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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Hip Fractures

Treatments: Drug: Juven; Drug: Centrum Silver 50+

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05971173

HSC20230182H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 65 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Nutritional Supplements

Experimental group

Description:

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

Treatment:

Drug: Centrum Silver 50+

Drug: Juven

Control

No Intervention group

Description:

Standard of care procedures