NCT00588874

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

December 27, 2007

Last Update Submit

August 29, 2023

Conditions

Low Bone Density

Keywords

male osteoporosismale osteopeniacalciotropic hormones

Outcome Measures

Primary Outcomes (1)

  • Bone density of hip and spine

    measured after screening evaluation

Secondary Outcomes (1)

  • calciotropic hormones, including calcium, PTH and vitamin D metabolites

    measured after screening evaluation

Study Arms (1)

1

men 50 yrs of age or older

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy men 50 yrs of age and older, without a known history of metabolic bone disease or renal insufficiency

You may qualify if:

  • healthy men age 50 yrs and older

You may not qualify if:

  • smokers
  • known history of metabolic bone disease, known history of hypogonadism or renal insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigation

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Barbara I Gulanski, MD, MPH

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 27, 2007

First Posted

January 9, 2008

Study Start

October 1, 2000

Primary Completion

July 1, 2002

Study Completion

December 1, 2008

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(1)