Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291278
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-02-11
Brief Title:
Effects of Endometriosis on Bone Mineral Density
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Endometriosis on Bone Mineral Density
Status:
COMPLETED
Status Verified Date:
2009-02-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-CH-0091 | None | None | None |