Hip FracturesEarly Phase 1NCT05971173
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
A Early Phase 1 study testing Juven and Centrum Silver 50+ in people with Hip Fractures, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Juven and Centrum Silver 50+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2023to 4 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Health System
San Antonio, Texas, 78229
UT Health San Antonio Department of Orthopedics
San Antonio, Texas, 78229
About this study
Official title: Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study
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.
Read the detailed 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.
- Conditions
- Hip Fractures
- Being tested
- Juven, Centrum Silver 50+
- Keywords
- Older adults, Hip surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuvenDrug
Also called Conditionally essential amino acids
Nutritional supplements
Centrum Silver 50+Drug
Also called Multivitamin/multimineral
Over the counter nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplements | Experimental | Juven and Centrum Silver 50+ will be administered to this group Receives: Drug: Juven; Drug: Centrum Silver 50+ |
| Control | No intervention | Standard of care procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of surgical complications at 26 weeks
Number of subjects that experienced any complications post surgery
Measured: 26 weeks (post surgery)
Secondary outcomes (4)
Hospital Readmissions
Number of hospital re-admissions
Measured: 26 weeks (post surgery)
Secondary fractures
Number of secondary fractures that occurred post surgery
Measured: 26 weeks (post surgery)
Grip strength
Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds
Measured: Baseline to 26 weeks
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.
Measured: Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start28 Sep 2023
- Primary completion10 Dec 2024
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Zelle, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971173
- Sponsor's protocol ID
- HSC20230182H
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected deidentified IPD, that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT05971173
- Acronym / sponsor ID
- HSC20230182H
- Conditions
- Hip Fractures
- Keywords
- Older adults, Hip surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplements | Experimental | Drug: Juven, Drug: Centrum Silver 50+Juven and Centrum Silver 50+ will be administered to this group |
| Control | No intervention | –Standard of care procedures |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JuvenAlso: Conditionally essential amino acidsNutritional supplements | Drug | Nutritional Supplements |
| Centrum Silver 50+Also: Multivitamin/multimineralOver the counter nutritional supplement | Drug | Nutritional Supplements |
Primary outcome
Assessment of surgical complications at 26 weeks
Time frame: 26 weeks (post surgery)
Number of subjects that experienced any complications post surgery
4 secondary outcomes
Hospital Readmissions
Time frame: 26 weeks (post surgery)
Secondary fractures
Time frame: 26 weeks (post surgery)
Grip strength
Time frame: Baseline to 26 weeks
Quality of Life Survey (Short-form 36 Health (SF-36))
Time frame: Baseline to 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. All collected deidentified IPD, that underlie results in a publication
Related trials for Hip Fractures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Zelle, MD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Juven and Centrum Silver 50+ in people with Hip Fractures, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of surgical complications at 26 weeks (time frame: 26 weeks (post surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.