Vitamin D Levels in Frail Elderly Patients With a Hip Fracture

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Levels in Frail Elderly Patients With a Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816711
• Other study ID #: HFVD2012
• Secondary ID: 2007-58-0010
• Status: Completed
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Vitamin D Deficiency

Locations

Country	Name	City	State
Denmark	Reasearch Unit, Geriatric Department, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Upon admission