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Effects of Endometriosis on Bone Mineral Density

Primary Purpose

Endometriosis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Endometriosis focused on measuring Endometriosis, Bone Mineral Density, Osteopenia, Osteoporosis, DEXA Scan, Menopause, Screening, Healthy Volunteer, HV

Eligibility Criteria

40 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

INCLUSION CRITERIA: 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 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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 11, 2006
Last Updated
June 30, 2017
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00291278
Brief Title
Effects of Endometriosis on Bone Mineral Density
Official Title
The Effects of Endometriosis on Bone Mineral Density
Study Type
Observational

2. Study Status

Record Verification Date
February 10, 2009
Overall Recruitment Status
Completed
Study Start Date
February 7, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 10, 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief 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.
Detailed Description
After peaking in the third decade, bone mineral density (BMD) decreases slowly over time, with a more dramatic short-term decline at the time of menopause. Because of the association with osteoporosis and fracture, evaluation of BMD at the time of menopause is recommended, as is identification and treatment of any reversible causes of bone mineral loss. Most studies of women with endometriosis have shown no change or decreased BMD, while rats with induced endometriosis had a marked decrease in BMD. Often, studies in women did not control for factors that are known to affect bone density such as body mass index (BMI), exercise, or calcium intake. To address the question of whether endometriosis is associated with a change in BMD, we previously matched healthy volunteers and endometriosis patients for age, race, BMI, exercise level and calcium intake and compared BMD in the two groups. We found a decrease in BMD in women aged 40 - 50 who had a history of endometriosis, in comparison to women who did not have such a history. This study will expand that experience by studying more women aged 40 - 50 years with a history of endometriosis and matching them to women of the same race with similar age and BMI, who do not have a history of endometriosis. Participants will fill out a questionnaire about their medical, exercise and dietary history and will provide a single blood sample. A bone density study will be done and results will be made available to the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Bone Mineral Density, Osteopenia, Osteoporosis, DEXA Scan, Menopause, Screening, Healthy Volunteer, HV

7. Study Design

Enrollment
80 (false)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: 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 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.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11228482
Citation
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. doi: 10.1067/mob.2001.110025.
Results Reference
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PubMed Identifier
10221617
Citation
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. doi: 10.1016/s0301-2115(98)00304-2.
Results Reference
background
PubMed Identifier
2778037
Citation
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. doi: 10.1210/jcem-69-4-837.
Results Reference
background

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Effects of Endometriosis on Bone Mineral Density

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