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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
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers
Post-menopausal osteoporotic women

Sites / Locations

  • Mayo Clinic

Outcomes

Primary Outcome Measures

efficacy of estraderm treatment on osteoporotic women

Secondary Outcome Measures

Full Information

First Posted
March 5, 2007
Last Updated
January 14, 2010
Sponsor
Mayo Clinic
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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

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Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women

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