Condition category
Not Applicable
Date applied
13/02/2017
Date assigned
25/04/2017
Last edited
25/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes