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Bone, Endocrine and Lifestyle Longitudinal Study (BELLS)

University of Southern California logo

University of Southern California

Status

Terminated

Conditions

Osteoporosis

Study type

Observational

Funder types

Other

Identifiers

NCT02063074
HS-13-00789

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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