Hip FractureNCT00523575
Nutritional Intervention in Hip Fracture Patients
A study testing Cubitan in people with Hip Fracture and Malnutrition, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
Hip fractures are highly prevalent and are expected to increase due to the ageing population. Malnutrition is often present in these patients and is associated with prolonged convalescence, lower mobility, lower mental function, lower quality of life and higher complication rate. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hip Fracture, Malnutrition
- What is being tested?
- Cubitan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesNetherlands
- Study dates
- Aug 2007to Jun 2010
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to one of the participating hospitals because of a proximal femur fracture
- Age 55 years and older
Who cannot join
- Periprosthetic or pathologic fracture
- Diseases of bone metabolism, e.g. Paget, primary/secondary bone tumors, hyperparathyroidism, M. Kahler
- Life expectation of less than one year due to underlying disease (e.g. cancer)
- Presence of dementia or other severely impaired cognitive function
- Inability to communicate in Dutch language
- Nutritional intervention prior to admission
- Patients who are bedridden
- Patients who are too ill or for any other reason not able to participate adequately in follow-up
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Atrium MC
Heerlen, 6419 PC
Maastricht University Hospital
Maastricht, 6229 HA
Maaslandziekenhuis
Sittard, 6131 BK
About this study
Official title: Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture
Hip fractures are highly prevalent and are expected to increase due to the ageing population. Malnutrition is often present in these patients and is associated with prolonged convalescence, lower mobility, lower mental function, lower quality of life and higher complication rate. Nutritional intervention starting soon after hospital admission might reduce complication rate and total length-of-stay by improving nutritional and functional status. Research questions are:
- Does nutritional intervention reduce total length-of-stay?
- Is nutritional intervention cost-effective?
- Can nutritional screening contribute to targeting of nutritional intervention, and thereby reduce costs without loss of effectiveness?
Patients randomized to the intervention group will receive oral nutritional supplements (protein and energy enriched) and regular dietetic counselling during hospitalisation and after discharge at patients' homes for 3 months. Patients in the control group will receive usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6 months after inclusion.
- Conditions
- Hip Fracture, Malnutrition
- Being tested
- Cubitan
- Keywords
- Elderly, Osteoporosis, hip fracture, malnutrition, nutritional support
- Medical subject headings
- Hip Fractures, Malnutrition, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CubitanDietary supplement
Also called Nutricia: Cubitan
400 ml/d
| Study group | Role | What they receive |
|---|---|---|
| C | No intervention | Usual nurse and dietetic care |
| I | Experimental | Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling. Receives: Dietary Supplement: Cubitan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total length of hospital stay and rehabilitation clinics
Measured: baseline, 3 months and 6 months after inclusion
Secondary outcomes (3)
Nutritional status, hip functionality, physical disability, fatigue, quality of life.
Measured: baseline, 3 months and 6 months after inclusion
Cost questionnaire, informal care questionnaire.
Measured: baseline, 3 months and 6 months after inclusion
Rate of complications
Measured: baseline, 3 months and 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- P C Dagnelie, PhD, Principal investigator, Maastricht University - Faculty of Health Medicine and Life Sciences - Department of EpidemiologieP LM Reijven, PhD, Principal investigator, Maastricht University Hospital - Department of Dietetics & Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523575
- Sponsor's protocol ID
- MEC 06-3-098
- Other IDs
- ZonMw 80-007022-98-07510
- Status last verified
- Jul 2011
- First submitted
- 29 Aug 2007
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wyers CE, Reijven PLM, Breedveld-Peters JJL, Denissen KFM, Schotanus MGM, van Dongen MCJM, Eussen SJPM, Heyligers IC, van den Brandt PA, Willems PC, van Helden S, Dagnelie PC. Efficacy of Nutritional Intervention in Elderly After Hip Fracture: A Multicenter Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2018 Sep 11;73(10):1429-1437. doi: 10.1093/gerona/gly030.
PubMed 30204859Breedveld-Peters JJ, Reijven PL, Wyers CE, van Helden S, Arts JJ, Meesters B, Prins MH, van der Weijden T, Dagnelie PC. Integrated nutritional intervention in the elderly after hip fracture. A process evaluation. Clin Nutr. 2012 Apr;31(2):199-205. doi: 10.1016/j.clnu.2011.10.004. Epub 2011 Oct 28.
PubMed 22035956Wyers CE, Breedveld-Peters JJ, Reijven PL, van Helden S, Guldemond NA, Severens JL, Verburg AD, Meesters B, van Rhijn LW, Dagnelie PC. Efficacy and cost-effectiveness of nutritional intervention in elderly after hip fracture: design of a randomized controlled trial. BMC Public Health. 2010 Apr 27;10:212. doi: 10.1186/1471-2458-10-212.
PubMed 20423469
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture
- ClinicalTrials.gov ID
- NCT00523575
- Acronym / sponsor ID
- MEC 06-3-098
- Conditions
- Hip Fracture, Malnutrition
- Keywords
- Elderly, Osteoporosis, hip fracture, malnutrition, nutritional support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Aug 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Aug 2007 (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.
Hip fractures are highly prevalent and are expected to increase due to the ageing population. Malnutrition is often present in these patients and is associated with prolonged convalescence, lower mobility, lower mental function, lower quality of life and higher complication rate. Nutritional intervention starting soon after hospital admission might reduce complication rate and total length-of-stay by improving nutritional and functional status. Research questions are:
- Does nutritional intervention reduce total length-of-stay?
- Is nutritional intervention cost-effective?
- Can nutritional screening contribute to targeting of nutritional intervention, and thereby reduce costs without loss of effectiveness?
Patients randomized to the intervention group will receive oral nutritional supplements (protein and energy enriched) and regular dietetic counselling during hospitalisation and after discharge at patients' homes for 3 months. Patients in the control group will receive usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6 months after inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C | No intervention | –Usual nurse and dietetic care |
| I | Experimental | Dietary Supplement: CubitanIntensive nutritional support composed of oral dietary supplement combined with dietetic counselling. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admission to one of the participating hospitals because of a proximal femur fracture
- Age 55 years and older
Key exclusion criteria (8 listed)
- Periprosthetic or pathologic fracture
- Diseases of bone metabolism, e.g. Paget, primary/secondary bone tumors, hyperparathyroidism, M. Kahler
- Life expectation of less than one year due to underlying disease (e.g. cancer)
- Presence of dementia or other severely impaired cognitive function
- Inability to communicate in Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CubitanAlso: Nutricia: Cubitan400 ml/d | Dietary supplement | I |
Primary outcome
Total length of hospital stay and rehabilitation clinics
Time frame: baseline, 3 months and 6 months after inclusion
3 secondary outcomes
Nutritional status, hip functionality, physical disability, fatigue, quality of life.
Time frame: baseline, 3 months and 6 months after inclusion
Cost questionnaire, informal care questionnaire.
Time frame: baseline, 3 months and 6 months after inclusion
Rate of complications
Time frame: baseline, 3 months and 6 months after inclusion
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 20 Jul 2011.
- Derived from this study: PubMed 30204859Wyers CE, Reijven PLM, Breedveld-Peters JJL, Denissen KFM, Schotanus MGM, van Dongen MCJM, Eussen SJPM, Heyligers IC, van den Brandt PA, Willems PC, van Helden S, Dagnelie PC. Efficacy of Nutritional Intervention in Elderly After Hip Fracture: A Multicenter Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2018 Sep 11;73(10):1429-1437. doi: 10.1093/gerona/gly030.
- Derived from this study: PubMed 22035956Breedveld-Peters JJ, Reijven PL, Wyers CE, van Helden S, Arts JJ, Meesters B, Prins MH, van der Weijden T, Dagnelie PC. Integrated nutritional intervention in the elderly after hip fracture. A process evaluation. Clin Nutr. 2012 Apr;31(2):199-205. doi: 10.1016/j.clnu.2011.10.004. Epub 2011 Oct 28.
- Derived from this study: PubMed 20423469Wyers CE, Breedveld-Peters JJ, Reijven PL, van Helden S, Guldemond NA, Severens JL, Verburg AD, Meesters B, van Rhijn LW, Dagnelie PC. Efficacy and cost-effectiveness of nutritional intervention in elderly after hip fracture: design of a randomized controlled trial. BMC Public Health. 2010 Apr 27;10:212. doi: 10.1186/1471-2458-10-212.
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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.
P C Dagnelie, PhD principal investigator
Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiologie
P LM Reijven, PhD principal investigator
Maastricht University Hospital - Department of Dietetics & Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cubitan in people with Hip Fracture and Malnutrition, run by Maastricht University Medical Center at 3 sites in Netherlands.
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 2 inclusion and 8 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 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Total length of hospital stay and rehabilitation clinics (time frame: baseline, 3 months and 6 months after inclusion). 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 NCT00523575, which also lists 3 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 20 Jul 2011.