Musculoskeletal aging in the Geneva Retirees Cohort
| ISRCTN | ISRCTN11865958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11865958 |
| Protocol serial number | N/A |
| Sponsor | Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine |
| Funder | Geneva University Hospitals and Faculty of Medicine Clinical Research Centre |
- Submission date
- 13/07/2016
- Registration date
- 21/07/2016
- Last edited
- 05/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine
4 Rue Gabrielle Perret-Gentil
Geneva 14
1211
Switzerland
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective single-center observational cohort study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Musculoskeletal aging in the Geneva Retirees Cohort (GERICO): a prospective analysis of its determinants and contribution to fractures and quality of life |
| Study acronym | GERICO (Geneva Retirees Cohort) |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Bone phenotype at baseline, follow-up 1 (after 3 years) and 2 (after 6 years) |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 63 Years |
| Upper age limit | 67 Years |
| Sex | All |
| Target sample size at registration | 1036 |
| Total final enrolment | 853 |
| Key inclusion criteria | 1. Recently retired workers from the Geneva area 2. Both genders 3. Age 63 to 67 years 4. Rural and urban communities |
| Key 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 |
| Date of first enrolment | 22/07/2008 |
| Date of final enrolment | 15/10/2014 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Geneva 14
1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2013 | Yes | No | ||
| Results article | 01/08/2015 | Yes | No | ||
| Results article | 01/11/2016 | Yes | No | ||
| Results article | 01/02/2017 | Yes | No | ||
| Results article | 01/02/2018 | Yes | No | ||
| Results article | 01/08/2018 | Yes | No | ||
| Results article | 01/10/2020 | 20/07/2020 | Yes | No | |
| Results article | 21/03/2022 | 05/08/2024 | Yes | No | |
| Other publications | Development of a personalized fall rate prediction model | 30/03/2023 | 31/03/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/08/2024: Publication reference added.
31/03/2023: Publication reference added.
20/07/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
08/05/2018: Publication reference added.
20/10/2017: Publication reference added.
02/10/2017: Publication reference added.
