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

NCT ID: NCT05971173

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-28
• Study Completion Date: 2025-06-04

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nutritional Supplements

Juven and Centrum Silver 50+ will be administered to this group

Group Type: EXPERIMENTAL

Juven

Intervention Type: DRUG

Nutritional supplements

Centrum Silver 50+

Intervention Type: DRUG

Over the counter nutritional supplement

Control

Standard of care procedures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Juven

Nutritional supplements

Intervention Type: DRUG

Centrum Silver 50+

Over the counter nutritional supplement

Intervention Type: DRUG

Other Intervention Names

Conditionally essential amino acids; Multivitamin/multimineral

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boris Zelle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

University Health System

San Antonio, Texas, United States

UT Health San Antonio Department of Orthopedics

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20230182H

Identifier Type: -

Identifier Source: org_study_id