Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00443716
First received: March 5, 2007
Last updated: January 14, 2010
Last verified: January 2010
| Tracking Information | |||||
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| First Received Date ICMJE | March 5, 2007 | ||||
| Last Updated Date | January 14, 2010 | ||||
| Start Date ICMJE | April 1985 | ||||
| Primary Completion Date | April 1989 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
efficacy of estraderm treatment on osteoporotic women | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00443716 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women | ||||
| Official Title ICMJE | Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: estrogen | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | April 1989 | ||||
| Primary Completion Date | April 1989 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Post-menopausal osteoporotic women |
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| Gender | Female | ||||
| Ages | 30 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00443716 | ||||
| Other Study ID Numbers ICMJE | 05-004111, 21b85 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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