This trial is active, not recruiting.

Condition low bone density
Sponsor Yale University
Collaborator National Institute on Aging (NIA)
Start date October 2000
End date July 2002
Trial size 24 participants
Trial identifier NCT00588874, 11946, Pepper Center Pilot Award


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
men 50 yrs of age or older

Primary Outcomes

Bone density of hip and spine
time frame: measured after screening evaluation

Secondary Outcomes

calciotropic hormones, including calcium, PTH and vitamin D metabolites
time frame: measured after screening evaluation

Eligibility Criteria

Male participants at least 50 years old.

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.

Additional Information

Official title Pilot Study to Assess the Skeletal Effects of Age-Related Changes in Calcium and Vitamin D Metabolism in Men
Principal investigator Barbara I Gulanski, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by Yale University.