Nutritional Risk Factors for Hip Fracture: a Case Control Study
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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 |
|---|
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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 |
- 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
- 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 |
|---|
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Cases
Hip fracture patients participating in a randomised controlled trial (RCT) of orthogeriatric care (ClinicalTrials.gov NCT01009268)
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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 |
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.
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| Norway | |
| University of Oslo, Institute of Clinical Medicine | |
| Oslo, Norway, 0424 | |
| 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 May 23, 2013