Hip FractureNCT01738776
Nutritional Risk Factors for Hip Fracture: a Case Control Study
An observational study of Hip Fracture, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Fracture
- How many people
- 184 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Cases are admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
micronutrient association with increased risk of hip fracture
Blood was drawn for micronutrient analysis in hip fracture patients and in controls
Measured: At admission
Secondary outcomes (1)
Are micronutrients related to bone turnover markers
Blood was drawn for bone turnover analysis. Correlation analysis with micronutrients was performed
Measured: At admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Anne Torbergsen, Oslo University Hospital
- Investigators
- Morten Mowe, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738776
- Sponsor's protocol ID
- S-0916901(REK)
- Other IDs
- 120000MM
- Status last verified
- Nov 2012
- First submitted
- 14 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30661701Torbergsen 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.
PubMed 26795217
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Risk Factors for Hip Fracture: a Case Control Study
- ClinicalTrials.gov ID
- NCT01738776
- Acronym / sponsor ID
- S-0916901(REK)
- Conditions
- Hip Fracture
- Keywords
- hip fracture, risk factors, vitamin K1, vitamin D, bone turnover markers, osteocalcin, undercarboxylated osteocalcin, bone specific alkaline phosphatase (BALP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Cases are admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Are micronutrients related to bone turnover markers
Time frame: At admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Derived from this study: PubMed 30661701Torbergsen 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.
- Derived from this study: PubMed 26795217Torbergsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Mowe, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
micronutrient association with increased risk of hip fracture (time frame: At admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.