Plain English Summary
Background and study aims
Musculoskeletal aging, leading to osteoporosis (a health condition where the bone becomes brittle and fragile) and sarcopenia (a condition where muscle loses its mass – so it shrinks – and strength) , results in falls and fractures that largely contribute to mortality (disease and ill-health) and loss of quality of life in the elderly. In order to provide a more complete understanding of bone and muscle aging and a rationale for targeted interventions (treatments) to prevent falls and osteoporotic (bone)fractures, this study aims at identifying the intrinsic and extrinsic determinants of musculo-skeletal aging, and their contribution to quality of life.
Who can participate?
1036 retired community-dwelling healthy volunteers (men and women) from the Geneva area, at the age of 63-67 (Geneva Retirees Cohort (GERICO)).
What does the study involve?
Each participant in the study attends a study visit every three years to assess their current state of bone and muscle health. These are determined by measuring bone mineral density (measuring the amount of minerals in the bone) and the architecture of the bone (structure), muscle mass, how the muscles function and physical performance. Medical conditions are also noted, as are the number of fractures and falls, the participants nutrient intake and how physically active they are.
What are the possible benefits and risks of participating?
Participant will benefit from a comprehensive assessment of their bone and muscle health. No specific risk is expected.
Where is the study run from?
Service of Bone diseases, University Hospitals of Geneva (Switzerland)
When is study starting and how long is it expected to run for?
February 2008 to December 2018
Who is funding the study?
Geneva University Hospitals and Faculty of Medicine Clinical Research Centre (Switzerland)
Who is the main contact?
Dr Emmanuel Biver
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Musculoskeletal aging in the Geneva Retirees Cohort (GERICO): a prospective analysis of its determinants and contribution to fractures and quality of life
Acronym
GERICO (Geneva Retirees Cohort)
Study hypothesis
Predictors of falls and fractures, two major outcomes of osteoporosis and sarcopenia contributing to age-related disabilities and quality of life alterations, would be identifiable at time of retirement.
Ethics approval(s)
1. Central Ethics Committee on Research on human beings of Geneva University Hospitals, 17/08/2008, ref: 08-036 (Psy 08-007)
2. Central Ethics Committee on Research on human beings of Geneva University Hospitals, 04/05/2012, ref: 11-256 (Psy 11-031)
3. Geneva Cantonal Committee of Research Ethics, 08/07/2015, ref: CER 15-133
Study design
Prospective single-center observational cohort study
Primary study design
Observational
Secondary study design
Longitudinal study
Study setting(s)
Community
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Musculoskeletal diseases
Intervention
The Geneva Retirees Cohort (GERICO) is a prospective observational cohort study of community-dwelling women and men recruited between 2008 and 2011 at the age of 65±1.4 yrs and followed longitudinally every 3 years after their first visit to assess the determinants of bone and muscle health alterations with aging. A second visit (follow-up 1) was initiated in 2012 and completed in 2014, and a third visit (follow-up 2) is undergoing since August 2015 until 2018.
Participants are assessed at each visit for:
1. Medical conditions, fractures and falls history, nutrition, physical activity.
2. Bone mineral density and micro-architecture
3. Muscle mass and function and physical performance (from second visit)
4. Blood tests
Intervention type
Other
Primary outcome measure
Incident fractures, assessed by face-to-face or and auto-administered questionnaires (clinical fractures) and vertebral fracture assessment (VFA) by DXA (morphometric vertebral fractures) at follow-up 1 (after 3 years) and 2 (after 6 years). Written confirmation (eg, discharge summary, radiologist report) will be requested.
Secondary outcome measures
1. Bone phenotype at baseline, follow-up 1 (after 3 years) and 2 (after 6 years)
1.1. Bone mineral density using DXA (lumbar spine, hip, radius)
1.2. Bone microstructure and strength using high resolution peripheral computerized tomography (HR-pQCT) at distal radius and tibia
2. Muscle phenotype at follow-up 1 and 2
2.1. Muscle mass and appendicular lean mass adjusted for height mass (kg/m2) using DXA.
2.2. Muscle function and physical performance
3. Falls in the past years of follow-up 1 and 2
4. Genotyping at baseline using exome chip
5. Biochemical measurements of bone and mineral metabolism at baseline, follow-up 1 and 2.
6. Nutrition (calcium and protein intakes) using a food frequency questionnaire at baseline, follow-up 1 and 2
7. Physical activity using a face-to-face administered questionnaire at baseline, follow-up 1 and 2
8. Ten-year fracture probability using FRAX tool at baseline, follow-up 1 and 2
9. Assessment of quality of life using auto-administered questionnaires at follow-up 2
Overall study start date
12/02/2008
Overall study end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Recently retired workers from the Geneva area
2. Both genders
3. Age 63 to 67 years
4. Rural and urban communities
Participant type(s)
Healthy volunteer
Age group
Senior
Sex
Both
Target number of participants
1036
Total final enrolment
853
Participant exclusion criteria
1. History of cancer treated in the past 5 years
2. Chronic renal failure
3. Chronic liver or lung disease
4. Current corticosteroid therapy
5. Primary hyperparathyroidism
6. Paget disease of bone
7. Malabsorption
8. Any neurological or musculoskeletal condition affecting skeletal health
Recruitment start date
22/07/2008
Recruitment end date
15/10/2014
Locations
Countries of recruitment
Switzerland
Study participating centre
Service of Bone Diseases, Department of Internal Medicine Specialties, Geneva University Hospital
4 Rue Gabrielle Perret-Gentil
Geneva 14
1211
Switzerland
Sponsor information
Organisation
Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine
Sponsor details
4
Rue Gabrielle Perret-Gentil
Geneva 14
1211
Switzerland
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Geneva University Hospitals and Faculty of Medicine Clinical Research Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists intend to present preliminary study results at scientific conferences during the course of the study and plan publications in high-impact peer reviewed journals around one year after the end of follow-up.
Intention to publish date
31/12/2019
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No | |
| Results article | results | 01/11/2016 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2018 | Yes | No | |
| Results article | results | 01/08/2018 | Yes | No | |
| Results article | results | 01/10/2020 | 20/07/2020 | Yes | No |
| Other publications | Development of a personalized fall rate prediction model | 30/03/2023 | 31/03/2023 | Yes | No |