Bone, Endocrine and Lifestyle Longitudinal Study

Osteoporosis Clinical Trial

— BELLS  

Official title:

Bone, Endocrine and Lifestyle Longitudinal Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02063074
• Other study ID #: HS-13-00789
• Status: Terminated
• Start date: June 2014
• Est. completion date: November 2018

Study information

• Verified date: April 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
United States	Women's Health and Exercise Laboratory, University of southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density		5 years