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Age Related Changes in Calciotropic Hormones and Their Impact on Male Osteoporosis

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ClinicalTrials.gov Identifier: NCT00588874
Recruitment Status : Unknown
Verified December 2007 by Yale University.
Recruitment status was:  Active, not recruiting
First Posted : January 9, 2008
Last Update Posted : January 9, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this pilot study is to generate preliminary data regarding the skeletal effects of age-related changes in calcium and vitamin D metabolism in older men.

Condition or disease
Low Bone Density

Study Design

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pilot Study to Assess the Skeletal Effects of Age-Related Changes in Calcium and Vitamin D Metabolism in Men
Study Start Date : October 2000
Primary Completion Date : July 2002
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
men 50 yrs of age or older


Outcome Measures

Primary Outcome Measures :
  1. Bone density of hip and spine [ Time Frame: measured after screening evaluation ]

Secondary Outcome Measures :
  1. calciotropic hormones, including calcium, PTH and vitamin D metabolites [ Time Frame: measured after screening evaluation ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy men 50 yrs of age and older, without a known history of metabolic bone disease or renal insufficiency
Criteria

Inclusion Criteria:

  • healthy men age 50 yrs and older

Exclusion Criteria:

  • smokers
  • known history of metabolic bone disease, known history of hypogonadism or renal insufficiency.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588874


Locations
United States, Connecticut
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Barbara I Gulanski, MD, MPH Yale University
More Information

Responsible Party: Barbara I. Gulanski, MD, MPH, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00588874     History of Changes
Other Study ID Numbers: 11946
Pepper Center Pilot Award
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: December 2007

Keywords provided by Yale University:
male osteoporosis
male osteopenia
calciotropic hormones

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases