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

August 29, 2023 updated by: Yale University

Pilot Study to Assess the Skeletal Effects of Age-related Changes in Calcium and Vitamin D Metabolism in Men

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Center for Clinical Investigation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
men 50 yrs of age or older

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone density of hip and spine
Time Frame: measured after screening evaluation
measured after screening evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
calciotropic hormones, including calcium, PTH and vitamin D metabolites
Time Frame: measured after screening evaluation
measured after screening evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Barbara I Gulanski, MD, MPH, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2000

Primary Completion (Actual)

July 1, 2002

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

January 8, 2008

First Posted (Estimated)

January 9, 2008

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11946
  • Pepper Center Pilot Award

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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