Age Related Changes in Calciotropic Hormones and Their Im... | NCT00588874

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

NCT00588874

Sponsor

Yale University

Status

Completed

Last Update Posted

Aug 30, 2023Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Low Bone Density

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Pepper Center Pilot Award

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2000Actual

Primary Completion Date

Jul 1, 2002Actual

Completion Date

Dec 1, 2008Actual

First Submitted Date

Dec 27, 2007

First Submission Date that Met QC Criteria

Jan 8, 2008

First Posted Date

Jan 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2023

Last Update Posted Date

Aug 30, 2023Actual

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Label	Type	Description	Intervention Names
1		men 50 yrs of age or older

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara I Gulanski, MD, MPH	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale Center for Clinical Investigation		New Haven	Connecticut	06520	United States

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided