Aging of the endocrine system and clinical outcome of frail elderly patients with fractures
| ISRCTN | ISRCTN17358246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17358246 |
| Protocol serial number | Ethical Committe "Tor Vergata" Protocol n. 72/14, 29/04/2014 |
| Sponsor | University of Rome "Tor Vergata" |
| Funder | Università degli Studi di Roma Tor Vergata |
- Submission date
- 13/02/2017
- Registration date
- 25/04/2017
- Last edited
- 05/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Hip fractures are cracks or breaks in the top of the thigh bone close to the hip joint, usually caused by a fall or an injury. They are a severe complication in frail elderly patients. The aim of this study is to assess endocrine (hormone) system changes in elderly frail patients and their relationship with frailty.
Who can participate?
Patients aged over 65 who have been hospitalised following hip fracture, and outpatients without hip fracture
What does the study involve?
Participants’ weight and height are measured and their medical history is recorded, including drugs taken chronically (long-term). Participants undergo an extensive clinical evaluation to assess their degree of frailty, and undergo a physical examination and blood sampling for laboratory tests of hormone levels.
What are the possible benefits and risks of participating?
Participants benefit from an extensive clinical evaluation and follow-up. No risks are expected.
Where is the study run from?
University Hospital "Tor Vergata" (Italy)
When is the study starting and how long is it expected to run for?
January 2014 to December 2017
Who is funding the study?
University of Rome "Tor Vergata" (Italy)
Who is the main contact?
Dr Aldo Bertoli
Contact information
Scientific
Viale Oxford 81
Roma
I-00133
Italy
 ORCID ID |
0000-0001-8995-2582 |
|---|
Scientific
Dpt of Systems Medicine
University of Rome Tor Vergata
Via Montpellier 1
Rome
I-00123
Italy
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cross-sectional case-control observational study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Aging of the endocrine system and clinical outcome of frail elderly patients with fractures: an observational study |
| Study objectives | To evaluate the role of endocrine system aging in the clinical outcome of elderly patients with low energy fracture. |
| Ethics approval(s) | Comitato Etico Indipendente, Fondazione PTV Policlinico Tor Vergata (Ethical Committee of the Polyclinic Tor Vergata), 04/06/2014, ref: 72/14 |
| Health condition(s) or problem(s) studied | Aging and frailty |
| Intervention | The study was aimed to evaluate the prevalence of endocrine system modifications in elderly frail subjects and its relationship with frailty. Subjects with hip fracture and outpatients without fracture were evaluated. Each patient’s sex and age were recorded, anthropometric parameters were measured (weight and height), and the body mass index (BMI) was calculated. The medical history of each patient was recorded, including drugs taken chronically. Participating patients received a multidimensional geriatric evaluation comprising the following scales: Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL); Mini–Mental State Examination (MMSE); Geriatric Depression Scale (GDS); and Mini Nutritional Assessment (MNA). Frailty was measured using SHARE-FI and major osteoporotic and hip risk measured by FRAX Score tool. Comorbidities were assessed using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G), from which we obtained the CIRS severity (CIRS-S), CIRS comorbidity index (CIRS-CI), and Charlson comorbidity index (CCI). All study participants underwent physical examination and blood sampling for laboratory assays (blood count, creatinine, glucose, albumin, electrolytes, serum cortisol, TSH, free T3 [FT3], free T4 [FT4], IGF-1, GH, DHEAS, PTH, Vitamin D, OPG, OC, high-sensitivity C-reactive protein [hs-CRP], interleukin-6 [IL-6] and tumor necrosis factor-α [TNF-α]). Serum, plasma and DNA samples are stored at -80 °C for further eventual examinations. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Prevalence of endocrine system abnormalities, measured using blood sampling for laboratory assays at baseline (serum cortisol, TSH, free T3 [FT3], free T4 [FT4], IGF-1, GH, DHEAS, PTH, Vitamin D, OPG, OC, interleukin-6 [IL-6] and tumor necrosis factor-α [TNF-α]) |
| Key secondary outcome measure(s) |
1. Disability, measured using ADL (Activities of Daily Living) and IADL (Instrumental Activities of Daily Living) at baseline and 1 and 2 years follow-up |
| Completion date | 12/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 112 |
| Key inclusion criteria | 1. Patients hospitalized in the Orthopedic Department after a hip fracture 2. Control subjects enrolled among outpatients evaluated at the Department of Medicine (Clinical Program on Atherosclerosis) 3. Age over 65 years |
| Key exclusion criteria | Presence of a malignancy or a history of previous cancer |
| Date of first enrolment | 01/05/2014 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
I-00133
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The dataset generated during an/or analysed during the current study will be stored in non-publically available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/02/2017 | 05/10/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/10/2022: Publication reference and total final enrolment added.
