OsteoporosisNCT00443716
Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
A study testing estrogen in people with Osteoporosis and Postmenopausal, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- estrogen
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1985to Apr 1989
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Post-menopausal osteoporotic women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- estrogen
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estrogenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of estraderm treatment on osteoporotic women
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startApr 1985
- Primary completionApr 1989
- Study completionApr 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- B. Lawrence Riggs, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443716
- Sponsor's protocol ID
- 05-004111
- Other IDs
- 21b85
- Status last verified
- Jan 2010
- First submitted
- 5 Mar 2007
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
- ClinicalTrials.gov ID
- NCT00443716
- Acronym / sponsor ID
- 05-004111
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 1985
- Primary completion
- Apr 1989 (actual)
- Study completion
- Apr 1989 (actual)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estrogen | Drug | – |
Primary outcome
efficacy of estraderm treatment on osteoporotic women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B. Lawrence Riggs, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing estrogen in people with Osteoporosis and Postmenopausal, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of estraderm treatment on osteoporotic women. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2010.