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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01738776
Other study ID # S-0916901(REK)
Secondary ID 120000MM
Status Completed
Phase N/A
First received November 14, 2012
Last updated November 30, 2012
Start date September 2009
Est. completion date April 2011

Study information

Verified date November 2012
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Norway University of Oslo, Institute of Clinical Medicine Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary micronutrient association with increased risk of hip fracture Blood was drawn for micronutrient analysis in hip fracture patients and in controls At admission No
Secondary Are micronutrients related to bone turnover markers Blood was drawn for bone turnover analysis. Correlation analysis with micronutrients was performed At admission No
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