NCT00443716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 1985

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1985

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1989

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1989

Completed
17.9 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

4 years

First QC Date

March 5, 2007

Last Update Submit

January 14, 2010

Conditions

OsteoporosisPostmenopausal

Outcome Measures

Primary Outcomes (1)

  • efficacy of estraderm treatment on osteoporotic women

Interventions

estrogenDRUG

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Post-menopausal osteoporotic women

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Estrogens

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • B. Lawrence Riggs, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 6, 2007

Study Start

April 1, 1985

Primary Completion

April 1, 1989

Study Completion

April 1, 1989

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(1)