Vitamin D Levels in Frail Elderly Patients With a Hip Fracture

November 27, 2020 updated by: University of Aarhus

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:

  1. Frail elderly with hip fractures will have a suboptimal level of vitamin D.
  2. 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

447

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

  • Denmark
      • Aarhus, Denmark, 8000
        • Reasearch Unit, Geriatric Department, Aarhus University Hospital

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria, Cases:

  • Aged 65 or older
  • Living in nursing home or senior housing
  • Admitted with hip fracture to the Orthopaedic Ward, Aarhus University Hospital

Exclusion Criteria, Cases:

  • No serum-25(OH)D measurement upon admission

Inclusion Criteria, Controls:

  • Aged 65 or older
  • Living in nursing home or senior housing
  • Admitted to the Geriatric Ward, Aarhus University Hospital

Exclusion Criteria, Controls:

  • No serum-25(OH)D measurement upon admission
  • Hip fracture in the previous ten years

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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Upon admission

Collaborators and Investigators

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

Sponsor

University of Aarhus

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

January 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

November 27, 2020

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFVD2012
  • 2007-58-0010 (Other Identifier: Data tilsynet)

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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