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

This study is ongoing, but not recruiting participants.

First Received: December 27, 2007 Last Updated: January 8, 2008 History of Changes

Sponsors and Collaborators:	Yale University National Institute on Aging (NIA)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00588874

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

MedlinePlus related topics: Calcium Osteoporosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Cross-Sectional
Official Title:	Pilot Study to Assess the Skeletal Effects of Age-Related Changes in Calcium and Vitamin D Metabolism in Men

Further study details as provided by Yale University:

Primary Outcome Measures:

Bone density of hip and spine [ Time Frame: measured after screening evaluation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

calciotropic hormones, including calcium, PTH and vitamin D metabolites [ Time Frame: measured after screening evaluation ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
Genders 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

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

No publications provided

Responsible Party:	Yale University School of Medicine ( Barbara I. Gulanski, MD, MPH )
Study ID Numbers:	11946, Pepper Center Pilot Award
Study First Received:	December 27, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00588874 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

male osteoporosis
male osteopenia
calciotropic hormones

Study placed in the following topic categories:

Calcium, Dietary
Vitamin D
Vitamins
Osteoporosis
Hormones

ClinicalTrials.gov processed this record on May 07, 2009