Hip FractureNCT01816711
Vitamin D Levels in Frail Elderly Patients With a Hip Fracture
An observational study of Hip Fracture and Vitamin D Deficiency, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to assess whether all frail elderly admitted with hip fracture has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture in frail elderly. Frail elderly are defined as being 65 years of age or older, and living in nursing homes or senior housings. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Vitamin D Deficiency
- How many people
- 447 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Sep 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Cases were frail elderly admitted with a hip fracture to the Orthopaedic Ward at Aarhus University Hospital in the period: 18th of January 2010 to the 1st of October 2012.
Who may be able to join
- Aged 65 or older
- Living in nursing home or senior housing
- Admitted with hip fracture to the Orthopaedic Ward, Aarhus University Hospital
- Aged 65 or older
- Living in nursing home or senior housing
- Admitted to the Geriatric Ward, Aarhus University Hospital
Who cannot join
- No serum-25(OH)D measurement upon admission
- No serum-25(OH)D measurement upon admission
- Hip fracture in the previous ten years
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Reasearch Unit, Geriatric Department, Aarhus University Hospital
Aarhus, 8000
About this study
The purpose of this study is to assess whether all frail elderly admitted with hip fracture has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture in frail elderly.
Frail elderly are defined as being 65 years of age or older, and living in nursing homes or senior housings.
The investigators' hypotheses state that:
- Frail elderly with hip fractures will have a suboptimal level of vitamin D.
- Frail elderly with hip fractures are more likely to have a suboptimal level of vitamin D than frail elderly without any hip fractures during the last ten years.
Read the detailed description
The study examined frail elderly patients, defined as 65 of age or older and living nursing homes or senior housings.
Cases where taken from a Randomised Controlled Trial (NCT01102010), where the included where frail elderly admitted with a hip fractures to the Orthopaedic Surgery Ward at Aarhus University Hospital.
Controls were frail elderly, without a hip fracture in the previous ten years, admitted to the Geriatric Ward at Aarhus University Hospital.
The investigators will look at all eligible patients' files and record their serum-25(OH)D levels upon admission.
According to sample size calculations 92 patients are needed in the case group, and 138 patients in the control group.
The inclusion period will be from the 18th of January 2010 to the 1st of October 2012 for both groups.
- Conditions
- Hip Fracture, Vitamin D Deficiency
- Keywords
- Frail elderly, Hip fracture, Vitamin D, Geriatrics
- Medical subject headings
- Hip Fractures, Vitamin D Deficiency
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 |
|---|---|---|
| Hip fracture, Frail elderly, Non-supplemented | Frail elderly with a hip fracture who did not received vitamin D supplementation | |
| Hip fracture, Frail elderly, Supplemented | Frail elderly with a hip fracture who received vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Suboptimal and Optimal Levels of Vitamin D (Serum-25(OH)D)
Serum-25(OH)D was measured in a blood sample as an indicator of Vitamin D status
Measured: Upon admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816711
- Sponsor's protocol ID
- HFVD2012
- Other IDs
- 2007-58-0010
- Status last verified
- Apr 2013
- First submitted
- 20 Mar 2013
- Last updated
- 23 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Levels in Frail Elderly Patients With a Hip Fracture
- ClinicalTrials.gov ID
- NCT01816711
- Acronym / sponsor ID
- HFVD2012
- Conditions
- Hip Fracture, Vitamin D Deficiency
- Keywords
- Frail elderly, Hip fracture, Vitamin D, Geriatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Posted 23 Dec 2020
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 study is to assess whether all frail elderly admitted with hip fracture has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture in frail elderly.
Frail elderly are defined as being 65 years of age or older, and living in nursing homes or senior housings.
The investigators' hypotheses state that:
- Frail elderly with hip fractures will have a suboptimal level of vitamin D.
- Frail elderly with hip fractures are more likely to have a suboptimal level of vitamin D than frail elderly without any hip fractures during the last ten years.
Detailed description
The study examined frail elderly patients, defined as 65 of age or older and living nursing homes or senior housings.
Cases where taken from a Randomised Controlled Trial (NCT01102010), where the included where frail elderly admitted with a hip fractures to the Orthopaedic Surgery Ward at Aarhus University Hospital.
Controls were frail elderly, without a hip fracture in the previous ten years, admitted to the Geriatric Ward at Aarhus University Hospital.
The investigators will look at all eligible patients' files and record their serum-25(OH)D levels upon admission.
According to sample size calculations 92 patients are needed in the case group, and 138 patients in the control group.
The inclusion period will be from the 18th of January 2010 to the 1st of October 2012 for both groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip fracture, Frail elderly, Non-supplemented | – | –Frail elderly with a hip fracture who did not received vitamin D supplementation |
| Hip fracture, Frail elderly, Supplemented | – | –Frail elderly with a hip fracture who received vitamin D supplementation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Cases were frail elderly admitted with a hip fracture to the Orthopaedic Ward at Aarhus University Hospital in the period: 18th of January 2010 to the 1st of October 2012.
Key inclusion criteria (6 listed)
- Aged 65 or older
- Living in nursing home or senior housing
- Admitted with hip fracture to the Orthopaedic Ward, Aarhus University Hospital
- Aged 65 or older
- Living in nursing home or senior housing
Key exclusion criteria (3 listed)
- No serum-25(OH)D measurement upon admission
- No serum-25(OH)D measurement upon admission
- Hip fracture in the previous ten years
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
Number of Participants With Suboptimal and Optimal Levels of Vitamin D (Serum-25(OH)D)
Time frame: Upon admission
Serum-25(OH)D was measured in a blood sample as an indicator of Vitamin D status
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hip Fracture and Vitamin D Deficiency, run by University of Aarhus at 1 site in Denmark.
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 6 inclusion and 3 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 23 Dec 2020. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Suboptimal and Optimal Levels of Vitamin D (Serum-25(OH)D) (time frame: Upon admission). 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 23 Dec 2020.