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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Yale University.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00588874
First received: December 27, 2007
Last updated: January 8, 2008
Last verified: December 2007
  Purpose
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
Low Bone Density

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yale University:

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

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

Enrollment: 24
Study Start Date: October 2000
Estimated Study Completion Date: December 2008
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
men 50 yrs of age or older

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 27, 2007
Last Updated: January 8, 2008

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

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

ClinicalTrials.gov processed this record on June 26, 2017