Nutritional Risk Factors for Hip Fracture: a Case Control Study

November 30, 2012 updated by: Anne Torbergsen, Oslo University Hospital
Low Body Mass Index (BMI) is a risk factor for hip fracture, but it is unknown if it is the low BMI per se that increases risk of hip fracture or if specific micro-nutrients contribute. The investigators want to elucidate this aspect in a case control study studying micronutrients in serum and bone turnover markers of hip fracture patients compared with controls of the same age.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

184

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

  • Norway
      • Oslo, Norway, 0424
        • University of Oslo, Institute of Clinical Medicine

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cases: The first 116 patients of an ongoing RCT were included consecutively and examined by blood samples pre operatively for nutrition and hormone analysis. The catchment area for the cases was the city of Oslo, Norway.

A control group, at the same age with no history of hip fracture, was drawn at random from inhabitants aged 60 - 100 years (median age 82 years) at the census files of Oslo in 2005.

Description

Inclusion Criteria:

Cases are admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.

Exclusion Criteria:

  • Hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a higher level than 1 metre). One recent fracture in addition to the hip fracture (e.g. radius or shoulder) is acceptable.
  • Regarded as moribund at admittance.
  • Absence of a valid informed consent or assent.

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
Cases
Hip fracture patients participating in a randomised controlled trial (RCT) of orthogeriatric care (ClinicalTrials.gov NCT01009268)
Controls
A group of voluntary elderly persons without a history of hip fracture, recruited specifically for this purpose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
micronutrient association with increased risk of hip fracture
Time Frame: At admission
Blood was drawn for micronutrient analysis in hip fracture patients and in controls
At admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Are micronutrients related to bone turnover markers
Time Frame: At admission
Blood was drawn for bone turnover analysis. Correlation analysis with micronutrients was performed
At admission

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

Investigators

  • Study Chair: Morten Mowe, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-0916901(REK)
  • 120000MM (Other Grant/Funding Number: Oslo University Hospital)

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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