NCT01816711

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

December 23, 2020

Completed
Last Updated

December 23, 2020

Status Verified

April 1, 2013

Enrollment Period

2.7 years

First QC Date

March 20, 2013

Results QC Date

November 3, 2020

Last Update Submit

November 27, 2020

Conditions

Keywords

Frail elderlyHip fractureVitamin DGeriatrics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • No serum-25(OH)D measurement upon admission
  • Aged 65 or older
  • Living in nursing home or senior housing
  • Admitted to the Geriatric Ward, Aarhus University Hospital
  • No serum-25(OH)D measurement upon admission
  • Hip fracture in the previous ten years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reasearch Unit, Geriatric Department, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Hip FracturesVitamin D Deficiency

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Mette Abildgaard Pedersen
Organization
Aarhus University Hospital

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 23, 2020

Results First Posted

December 23, 2020

Record last verified: 2013-04

Locations