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

Hip Fractures Clinical Trial

Official title:

Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971173
• Other study ID #: HSC20230182H
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 28, 2023
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Boris Zelle, MD
• Phone: 210-743-4104
• Email: zelle[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Juven
Nutritional supplements
• Centrum Silver 50+
Over the counter nutritional supplement

Locations

Country	Name	City	State
United States	University Health System	San Antonio	Texas
United States	UT Health San Antonio Department of Orthopedics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of surgical complications at 26 weeks	Number of subjects that experienced any complications post surgery	26 weeks (post surgery)
Secondary	Hospital Readmissions	Number of hospital re-admissions	26 weeks (post surgery)
Secondary	Secondary fractures	Number of secondary fractures that occurred post surgery	26 weeks (post surgery)
Secondary	Grip strength	Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds	Baseline to 26 weeks
Secondary	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.	Baseline to 26 weeks