Aging of the endocrine system and clinical outcome of frail elderly patients with fractures

ISRCTN	ISRCTN17358246
DOI	https://doi.org/10.1186/ISRCTN17358246
Secondary identifying numbers	Ethical Committe "Tor Vergata" Protocol n. 72/14, 29/04/2014

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Aldo Bertoli
Scientific

Viale Oxford 81
Roma
I-00133
Italy

ORCID ID	0000-0001-8995-2582

Dr Massimo Federici
Scientific

Dpt of Systems Medicine
University of Rome Tor Vergata
Via Montpellier 1
Rome
I-00123
Italy

Study information

Study design	Cross-sectional case-control observational study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Other
Participant information sheet	No participant information sheet available
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	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])
Secondary outcome measures	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 2. Cognitive impairment, measured using Mini-Mental State Examination (MMSE) at baseline 3. Nutritional status, measured using Mini Nutritional Assesment (MNA) at baseline and 1 and 2 years follow-up 4. Comorbidities, assessed using Cumulative Illness Rating Scale for Geriatrics (CIRS-G) and Charlson comorbidity index (CCI) at baseline 5. Frailty, measured by SHARE-FI at baseline 6. Major osteoporotic and hip risk, measured by FRAX Score tool at baseline 7. Mortality and recurrence of fracture, measured at 1 and 2 years follow-up
Overall study start date	01/01/2014
Completion date	12/12/2017

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	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

Polyclinic of Rome, "Tor Vergata"

Viale Oxford, 81
Rome
I-00133
Italy

Sponsor information

University of Rome "Tor Vergata"
University/education

Via Montpellier 1
Rome
I-00133
Italy

Phone	+39 (0)6 2090 3618
Email	aldo.bertoli@uniroma2.it
"ROR"	https://ror.org/02p77k626

Funders

Funder type

University/education

Università degli Studi di Roma Tor Vergata
Private sector organisation / Universities (academic only)

Alternative name(s): University of Rome Tor Vergata
Location: Italy

Results and Publications

Intention to publish date	01/02/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal. The intention is to publish first data in February 2017.
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

Editorial Notes

05/10/2022: Publication reference and total final enrolment added.