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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01505985
Other study ID # NES1026CLI
Secondary ID
Status Terminated
Phase Phase 3
First received December 22, 2011
Last updated November 22, 2013
Start date January 2012
Est. completion date September 2013

Study information

Verified date November 2013
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

Senior hip fracture patients are the most vulnerable to malnutrition and protein deficiency. Low protein intake, like vitamin D deficiency, contribute to an increased risk for hip fracture. Notably, several clinical trials with protein supplementation in senior hip fracture patients resulted in fewer deaths, shorter hospital stay, and a higher likelihood of return to independent living. The proposal is to test the effect of an oral nutritional supplement (ONS) which has been designed to meet the specific nutrient needs of senior bone and muscle health. The hypothesis is that this ONS will improve functional recovery after hip fracture (as measured by Short Physical Performance Battery (SPPB)), improve quality of life, improve muscle mass, and- decrease falls and hospital re-admission after hip fracture.


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Age (70+);

- Had an acute hip fracture and surgical treatment

- Able to walk at least 3 meters without assistance of another person, with or without a walking aid other than a wheeled walker prior to hip fracture MMSE >=18 (proxy will be informed in addition if MMS-score = 24)

- Able to perform the SPPB at baseline

- No prior hip fracture

- Patient (and/or his/her legal representatives/relatives) understands the study procedure, alternative treatments available and risks involved with the study, and voluntarily agrees to participate by giving his/her (or his/her legal representative's/relatives) written informed consent.

Exclusion Criteria:

- Baseline visit can not be performed between the second and tenth postoperative day.

- Milk protein allergy

- Patients with conservative treatment for hip fracture

- Serum calcium adjusted for albumin of > 2.6 mmol/L

- Pathologic fracture in the last year (except for fractures due to osteoporosis)

- Chemo therapy / Radiation /antihormonal therapy due to cancer in the last year

- Treatment which has an effect on calcium metabolism (e.g. PTH, calcitonin, chronic cortisone intake > 5mg/day in the last 12 months (except for inhalation and sporadic infiltration))

- Oral vitamin D intake of more than 1000 IU per day during the last 3 months before the study

- Unwilling to stop multi-vitamin, calcium supplementation, and vitamin D supplementation during the trial (maximal calcium supplement intake 250mg/d; no additional vitamin D supplementation). We will inform the treating physician that we initiated vitamin D supplementation as standard of care.

- Severe visual or hearing impairment

- Unwilling or unable to take study medication

- Diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope) BMI = 40

- Estimated creatinine clearance < 15 ml/min (estimated Creatinine Clearance cockcroft and Gault)

- Malabsorption syndrome (celiac diseases, inflammatory bowel disease, hepatic and/or pancreas dysfunction)

- Diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary hyperparathyroidism

- Kidney stone in the last 10 years

- Patient heavily consumes alcohol containing products defined as greater than (>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.

- Patients who are planning a stay in a "sunny" location (e.g. winter sun resort) for more than one month during the trial

- Medication which has an effect on serum 25-hydroxyvitamin D level (e.g. certain anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin) M. Paget (Ostitis deformans)

- Inflammatory arthritis (e.g. rheumatoid arthritis, reiter syndrome, psoriasis arthritis)

- Uncontrolled metabolic conditions, or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult

- Severe acute and/or chronic disease that makes the performance of the study assessments impossible (e.g. severe infection/sepsis, myocardial infarction, heart failure, respiratory failure or renal failure);

- Patient is taking peripherally acting anti-adiposity drugs (e.g. Xenical®, formoline L112®, (Acomplia®))

- Patients taking protein supplements (>15g per serving more than once a week) or are unwilling to stop any protein supplements during the trial Participation in a study in the last 6 month, except for studies without drug-application, or any influence of the study-medication can be excluded

- Patient is unlikely to adhere to the study procedures, to keep appointments, or is planning to relocate during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Oral nutritional Supplement
Specialized nutritional supplement for seniors
Placebo
placebo product with no specific nutrients

Locations

Country Name City State
Switzerland University of Zurich,Dept. of Rheumatology and Institute of Physical Medicine, Zurich

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Short Physical Performance Battery (SPPB) 6 months No
Secondary Nutritional status 6 months No
Secondary Quality of Life 6 months No
Secondary Muscle strength 6 months No
See also
  Status Clinical Trial Phase
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Completed NCT02197065 - Pilot Study of Atorvastatin for Orthopedic Surgery Patients Phase 2
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Completed NCT01714336 - Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery? Phase 4
Terminated NCT01667913 - Reliability of 6-Minutes Walking Test in Hip Fracture Patients N/A
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A
Completed NCT01174589 - Training of Patients With Hip Fracture Phase 2
Active, not recruiting NCT02362971 - External Validity of a Randomized Trial in Patients With a Femoral Neck Fracture N/A
Completed NCT01382875 - The Comparison of Comprehensive Multi-disciplinary Program and Conventional Care Program on Fragility Fracture Elderly Phase 3
Completed NCT02591342 - Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture N/A
Completed NCT01738776 - Nutritional Risk Factors for Hip Fracture: a Case Control Study N/A
Suspended NCT00521716 - Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation N/A
Terminated NCT00128115 - Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032) Phase 2
Active, not recruiting NCT00345488 - Fast Track Admittance of Hip Fracture Patients Phase 4
Completed NCT02409082 - Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures N/A
Recruiting NCT04626934 - Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients N/A
Completed NCT06001996 - Comparison of Intraoperative- Postoperative Effects of Pericapsular Nerve Block and Fascia Iliaca Block in Hip Fracture
Recruiting NCT02635763 - Peripheral Nerve Blocks in Elderly Patients With Hip Fracture N/A
Completed NCT00848913 - Strength Training After Hip Fracture Surgery N/A
Completed NCT02190903 - A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia N/A