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

Last updated: March 14, 2025
Sponsor: The University of Texas Health Science Center at San Antonio
Overall Status: Active - Not Recruiting

Phase

1

Condition

Osteoporosis

Treatment

Juven

Centrum Silver 50+

Clinical Study ID

NCT05971173
HSC20230182H
5P30AG044271
  • Ages 65-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 perorthopaedic surgeon

  5. Ability to take oral medication and be willing to adhere to the study drug regimenand to the nutritional guidance provided by nutritional experts.

Exclusion

Exclusion Criteria:

  1. Patients with open fractures

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

  3. Known allergic reactions to components of the study drugs or who do not tolerateoral nutritional supplementation (e.g. total parenteral nutrition or food allergies)

  4. Decisional impairment

  5. Prisoners

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Juven
Phase: 1
Study Start date:
September 28, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • UT Health San Antonio Department of Orthopedics

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University Health System

    San Antonio, Texas 78229
    United States

    Site Not Available

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