Nutritional Risk Factors for Hip Fracture: a Case Control Study

NCT01738776 | Completed

• 2 other identifiers: S-0916901(REK)120000MM
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Fracture

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• micronutrient association with increased risk of hip fracture

  Blood was drawn for micronutrient analysis in hip fracture patients and in controls

  At admission

Secondary Outcomes (1)

• Are micronutrients related to bone turnover markers

  At admission

Study Arms (2)

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 Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

University of Oslo, Institute of Clinical Medicine

Oslo, 0424, Norway

Location

Related Publications (2)

• Torbergsen AC, Watne LO, Frihagen F, Wyller TB, Mowe M. Effects of nutritional intervention upon bone turnover in elderly hip fracture patients. Randomized controlled trial. Clin Nutr ESPEN. 2019 Feb;29:52-58. doi: 10.1016/j.clnesp.2017.11.012. Epub 2018 Oct 30.

  PMID: 30661701 DERIVED

• Torbergsen AC, Watne LO, Wyller TB, Frihagen F, Stromsoe K, Bohmer T, Mowe M. Micronutrients and the risk of hip fracture: Case-control study. Clin Nutr. 2017 Apr;36(2):438-443. doi: 10.1016/j.clnu.2015.12.014. Epub 2015 Dec 23.

  PMID: 26795217 DERIVED

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

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Morten Mowe, PhD

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nutritionist

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 30, 2012
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

NO (1)