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Clinical Trials/NCT02063074
NCT02063074
Terminated
Not Applicable

Bone, Endocrine and Lifestyle Longitudinal Study

University of Southern California1 site in 1 country100 target enrollmentJune 2014
ConditionsOsteoporosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
University of Southern California
Enrollment
100
Locations
1
Primary Endpoint
Bone mineral density
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this proposal is to determine the long-terms effects of hormone and lifestyle factors on bone health in young women over a 20-year time period. It is our primary hypothesis that premenopausal women with irregular periods or endocrine issues related to estrogen will have significantly poorer low back and hip bone health when compared to regularly menstruating women. It is our secondary hypothesis that long-term assessment of changes in endocrine function and lifestyle behaviors will assist in establishing risk factors for osteoporosis in young women. This study will include 1000 premenopausal women. The women will participate in the collection of a blood sample, bone scan, body fat measures, and lifestyle questionnaires. In addition, we hope to use this initial study to develop a group of women to follow throughout menopause, with additional visits occurring every 5 years over the course of their life.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
November 2018
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christina Dieli-Conwright

Assistant Professor

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • Women at least 18 years of age
  • free from any uncontrolled chronic disease that may affect bone mass
  • Not pregnant

Exclusion Criteria

  • Women recently diagnosed with uncontrolled chronic disease(s) at time of enrollment known to affect bone mass, including but not limited to metabolic and endocrine diseases (specifically, diseases of the thyroid and parathyroid glands), osteoporosis, and those women who have taken prophylactic bone density agents, such as Fosamax.

Outcomes

Primary Outcomes

Bone mineral density

Time Frame: 5 years

Study Sites (1)

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