Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Aldo Bertoli
ORCID ID
http://orcid.org/0000-0001-8995-2582
Contact details
Viale Oxford 81
Roma
I-00133
Italy
Type
Scientific
Additional contact
Dr Massimo Federici
ORCID ID
Contact details
Dpt of Systems Medicine
University of Rome Tor Vergata
Via Montpellier 1
Rome
I-00123
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Ethical Committe "Tor Vergata" Protocol n. 72/14, 29/04/2014
Study information
Scientific title
Aging of the endocrine system and clinical outcome of frail elderly patients with fractures: an observational study
Acronym
Study hypothesis
To evaluate the role of endocrine system aging in the clinical outcome of elderly patients with low energy fracture.
Ethics approval
Comitato Etico Indipendente, Fondazione PTV Policlinico Tor Vergata (Ethical Committee of the Polyclinic Tor Vergata), 04/06/2014, ref: 72/14
Study design
Cross-sectional case-control observational study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/01/2014
Overall trial end date
12/12/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
200
Participant exclusion criteria
Presence of a malignancy or a history of previous cancer
Recruitment start date
01/05/2014
Recruitment end date
31/12/2017
Locations
Countries of recruitment
Italy
Trial participating centre
Polyclinic of Rome, "Tor Vergata"
Viale Oxford, 81
Rome
I-00133
Italy
Sponsor information
Organisation
University of Rome "Tor Vergata"
Sponsor details
Via Montpellier 1
Rome
I-00133
Italy
+39 (0)6 2090 3618
aldo.bertoli@uniroma2.it
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Università degli Studi di Roma Tor Vergata
Alternative name(s)
University of Rome Tor Vergata
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Italy
Results and Publications
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.
Intention to publish date
01/02/2017
Participant level data
Stored in repository
Results - basic reporting
Publication summary