Nutritional Risk Factors for Hip Fracture: a Case Control Study

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Anne Torbergsen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01738776
First received: November 14, 2012
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition
Hip Fracture

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Nutritional Risk Factors for Hip Fracture: a Case Control Study

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • micronutrient association with increased risk of hip fracture [ Time Frame: At admission ] [ Designated as safety issue: No ]
    Blood was drawn for micronutrient analysis in hip fracture patients and in controls


Secondary Outcome Measures:
  • Are micronutrients related to bone turnover markers [ Time Frame: At admission ] [ Designated as safety issue: No ]
    Blood was drawn for bone turnover analysis. Correlation analysis with micronutrients was performed


Biospecimen Retention:   Samples With DNA

For vitamin and hormone analysis serum was collected For some vitamin analysis EDTA blood was collected For RNA analysis fullblood was collected


Enrollment: 184
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01738776

Locations
Norway
University of Oslo, Institute of Clinical Medicine
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
Study Chair: Morten Mowe, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Anne Torbergsen, Clinical Nutritionist, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01738776     History of Changes
Other Study ID Numbers: S-0916901(REK), 120000MM
Study First Received: November 14, 2012
Last Updated: November 30, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
hip fracture
risk factors
vitamin K1
vitamin D
bone turnover markers
osteocalcin
undercarboxylated osteocalcin
bone specific alkaline phosphatase (BALP)
insulin like growth factor 1 (IGF1)
parathyroid hormone (PTH)

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 22, 2014