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NCT Number: NCT05971173

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

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.

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Key information

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UT Health San Antonio Department of Orthopedics, San Antonio, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Juven

Drug

Nutritional supplements

Other names: Conditionally essential amino acids

Centrum Silver 50+

Drug

Over the counter nutritional supplement

Other names: Multivitamin/multimineral

Primary outcomes

  1. Assessment of surgical complications at 26 weeks

    Time frame: 26 weeks (post surgery)

    Number of subjects that experienced any complications post surgery

Secondary outcomes

  1. Hospital Readmissions

    Time frame: 26 weeks (post surgery)

    Number of hospital re-admissions

  2. Secondary fractures

    Time frame: 26 weeks (post surgery)

    Number of secondary fractures that occurred post surgery

  3. Grip strength

    Time frame: Baseline to 26 weeks

    Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds

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

    Time frame: Baseline to 26 weeks

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 2, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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