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

A technology of estrogen and dosage, which is applied in the direction of pharmaceutical formulations, nervous system diseases, medical preparations containing active ingredients, etc., and can solve problems such as no results

Inactive Publication Date: 2001-01-10
RGT UNIV OF CALIFORNIA +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, estradiol is a more potent estrogen than estrone, and

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The following examples and data demonstrate the association between serum estradiol levels and osteoporotic fractures, and also demonstrate the effectiveness of using ultra-low doses of exogenous estrogen to reduce the risk of osteoporotic fractures and treat postmenopausal symptoms. effect. 1. Test population

[0042] The Osteoporotic Bone Study was a prospective study of a cohort of 9704 women recruited from the full population lists of 4 US communities: Baltimore, Minneapolis, Pittsburgh, and Portland. See Cummings et al., N. Engl. J. Med. 332:767-773 (1995). Women aged 65 or older participated in the study by petition. The trial population included black women because of their low risk of hip fracture, as well as women with bilateral hip reductions or women who needed assistance with walking. Participants answered questions about current or recent use of estrogen, calcium supplements, and multivitamins containing vitamin D. 2. clinical measurement

[0043...

Embodiment 2

[0088] This example demonstrates the comparison of the effect of different doses of estrogen administered on the prevention of bone loss in postmenopausal women using a 7-day transdermal estrogen therapy system. 1. method

[0089] Healthy, hysterectomized women aged 45-65 years and 1-5 years postmenopausal when their baseline bone mineral density (BMD) at L2-L4 by dual-energy X-ray absorptiometry (DEXA) is at 45 years Women within 2.5SD of the mean for normal women were eligible for inclusion. Test subjects were randomized to receive one of four doses of estradiol TTS (6.5, 12.5, 15 and 25 cm 2 The patches released 0.025, 0.05, 0.06 and 0.1 mg / day estradiol, respectively) or placebo. It was pasted on the abdomen every Monday, and the experiment lasted for 2 years. BMD, serum osteocalcin (OST) and uterine deoxypyridinoline cross-linked product / creatinine (DPD) were measured at L2-L4, femoral neck and forearm every 6 months. Results after 18 months of treatment. 2. result...

Embodiment 3

[0093] The following examples and data are used to demonstrate the relationship between serum estradiol levels and bone mineral density loss. These examples also demonstrate the efficacy of reducing bone mineral loss using ultra-low doses of exogenous estrogen. 1. Test population

[0094] The test subjects were participants in the Osteoporotic Fracture (SOF) study, details of which are described in Example 1. The trial was based on a randomly sampled subpopulation of 261 SOF participants who were bled and had technically sufficient calcaneal BMD to be detected at baseline and follow-up in 1993-94. Of these, 241 women had technically adequate hip bone mineral density measurements in the 2 trials in 1990 and in the follow-up trial in 1993-94. The final results were based on subpopulations of 231 and 218 women who had a pair of calcaneal and hip BMD scans, respectively, who reported not taking estrogen-reconstitution therapy at the baseline visit. The sample size for individu...

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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 estrogen levels decrease dramatically after natural or surgical menopause, and this attenuation leads to a marked increase in bone loss and secondary fractures. Clearly, endogenous estrogen plays an important role in maintaining bone health in young women. However, endogenous estrogens are less important in older women. [0002] So far it has been found that endogenous estrogen levels in women around the age of 65 are not associated with secondary 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 than estrone, and studies on its relationship with fractures have been inconclusive. Serum estradiol levels in premenopausal women average above 100 pg / ml. Serum estradiol levels are reduced to 20 pg / ml in postmenopausal women not treated with hormone restoration therapy, and as many as 30-50% of postmenopausal women have serum estradiol levels ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/565A61K31/566A61P1/08A61P15/00A61P15/12A61P19/10A61P25/06A61P25/24
CPCA61K9/7023Y10S514/947A61K31/566A61K31/565A61P1/08A61P15/00A61P15/12A61P19/10A61P25/06A61P25/24A61P5/00A61P5/24A61P5/28A61P5/30
Inventor 史蒂文·卡明斯赫尔曼·埃尔曼布鲁斯·埃廷格
Owner RGT UNIV OF CALIFORNIA
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