Methods for treating postmenopausal women using ultra-low doses of estrogen

a technology of estrogen and ultra-low dose, applied in the field of methods for treating postmenopausal women using ultra-low doses of estrogen, can solve the problems of inconclusive studies of the relationship between osteoporotic bone fractures and osteoporotic bone fractures, a marked increase in bone loss and subsequent fractures, etc., and achieve the effect of reducing the risk of osteoporotic bone fractures

Inactive Publication Date: 2008-05-22
RGT UNIV OF CALIFORNIA +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0005]As a second aspect, the present invention provides a method for reducing the risk of osteoporotic bone fractures in a subject afflicted with or susceptible to postmenopausal osteoporosis. The method comprises administering to the subject, an amount of estrogen which is effective to produce a serum estradiol level of between about 5 pg / ml and about 15 pg / ml.
[0006]As a third aspect, the present invention provides a kit for use by a consumer afflicted with or susceptible to physical conditions resulting from postmenopausal estrogen decline. The kit comprises a) a transdermal patch capable of transdermally administering less than about 20 μg of estrogen per day; and b) instructions describing a method of using the transdermal patch to reduce the risk of bone fracture in the consumer.
[0008]As a fifth aspect, the present invention provides another method for reducing the risk of osteoporotic bone fractures in a subject afflicted with or susceptible to osteoporosis. The method includes administering less than about 20 μg of estrogen per day in the absence of exogenous progestin.

Problems solved by technology

Endogenous estrogens fall dramatically after natural or surgical menopause, and this decline results in a marked increase in bone loss and subsequent fractures.
However, the importance of endogenous estrogens in older women is less certain.
However, estradiol is a more potent estrogen that estrone, and studies of its relationship to fractures have been inconclusive.
However, studies have indicated that hormone replacement therapy may be linked to increased risk of breast and endometrial cancers, as well as blood clotting and bleeding from the uterus.

Method used

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  • Methods for treating postmenopausal women using ultra-low doses of estrogen
  • Methods for treating postmenopausal women using ultra-low doses of estrogen
  • Methods for treating postmenopausal women using ultra-low doses of estrogen

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0040]The following example and data demonstrate the correlation between serum estradiol level and risk of osteoporotic bone fracture and also demonstrate the efficacy of using an ultra-low dose of exogenous estrogen to reduce the risk of osteoporotic bone fracture and for the treatment of postmenopausal symptoms.

[0041]1. Experimental Population

[0042]The Study of Osteoporotic Fractures is a prospective study of a cohort of 9,704 women who were recruited from population-based listings in four communities in the United States Baltimore, Minneapolis, Pittsburgh and Portland. See, Cummings et al., N. Engl. J. Med. 332:767-773 (1995). Women age 65 or older were invited by mail to participate in the study. The experimental population excluded black women, because of their low risk of hip fractures, and women who had bilateral hip replacements or who needed the help of another person to walk. Participants were asked about current or recent use of estrogen, calcium supplements and multivita...

example 2

[0074]This example demonstrates a comparison of the effects of administering differing amounts of estrogen using a 7-day estrogen transdermal therapeutic system, on the prevention of bone loss in postmenopausal women.

[0075]1. Methods

[0076]Healthy, hysterectomized women, 45-65 years old, 1-5 years after menopause with a baseline bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DEXA) at L2-L4 within 2.5 S.D. of the mean for normal women less than 45 years old were eligible. Subjects were randomized to 1 of 4 doses of estradiol TTS (patches of 6.5, 12.5, 15, and 25 cm2 delivering 0.025, 0.05, 0.06, and 0.1 mg / day estradiol, respectively) or placebo. One patch per week was worn on the abdomen for the duration of the 2-year trial. BMD at L2-L4, the femoral neck and forearm, serum osteocalcin (OST) and urinary deoxypyridinoline crosslinks / creatinine ration (DPD) were measured every 6 months. The results after 18 months treatment are presented.

[0077]2. Results

[0078]...

example 3

[0081]The following example and data demonstrate the correlation between serum estradiol level and loss of bone mineral density. The example also demonstrates the efficacy of using an ultra-low dose of exogenous estrogen to reduce loss of bone mineral density.

[0082]1. Experimental Population

[0083]Subjects were participants in the Study of Osteoporotic Fractures (SOF), the details of which have been described in Example 1. This study is based upon a randomly sampled subcohort of 261 SOF participants who had blood drawn and had technically adequate calcaneal BMD measured at both the baseline examination and at follow-up in 1993-94. Among these, 241 women had technically adequate hip bone mineral density measurements both at the year 2 examination in 1990 and at follow-up in 1993-94. Final results are based upon subcohorts of 231 and 218 women with complete calcaneal and hip BMD scan pairs, respectively, who did not report current use of estrogen replacement therapy during the base lin...

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Abstract

The present invention provides methods for treating physical conditions resulting from postmenopausal estrogen decline in a postmenopausal subject, and in particular methods for reducing the risk of osteoporotic bone fractures in a postmenopausal subject. The present invention also provides a kit useful for carrying out the methods of the present invention.

Description

BACKGROUND OF THE INVENTION[0001]Endogenous estrogens fall dramatically after natural or surgical menopause, and this decline results in a marked increase in bone loss and subsequent fractures. Endogenous estrogens are clearly important for the maintenance of skeletal health in younger women. However, the importance of endogenous estrogens in older women is less certain.[0002]It has been previously shown that endogenous estrone levels in women over age 65 were not associated with subsequent hip or vertebral fractures. S. R. Cummings, et al., J. Bone Min. Res. 10 (Suppl I):S174 (1995). However, estradiol is a more potent estrogen that estrone, and studies of its relationship to fractures have been inconclusive. Serum estradiol levels in premenopausal women average over 100 pg / ml. Serum estradiol levels in postmenopausal women not being treated with hormone replacement therapy fall below 20 pg / ml and as many as 30-50 percent of postmenopausal women have serum estradiol levels which ar...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/565A61P5/30A61F13/00A61K9/70A61K31/56
CPCA61F2013/00906A61K31/565A61K31/56A61K9/7023A61P5/30
Inventor CUMMINGS, STEVEN R.ETTINGER, BRUCEELLMAN, HERMAN
Owner RGT UNIV OF CALIFORNIA
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