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

NCT05971173 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HSC20230182H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Fractures

Keywords

Older adults; Hip surgery

Outcome Measures

Primary Outcomes (1)

• Assessment of surgical complications at 26 weeks

  Number of subjects that experienced any complications post surgery

  26 weeks (post surgery)

Secondary Outcomes (4)

• Hospital Readmissions

  26 weeks (post surgery)

• Secondary fractures

  26 weeks (post surgery)

• Grip strength

  Baseline to 26 weeks

• Quality of Life Survey (Short-form 36 Health (SF-36))

  Baseline to 26 weeks

Study Arms (2)

Nutritional Supplements

EXPERIMENTAL

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

Drug: Juven; Drug: Centrum Silver 50+

Control

NO INTERVENTION

Standard of care procedures

Interventions

Juven DRUG

Nutritional supplements

Also known as: Conditionally essential amino acids

Nutritional Supplements

Centrum Silver 50+ DRUG

Over the counter nutritional supplement

Also known as: Multivitamin/multimineral

Nutritional Supplements

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (2)

University Health System

San Antonio, Texas, 78229, United States

Location

UT Health San Antonio Department of Orthopedics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Geritol

Condition Hierarchy (Ancestors)

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

Study Officials

• Boris Zelle, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 2, 2023
• Study Start: September 28, 2023
• Primary Completion: December 10, 2024
• Study Completion: June 4, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the time of publication in a peer reviewed journal

Locations

US (2)