Hip Fracture Surgery and Oral Nutritional Supplements

NCT01505985 | Terminated Phase 3

• 1 other identifier: NES1026CLI
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Fracture

Keywords

Hip fracture; SPPB; Functional recovery

Outcome Measures

Primary Outcomes (1)

• The Short Physical Performance Battery (SPPB)

  6 months

Secondary Outcomes (3)

• Nutritional status

  6 months

• Quality of Life

  6 months

• Muscle strength

  6 months

Study Arms (2)

Specialized Oral Nutritional Supplement

EXPERIMENTAL

Dietary Supplement: Oral nutritional Supplement

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Oral nutritional Supplement DIETARY_SUPPLEMENT

Specialized nutritional supplement for seniors

Specialized Oral Nutritional Supplement

Placebo DIETARY_SUPPLEMENT

placebo product with no specific nutrients

Placebo

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

University of Zurich,Dept. of Rheumatology and Institute of Physical Medicine,

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Heike Bischoff-Ferrari,, MD, DrPH

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 9, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

CH (1)