Plain English Summary
Background and study aims
Musculoskeletal diseases are diseases of the bones, muscles and their attachments (e.g. joints and ligaments). They form a major part of the current global non-communicable (not caused by infections) disease burden. By 2050, the vast majority of the world’s ageing population will live in low- and middle-income countries. There is very little information about musculoskeletal diseases from countries in sub-Sarahan Africa. This study is investigating men and women from a poor, subsistence farming community of The Gambia, West Africa. The study is designed to measure changes in bone and muscle health using state of the art techniques and identify possible ways of preventing bone and muscle loss as people get older, and the accompanying risk of falls and fractures which lead to poor health, disability and premature deaths.
Who can participate?
Men and women aged 40 and over living in villages in the Kiang West area of The Gambia
What does the study involve?
Participants are invited to undergo measurements both in the MRC research facilities in The Gambia and whilst they are at home. After measurements have been made at the start of the study they are then seen every 1.5-2 years for follow-up measurements. The data collected includes measurements of bone and muscle strength, hormones and metabolites in urine and blood samples, dietary intake, and blood pressure. Questionnaires are used to obtain information on health, lifestyle, musculoskeletal pain, socioeconomic status, physical activity and reproductive history.
What are the possible benefits and risks of participating?
There are no direct benefits to the participants, other than participation in research aimed at improving health and informing public health nutrition policy in The Gambia and other countries. Participants who have results which may be clinically relevant and suggest previously undiagnosed health problems are referred to the study physician or nurse for initial follow up and then decisions are taken as to whether treatment or further investigation is needed. Ultimately, the findings from this study will contribute to the understanding of musculoskeletal health in populations transitioning from traditional to more western lifestyles. The results are also compared with those obtained from studies of older people in the UK.
Where is the study run from?
The study is being run by the Medical Research Council and takes place in rural villages in The Gambia, West Africa
When is the study starting and how long is it expected to run for?
April 2010 to December 2020
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
1. Kate Ward
2. Ann Prentice
3. Gail Goldberg
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kate Ward
ORCID ID
http://orcid.org/0000-0001-7034-6750
Contact details
MRC Lifecourse Epidemiology
University of Southampton
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 777624
kw@mrc.soton.ac.uk
Type
Scientific
Additional contact
Dr Ann Prentice
ORCID ID
http://orcid.org/0000-0003-0254-6659
Contact details
MRC Nutrition and Bone Health Research Group
Clifford Allbutt Building
University of Cambridge
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0AH
United Kingdom
+44 (0)1223 763381
ann.prentice@mrc-lmb.cam.ac.uk
Type
Scientific
Additional contact
Dr Gail Goldberg
ORCID ID
http://orcid.org/0000-0001-5927-7539
Contact details
MRC Nutrition and Bone Health Research Group
Clifford Allbutt Building
University of Cambridge
Cambridge Biomedical Campus
Hills Road
Cambridge
CB1 9NL
United Kingdom
+44 (0)1223 763393
gail.goldberg@mrc-lmb.cam.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
N/A
Study information
Scientific title
Gambian Bone and Muscle Ageing Study (GamBAS): a longitudinal observational study in men and women in rural Gambia
Acronym
GamBAS
Study hypothesis
To characterise changes in bone and muscle outcomes and to identify possible preventative strategies for fracture and sarcopenia.
Ethics approval
Approved 17/12/2010, Medical Research Council/Gambian Government Joint Ethics Committee (Clo MRC Laboratories, Fajara, P.0. Box 273, Banjul, The Gambia, West Africa; +220-4495919 or 4496 513; +220-4495442-6 ext. 2308), ref: 1222.
Study design
Prospective longitudinal observational study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Community
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Musculoskeletal health
Intervention
Measurements are made at baseline and follow-up every 1.5-2 years.
Methods include bone imaging (DXA and pQCT), muscle strength (jumping mechanography, grip strength), anthropometry, blood and urine biochemistry, blood pressure, and dietary intake. Questionnaires to obtain information on health, lifestyle, physical activity, socio-economic status, musculoskeletal pain, reproductive history.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Bone mineral content (BMC) is measured using DXA measurements at baseline and follow-ups.
2. Areal bone mineral density (BMD) is measured using DXA at baseline and follow-ups.
3. Bone area is measured using DXA at baseline and follow-ups.
4. BMC is measured using peripheral quantitative CT (pQCT) at baseline and follow-ups.
5. Volumetric BMD is measured using pQCT at baseline and follow-ups.
Secondary outcome measures
1. Bone shape and size by DXA and pQCT.
2. Muscle force/ strength Hand dynamometry for grip force: muscle force/ strength
3. Lateral vertebral assessment using DXA at baseline and follow-ups.
4. Regional and total fat and lean mass are measured using DXA at baseline and follow-ups.
5. Muscle ‘density’ and area are measured using pQCT at baseline and follow-ups.
6. Height (standing and sitting), demi-span and other limb dimensions, weight, mid-upper arm circumference (MUAC) and 4 skinfolds are measured at baseline and follow-ups.
7. Standing, sitting and lying blood pressure is measured at baseline and follow-ups.
8. Fasting blood, 2-h fasting urine, 24-h urine: including for markers of calcium, phosphate and vitamin D metabolism, bone metabolism, liver and kidney function, clinical chemistry, sex hormones are measured at baseline and follow-ups.
9. Dietary assessment is conducted at baseline and follow-ups.
Overall trial start date
01/04/2010
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women aged 40 and above
2. Able to give informed consent
Participant type
Healthy volunteer
Age group
Mixed
Gender
Both
Target number of participants
Stratified sampling to ensure recruitment of equal numbers of men and women in each of eight, 5-year age bands: 40-44, 45-49, 50-54, 55-59, 60-64, 65-69, 70-74, 75 years and over; 240 women and 240 men, totalling 480 participants.
Total final enrolment
488
Participant exclusion criteria
1. Pregnant or lactating women
2. Individuals deemed too physically frail or incapable, due to existing disability or chronic illness to attend for measurements
Recruitment start date
17/10/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Gambia
Trial participating centre
Kiang West, Lower River Division
-
Gambia
Sponsor information
Organisation
Medical Research Council
Sponsor details
14th Floor
One Kemble Street
London
WC2B 4AN
United Kingdom
+44 (0)1793 416 200
corporate@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Papers from baseline and first follow up are in preparation.
IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
31/12/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
1. 2017 baseline data in: https://www.ncbi.nlm.nih.gov/pubmed/28912754 (added 11/06/2019)