Back to resultsNutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
Primary Purpose
Hip Fractures
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Juven
Centrum Silver 50+
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Older adults, Hip surgery
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Male or female, aged 65-89 years Closed fracture of the proximal femur including the anatomic areas of femoral neck, intertrochanteric and subtrochanteric region Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per orthopaedic surgeon Ability to take oral medication and be willing to adhere to the study drug regimen and to the nutritional guidance provided by nutritional experts. Exclusion Criteria: Patients with open fractures Surgical treatment other than surgical fixation or arthroplasty, such as proximal femur resection Known allergic reactions to components of the study drugs or who do not tolerate oral nutritional supplementation (e.g. total parenteral nutrition or food allergies) Decisional impairment Prisoners
Sites / Locations
- University Health System
- UT Health San Antonio Department of Orthopedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional Supplements
Control
Arm Description
Juven and Centrum Silver 50+ will be administered to this group
Standard of care procedures
Outcomes
Primary Outcome Measures
Assessment of surgical complications at 26 weeks
Number of subjects that experienced any complications post surgery
Secondary Outcome Measures
Hospital Readmissions
Number of hospital re-admissions
Secondary fractures
Number of secondary fractures that occurred post surgery
Grip strength
Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds
Quality of Life Survey (Short-form 36 Health (SF-36))
Change in Health related quality of life (QOL) survey, a 36 item survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Full Information
NCT ID
NCT05971173
First Posted
July 14, 2023
Last Updated
July 31, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05971173
Brief Title
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
Official Title
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality.
Detailed Description
This collaborative pilot study is led by a PI who is a board-certified orthopaedic surgeon with extensive experience in the care of older adults with hip fractures. In addition, the multidisciplinary study team includes a research health scientist with vast experience in nutrition, preventive health, and gerontology. The study team will also be supported by a physical therapist and researcher in the field of rehabilitation of older adults with musculoskeletal disorders. Furthermore, an occupational therapist with expertise in rehabilitation science, conduct of pilot studies, and analysis of interview data will play an important role in this study. Moreover, the statistical analyses will be performed by an expert statistical consultant from our institution, who will be reimbursed on a fee for service basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Older adults, Hip surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutritional Supplements
Arm Type
Experimental
Arm Description
Juven and Centrum Silver 50+ will be administered to this group
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care procedures
Intervention Type
Drug
Intervention Name(s)
Juven
Other Intervention Name(s)
Conditionally essential amino acids
Intervention Description
Nutritional supplements
Intervention Type
Drug
Intervention Name(s)
Centrum Silver 50+
Other Intervention Name(s)
Multivitamin/multimineral
Intervention Description
Over the counter nutritional supplement
Primary Outcome Measure Information:
Title
Assessment of surgical complications at 26 weeks
Description
Number of subjects that experienced any complications post surgery
Time Frame
26 weeks (post surgery)
Secondary Outcome Measure Information:
Title
Hospital Readmissions
Description
Number of hospital re-admissions
Time Frame
26 weeks (post surgery)
Title
Secondary fractures
Description
Number of secondary fractures that occurred post surgery
Time Frame
26 weeks (post surgery)
Title
Grip strength
Description
Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds
Time Frame
Baseline to 26 weeks
Title
Quality of Life Survey (Short-form 36 Health (SF-36))
Description
Change in Health related quality of life (QOL) survey, a 36 item survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
Baseline to 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Male or female, aged 65-89 years
Closed fracture of the proximal femur including the anatomic areas of femoral neck, intertrochanteric and subtrochanteric region
Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per orthopaedic surgeon
Ability to take oral medication and be willing to adhere to the study drug regimen and to the nutritional guidance provided by nutritional experts.
Exclusion Criteria:
Patients with open fractures
Surgical treatment other than surgical fixation or arthroplasty, such as proximal femur resection
Known allergic reactions to components of the study drugs or who do not tolerate oral nutritional supplementation (e.g. total parenteral nutrition or food allergies)
Decisional impairment
Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris Zelle, MD
Phone
210-743-4104
Email
zelle@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Bandfield
Phone
210-450-9096
Email
bandfield@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Zelle, MD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Zelle
Facility Name
UT Health San Antonio Department of Orthopedics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Contact:
Phone
210-216-5439
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected deidentified IPD, that underlie results in a publication
IPD Sharing Time Frame
At the time of publication in a peer reviewed journal
Learn more about this trial
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
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