 (depends on 13)

The pharmaceutical formulation of claim 13, wherein the DHEA-like agent potentiates any inhibition of bone loss achievable by administration of that amount of the calcitonin-like agent alone.