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Treatment of androgen-deprivation induced osteoporosis

A use, the technology of toremifene, applied in the field of treatment of osteoporosis induced by androgen deprivation, can solve the side effects of ADT and other problems

Inactive Publication Date: 2007-10-17
GTX INCORPORATED
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Unfortunately, ADT has serious side effects including hot flashes, gynecomastia, osteoporosis, decreased lean muscle mass, depression and other mood changes, loss of libido, and erectile dysfunction [Stege R (2000 ), Prostate Suppl 10, 38-42]

Method used

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  • Treatment of androgen-deprivation induced osteoporosis
  • Treatment of androgen-deprivation induced osteoporosis
  • Treatment of androgen-deprivation induced osteoporosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0127] Effects of toremifene on osteopenia in male rats

[0128] Introduction and research purpose

[0129] The aims of these studies were to 1) determine the effect of two doses of toremifene (Tor) in preventing bone loss in orchiectomized rats (ORX) by using dual-energy X-ray absorptiometry (DXA) and ash mineral density Carry out bone mineral density analysis to determine; 2) measure the impact of two doses of toremifene (Tor) on bone mechanical strength compared with vehicle treatment ORX rats and sham-operated rats; and evaluate two doses of Torremifene Effects of clomid on bone turnover and histomorphometric indices of bone structure in ORX rats.

[0130] experimental design

[0131] Eight-month-old male Sprague Dawley rats were sham-operated (SHAM) or orchiectomized (ORX). Start treatment immediately after surgery. The treatment groups are shown in Table 1.

[0132] describe

put to death

1

Sham+Carrier

10 animals, at week ...

Embodiment 2

[0186] The effect of toremifene on hot flashes

[0187] Because of the deleterious effects of testosterone on prostate cancer, the gold standard for treating advanced disease is surgical or chemical castration of the patient. However, the resulting low testosterone levels can have serious side effects, including bone loss leading to osteoporosis, hot flashes, and gynecomastia. The adverse effects of hot flashes are mainly quality of life issues. However, hot flashes are often the number one cause of lack of compliance in these men.

[0188] In a phase 2 clinical trial evaluating the effect of toremifene on bone mineral density (BMD) in men with advanced prostate cancer taking a luteinizing hormone-releasing hormone agonist (LHRHa), the frequency of hot flashes was evaluated as Second endpoint. A total of 46 subjects who had received LHRHa for at least 12 months were included in the study. The duration of treatment in this study was 6 months. The hot flash...

Embodiment 3

[0192] Toremifene reverses ADT-induced osteoporosis

[0193] Materials and methods

[0194] Forty-six prostate cancer patients who underwent ADT for at least 12 months with informed consent were randomly assigned to receive placebo or 20 mg, 40 mg, or 60 mg toremifene citrate (Acapodene citrate). TM ), orally administered once a day for a total of 6 months.

[0195] Evaluation included measurement of bone mineral density (BMD), bone turnover markers, and bone resorption markers using dual-energy X-ray absorptiometry (DEXA). BMD was measured by DXA. Levels of bone turnover markers were assessed.

[0196] Based on reports in the literature, the antiandrogen bicalutamide can alter bone metabolism. To avoid possible confounding effects of bicalutamide, patients receiving bicalutamide were excluded from the analysis.

[0197] result

[0198] Toremifene was well tolerated at all doses studied. Giving 60mg / day toremifene made BMD statistically significantly increase af...

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Abstract

The present invention provides methods for reducing the incidence of, inhibiting, suppressing, and treating androgen-deprivation induced osteoporosis, bone fractures and / or loss of bone mineral density (BMD) in men having prostate cancer, comprising administering to a male human subject having prostate cancer a toremifene and / or its analog, derivative, isomer, metabolite. pharmaceutically acceptable salt, pharmaceutical product, hydrate, N-oxide. or any combination thereof. The present invention also provides methods of treating, preventing, suppressing, inhibiting, or reducing the incidence of hot flashes, gynecomastia, and / or hair loss in a subject, comprising same.

Description

field of invention [0001] The present invention provides for reducing the incidence of, inhibiting, suppressing and treating androgen deprivation-induced osteoporosis, fractures and / or decreased bone mineral density (BMD) in an individual. and / or a method of reducing bone mineral density (BMD) comprising administering toremifene and / or its analogs, derivatives, isomers, metabolites, pharmaceutically acceptable salts, pharmaceuticals, hydrates, N- oxides or any combination thereof. The present invention also provides a method for treating, preventing, suppressing, inhibiting hot flashes, gynecomastia and / or alopecia in an individual or reducing the incidence of hot flashes, gynecomastia and / or alopecia in an individual, which comprises administering the above-mentioned substance. Background technique [0002] It is well established that male bone mineral density decreases with age. The reduced amount of bone mineral content and density correlates with reduced bone strength...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/138
CPCA61K31/135A61K9/0014A61K9/0019A61K9/0021A61K9/0024A61K9/0053A61K31/138A61P13/08A61P15/12A61P19/10A61P29/00A61P35/00A61P5/26A61P5/32A61K9/14
Inventor 米切尔·S.·斯坦纳卡伦·A.·韦韦尔卡沙兰·拉格豪
Owner GTX INCORPORATED
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