Kit for use in the treatment of osteoporosis

• US 4,812,311 A
• Filed: 09/12/1986
• Issued: 03/14/1989
• Est. Priority Date: 12/21/1984
• Status: Expired due to Term

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Uchtman, Vernon A.
• Primary Examiner(s): Schenkman, Leonard
• Application Number:
  US06/906,859
• Time in Patent Office: 914 Days
• Field of Search: 424/128, 424/112, 514/167, 514/141
• US Class Current: 514/141
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61K 31/66 Phosphorus compounds
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof

Abstract

A kit for use in the treatment of osteoporosis is disclosed. The kit comprises a bone cell activating compound, a bone resorption inhibiting polyphosphonate, and a nutrient supplement or placebo, for sequential administration.

Claims

1. A kit for use in a regimen for treatment or prevention of osteoporosis, said regimen comprising sequential administration of a bone cell activating compound, a bone resorption inhibition polyphosphate, and a placebo, or a nutrient supplement, said kit containing the following components:

(a) from 1 to about 5 daily doses of a bone cell activating amount each of a bone cell activating compound;

(b) from about 10 to about 20 daily doses of from about 0.25 mgP/kg/day to about 3.3 mgP/kg/day of ethane-1-hydroxy-1,1-diphosphonic acid, or a pharmaceutically-acceptable salt or ester thereof;

(c) from about 30 to about 100 daily doses of a placebo or a nutrient supplement;

and a means for having the components arranged in a way as to facilitate compliance with the regimen.

2. The kit of claim 1 wherein the daily doses of the ethane-1-hydroxy-1,1-diphosphonic acid, or a pharmaceutically-acceptable salt or ester thereof, are from about 0.25 mgP/kg/day to about 2.5 mgP/kg/day.

3. The kit of claim 1 wherein said means is a card having arranged thereupon said components in the order of their intended use.

4. The kit of claim 2 wherein said means is a card having arranged thereupon said components in the order of their intended use.

5. The kit of claim 1 wherein said means is a dispenser designed to dispense said daily doses, one at a time, in the order of their intended use.

6. The kit of claim 2 wherein said means is a dispenser designed to dispense said daily doses, one at a time, in the order of their intended use.

7. The kit of claim 2 wherein the bone cell activating compound is an inorganic phosphate and each daily dose is from about 250 mg P to about 3.6 g P.

8. The kit of claim 7 wherein the bone cell activating compound is an inorganic phosphate and each daily dose is from about 2 g P to about 3 g P.

9. The kit of claim 2 wherein the bone cell activating compound is 1,25-dihydroxy vitamin D₃ and each daily dose is from about 0.1 microgram to about 2 micrograms.

10. The kit of claim 2 wherein the bone cell activating compound is 25-hydroxy vitamin D₃ and each daily dose is from about 10 micrograms to about 200 micrograms.

11. The kit of claim 2 wherein the bone cell activating compound is an inorganic fluoride and each daily dose is from about 10 mg F to about 100 mg F.

12. The kit of claim 2 wherein the bone cell activating compound is thyroxine and each daily dose is from about 1 mg to about 25 mg.

13. The kit of claim 2 wherein the bone cell activating compound is triiodothyroxine and each daily dose is from about 10 micrograms to about 150 micrograms.

14. The kit of claim 2 wherein the bone cell activating compound is prostaglandin PGE₂ and each daily dose is from about 7.5 mg to about 2 g.

15. The kit of claim 1 wherein the daily dose of ethane-1-hydroxy-1,1-diphosphonic acid, or a pharmaceutically-acceptable salt or ester thereof, is from about 15 mg P to about 200 mg P.

16. The kit of claim 15 wherein the daily dose of ethane-1-hydroxy-1,1-diphosphonic acid, or a pharmaceutically-acceptable salt or ester thereof, is from about 15 mg P to about 150 mg P.

17. A kit for use in a regimen for treatment or prevention of osteoporosis, said regimen comprising, sequential administration of inorganic phosphate, ethane-1-hydroxy-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof, and a mixture of vitamin D and calcium, said kit containing the following components:

(a) a card having arranged thereupon 3 daily doses of inorganic phosphate, each daily dose containing about 2000 mg P;

(b) a card having arranged thereupon 14 daily doses of about 100 mg P each of ethane-1-hydroxy-1,1-diphosphonic acid, or a pharmaceutically acceptable salt or ester thereof;

(c) a plurality of cards containing about 73 daily doses, each dose containing about 500 mg calcium.