Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Yale University.
Recruitment status was  Active, not recruiting
Information provided by:
Yale University Identifier:
First received: December 27, 2007
Last updated: January 8, 2008
Last verified: December 2007

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.

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 ] [ 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 ]

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)
men 50 yrs of age or older


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


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 identifier: NCT00588874

United States, Connecticut
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Principal Investigator: Barbara I Gulanski, MD, MPH Yale University
  More Information

No publications provided

Responsible Party: Barbara I. Gulanski, MD, MPH, Yale University School of Medicine 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
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
male osteoporosis
male osteopenia
calciotropic hormones processed this record on February 27, 2015