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Use of compositions comprising an estrogenic component for the treatment and prevention of musculoskeletal pain

A technology of estrogen and progesterone, which is applied in the field of treatment or prevention of muscle and bone pain in mammals, and can solve problems such as side effects

Active Publication Date: 2008-11-12
ESTETRA S P R L
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, as in the case of aromatase inhibitors, administration of these drugs also chronically suppresses endogenous estrogen production and is thus associated with significant side effects

Method used

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  • Use of compositions comprising an estrogenic component for the treatment and prevention of musculoskeletal pain
  • Use of compositions comprising an estrogenic component for the treatment and prevention of musculoskeletal pain
  • Use of compositions comprising an estrogenic component for the treatment and prevention of musculoskeletal pain

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Estetrol was detected in a rat tumor model induced by 7,12-dimethyl-benzanthracene (DMBA) to evaluate the efficacy of the estrogen substances of the present invention on tumors. This model was originally developed by Huggins et al. in 1961 (Nature, 19, 204-207) and has been widely used, and is generally accepted as a model with predictive value for anti-tumor drugs in humans. The growth of DMBA-induced tumors is dependent on endogenously produced estradiol or exogenously administered estrogen and prolactin (Sylvester et al., 1982, Cancer Research, 42, 4943-4947). It has been shown that in the DMBA model, ovariectomy (Hollingsworth et al., 1998, Breast Cancer Research and Treatment, 47, 63-70), androgens (Dauvois et al., 1989, Breast Cancer Treatment, 14, 299-306), other Moxifen (Hollingsworth et al., 1998, Breast Cancer Research and Treatment, 47, 63-70), progesterone (Kelly et al., 1979, Eur.J.Cancer, 15, 1243-1251; Russo et al., 1987, Lab.Invest. 57, 112-137) and GnR...

Embodiment 2

[0088] A randomized, double-blind, placebo-controlled crossover trial to demonstrate that estetrol reduces muscle and bone pain in postmenopausal breast cancer patients receiving estrogen suppression therapy.

[0089] Twenty postmenopausal patients with stage I or II breast cancer were recruited. These patients were adequately treated with surgery, chemotherapy, and / or radiotherapy, showed a history of estrogen receptor-positive tumors, had no contraindications to steroid therapy, had received at least 3 months of anti-estrogens or aromatase inhibitors, and had Musculoskeletal pain symptoms (defined as skeletal pain, pain in the legs, arms, and back) are present. In addition, other diagnoses such as rheumatoid arthritis and / or other bone or joint diseases were excluded during the screening phase.

[0090] The patients participated in a 15-week clinical trial and were randomly divided into the following groups:

[0091] Group 1 (n=10)

[0092] Throughout the trial, patients ...

Embodiment 3

[0100] Using methods as established in Example 4, a randomized, double-blind, placebo-controlled crossover trial was conducted to demonstrate that estetrol reduces muscle and bone pain in premenopausal breast cancer patients receiving estetrol inhibitor therapy.

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Abstract

The present invention relates to a method of treating or preventing musculoskeletal pain in a mammal receiving administration of an estrogen. suppressant selected from the group consisting of aromatase inhibitors, GnRH analogues, cyclo-oxygenase 2 (COX-2) inhibitors, 17beta-hydroxysteroid dehydrogenase type 1 inhibitors, progestogens, anti-estrogens and combinations thereof, said method comprising the administration of an effective amount of an estrogenic component, wherein the estrogenic component is selected from the group consisting of : substances represented by the following formula (I) in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 1-5 carbon atoms; precursors capable of liberating a substance according to the aforementioned formula when used in the present method; and mixtures of one or more of the aforementioned substances and / or precursors.

Description

technical field [0001] The present invention relates to methods of treating or preventing musculoskeletal pain in mammals. More specifically, the present invention relates to the treatment or prevention of muscle and bone pain in mammals receiving administration of estrogen inhibitors selected from the group consisting of aromatase inhibitors, GnRH analogs, cyclooxygenase 2 (COX -2) Inhibitors, type I 17β-hydroxysteroid dehydrogenase inhibitors, progestogens, antiestrogens and combinations thereof. Background technique [0002] Breast cancer is one of the most prevalent cancers. Epidemiological and clinical studies have shown that up to 60% of breast tumors in premenopausal women express estrogen receptors and about 80% of breast tumors in postmenopausal women are estrogen sensitive. This means that estrogen is required for the growth of the above-mentioned breast tumors in premenopausal as well as postmenopausal patients. It is now well known that the in situ generation ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/565A61P19/02A61K45/06
CPCA61K45/06A61K31/565A61P19/00A61P19/02A61K2300/00
Inventor 赫尔曼·扬·蒂杰曼·科尔林格本宁克埃弗特·约翰内斯·本舍滕
Owner ESTETRA S P R L
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