Low Bone DensityNCT00588874
Age Related Changes in Calciotropic Hormones and Their Impact on Male Osteoporosis
An observational study of Low Bone Density, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Bone Density
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2000to 1 Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy men 50 yrs of age and older, without a known history of metabolic bone disease or renal insufficiency
Who may be able to join
- healthy men age 50 yrs and older
Who cannot join
- smokers
- known history of metabolic bone disease, known history of hypogonadism or renal insufficiency.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Clinical Investigation
New Haven, Connecticut, 06520
About this study
Official title: 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.
- Conditions
- Low Bone Density
- Keywords
- male osteoporosis, male osteopenia, calciotropic hormones
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | men 50 yrs of age or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density of hip and spine
Measured: measured after screening evaluation
Secondary outcomes (1)
calciotropic hormones, including calcium, PTH and vitamin D metabolites
Measured: measured after screening evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study start1 Oct 2000
- Primary completion1 Jul 2002
- Study completion1 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Bone DensityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Barbara I Gulanski, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588874
- Sponsor's protocol ID
- 11946
- Other IDs
- Pepper Center Pilot Award
- Status last verified
- Aug 2023
- First submitted
- 27 Dec 2007
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Skeletal Effects of Age-related Changes in Calcium and Vitamin D Metabolism in Men
- ClinicalTrials.gov ID
- NCT00588874
- Acronym / sponsor ID
- 11946
- Conditions
- Low Bone Density
- Keywords
- male osteoporosis, male osteopenia, calciotropic hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Oct 2000 (actual)
- Primary completion
- 1 Jul 2002 (actual)
- Study completion
- 1 Dec 2008 (actual)
- First posted
- 9 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –men 50 yrs of age or older |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy men 50 yrs of age and older, without a known history of metabolic bone disease or renal insufficiency
Key inclusion criteria (1 listed)
- healthy men age 50 yrs and older
Key exclusion criteria (2 listed)
- smokers
- known history of metabolic bone disease, known history of hypogonadism or renal insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone density of hip and spine
Time frame: measured after screening evaluation
1 secondary outcome
calciotropic hormones, including calcium, PTH and vitamin D metabolites
Time frame: measured after screening evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara I Gulanski, MD, MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Bone Density, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density of hip and spine (time frame: measured after screening evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.