Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05971173
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 18.1
• Patients Per Site: 20
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures	Drug: Juven; Drug: Centrum Silver 50+	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nutritional Supplements Juven and Centrum Silver 50+ will be administered to this group	Drug: Juven; Nutritional supplements; Other Names: Conditionally essential amino acids ; Drug: Centrum Silver 50+; Over the counter nutritional supplement; Other Names: Multivitamin/multimineral
No Intervention: Control Standard of care procedures

Outcome Measures

Primary Outcome Measures

1. Assessment of surgical complications at 26 weeks [26 weeks (post surgery)]

   Number of subjects that experienced any complications post surgery

Secondary Outcome Measures

1. Hospital Readmissions [26 weeks (post surgery)]

   Number of hospital re-admissions

2. Secondary fractures [26 weeks (post surgery)]

   Number of secondary fractures that occurred post surgery

3. Grip strength [Baseline to 26 weeks]

   Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds

4. Quality of Life Survey (Short-form 36 Health (SF-36)) [Baseline to 26 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Male or female, aged 65-89 years

3. Closed fracture of the proximal femur including the anatomic areas of femoral neck, intertrochanteric and subtrochanteric region

4. Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per orthopaedic surgeon

5. 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:

1. Patients with open fractures

2. Surgical treatment other than surgical fixation or arthroplasty, such as proximal femur resection

3. 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)

4. Decisional impairment

5. Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health System	San Antonio	Texas	United States	78229
2	UT Health San Antonio Department of Orthopedics	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Boris Zelle, MD, University of Texas Health Science Center San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boris Zelle, Vice Chair of Research, Chief of Orthopaedic Trauma, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT05971173
• Other Study ID Numbers: HSC20230182H; 5P30AG044271
• First Posted: Aug 2, 2023
• Last Update Posted: Aug 2, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Boris Zelle, Vice Chair of Research, Chief of Orthopaedic Trauma, The University of Texas Health Science Center at San Antonio: Older adults; Hip surgery
• Additional relevant MeSH terms: Fractures, Bone; Hip Fractures

Study Results

No Results Posted as of Aug 2, 2023