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Protocol Number:
06-CH-0091
- Title:
The Effects of Endometriosis on Bone Mineral Density
- Number:
06-CH-0091
- Summary:
This study will compare bone mass in women with a history of endometriosis, a disease in which the lining of the uterus grows on nearby tissues, to that of women who have not had endometriosis. Endometriosis may be treated with medication or surgery, or both. Because uterine tissue grows more when estrogen levels are high, medical treatment is designed to lower estrogen. Decreased estrogen, however, is often associated with weak bones and hot flashes. Also, women with endometriosis may have lower bone density as a consequence of their disease. This study will look at bone density in these women, particularly to see if areas other than the lower back may be affected.
Regularly menstruating women between 40 and 50 years old, with or without a history of endometriosis, may be eligible for this study. Candidates are screened by telephone; women with endometriosis are asked to provide documentation of their endometriosis before beginning the study.
Study participants undergo the following tests and procedures:
-Medical history and blood sample collection
-Questionnaires about exercise activity, calcium intake, menstrual cycle history, cigarette use and medication history
-DEXA scan: This test evaluates the strength of the bones in the back, wrist, and hip. The DEXA scanner uses low-energy x-rays to determine bone density. Scans are done of the lower spine, upper thigh, hip, and the entire body. For the test, the subject lies on the scanning table. Each scan takes about 3 minutes, and the entire procedure may take as long as 1 hour.
- Sponsoring Institute:
-
National Institute of Child Health and Human Development (NICHD)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Female
- Referral Letter Required:
No
- Population Exclusion(s):
Male
Children
- Eligibility Criteria:
INCLUSION CRITERIA:
1. Regularly cycling women between the ages of 40 and 50 with surgically documented endometriosis (preferably biopsy proven, but unequivocal operative reports may allow inclusion).
OR
2. Regularly cycling women between the ages of 40 and 50 who are healthy volunteers.
Women will be matched by ethnicity, by BMI within 5 kg/M(2), and by age (at the time of DEXA) in two groups: 40 - 45 years and 45 - 50 years.
EXCLUSION CRITERIA:
Women who are pregnant or lactating or who have abnormalities in the medical history or screening laboratory tests that might contribute to abnormal BMD (e.g. hypercalcemia, renal failure) will not be enrolled
We will not include women who currently or have previously taken medications known to affect bone mineral density (e.g. thyroid hormone suppression, supraphysiologic glucocorticoids, GnRH, dilantin) or those that suggest menstrual abnormalities (fertility drugs), but we will consider other prescription drug use on a case-by-case basis.
- Special Instructions:
Currently Not Provided
- Keywords:
-
Endometriosis
-
Bone Mineral Density
-
Osteopenia
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Osteoporosis
-
DEXA Scan
-
Menopause
-
Screening
- Recruitment Keyword(s):
-
Endometriosis
-
Bone Mineral Density
-
Osteoporosis
-
Healthy Volunteer
-
HV
- Condition(s):
-
Endometriosis
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Institute of Child Health and Human Development
- Contact(s):
-
Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citation(s):
-
Hearns-Stokes RM, Santoro NF, Simon JA. Surgically induced endometriosis attenuates accrual of bone mineral density in growing rats. Am J Obstet Gynecol. 2001 Feb;184(3):331-5
-
Lopez-Castejon A, Revilla M, Hernandez ER, Villa LF, Rico H, Cortes J. Effect of induced uterine retroversion on bone mass in rats. Eur J Obstet Gynecol Reprod Biol. 1999 Mar;83(1):101-4.
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Comite F, Delman M, Hutchinson-Williams K, DeCherney AH, Jensen P. Reduced bone mass in reproductive-aged women with endometriosis. J Clin Endocrinol Metab. 1989 Oct;69(4):837-42.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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