Condition category
Musculoskeletal Diseases
Date applied
13/07/2016
Date assigned
21/07/2016
Last edited
21/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 attend 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

Trial website

Contact information

Type

Public

Primary contact

Dr Emmanuel Biver

ORCID ID

Contact details

Division of Bone Diseases
Geneva University Hospitals and Faculty of Medicine
4 Rue Gabrielle Perret-Gentil
Geneva 14
1211
Switzerland

Additional identifiers

EudraCT 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

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

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below 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

Not Specified

Phase

Drug names

Primary outcome measures

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 trial start date

12/02/2008

Overall trial end date

31/12/2018

Reason abandoned

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

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

1036

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

Trial 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

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

We 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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

1. Hars M, Biver E, Chevalley T, Herrmann F, Rizzoli R, Ferrari S, Trombetti A. Low Lean Mass Predicts Incident Fractures Independently From FRAX: a Prospective Cohort Study of Recent Retirees. J Bone Miner Res. 2016 Jun 2. doi: 10.1002/jbmr.2878.
2. Biver E, Durosier C, Chevalley T, Herrmann FR, Ferrari S, Rizzoli R. Prior ankle fractures in postmenopausal women are associated with low areal bone mineral density and bone microstructure alterations. Osteoporos Int. 2015 Aug;26(8):2147-55.
3. Durosier C, van Lierop A, Ferrari S, Chevalley T, Papapoulos S, Rizzoli R. Association of circulating sclerostin with bone mineral mass, microstructure, and turnover biochemical markers in healthy elderly men and women. J Clin Endocrinol Metab. 2013 Sep;98(9):3873-83.

Publication citations

Additional files

Editorial Notes