Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
Primary Purpose
Osteoporosis, Postmenopausal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
estrogen
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Post-menopausal osteoporotic women
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
efficacy of estraderm treatment on osteoporotic women
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00443716
Brief Title
Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
Official Title
Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 1985 (undefined)
Primary Completion Date
April 1989 (Actual)
Study Completion Date
April 1989 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effect of estrogen treatment on adipocytic and osteoblastic parameters by histomorphometrically measuring adipocyte volume (AV/TV) and adipocyte numbers in goldner's stained iliac crest bone biopsy specimens collected from subjects recruited in the study (IRB number 21B85). The adipocytic parameters will be then correlated with osteoblastic parameters obtained previously during the course of the initai study involving the effect of transdermal estrogen on bone turnover in postmenopausal osteoporotic women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
estrogen
Primary Outcome Measure Information:
Title
efficacy of estraderm treatment on osteoporotic women
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Post-menopausal osteoporotic women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. Lawrence Riggs, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
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