Gambian bone and muscle ageing study

ISRCTN	ISRCTN17900679
DOI	https://doi.org/10.1186/ISRCTN17900679
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	N/A
Sponsor	Medical Research Council
Funder	Medical Research Council

Submission date: 09/06/2017
Registration date: 17/06/2019
Last edited: 03/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 2023

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Kate Ward

Contact information

Dr Kate Ward
Scientific

MRC Lifecourse Epidemiology
University of Southampton
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

ORCID ID	0000-0001-7034-6750
Phone	+44 (0)2380 777624
Email	kw@mrc.soton.ac.uk

Study information

Primary study design	Observational
Study design	Prospective longitudinal observational study
Secondary study design	Longitudinal study
Study type	Participant information sheet
Scientific title	Gambian Bone and Muscle Ageing Study (GamBAS): a longitudinal observational study in men and women in rural Gambia
Study acronym	GamBAS
Study objectives	To characterise changes in bone and muscle outcomes and to identify possible preventative strategies for fracture and sarcopenia.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Lower age limit	40 Years
Sex	All
Target sample size at registration	480
Total final enrolment	488
Key inclusion criteria	1. Men and women aged 40 years and above 2. Able to give informed consent
Key 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
Date of first enrolment	17/10/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Gambia

Study participating centre

Kiang West, Lower River Division

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Gambia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Sex-specific associations between cardiovascular risk factors and physical function	08/11/2022	03/07/2025	Yes	No
Results article	Vertebral fracture prevalence and risk factors for fracture	07/11/2024	03/07/2025	Yes	No
Abstract results		26/10/2021	03/07/2025	No	No
Other publications	baseline data	31/08/2017	11/06/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/07/2025: Publication references added.
21/01/2022: The following changes have been made:
1. The study contacts were updated.
2. The overall trial end date has been changed from 31/12/2020 to 31/12/2023.
3. The plain English summary has been updated to reflect the changes above.
18/01/2022: The contacts were updated.
11/06/2019: Trial's existence confirmed by the Medical Research Council/Gambian Government Joint Ethics Committee.