Condition category
Musculoskeletal Diseases
Date applied
09/06/2017
Date assigned
17/06/2019
Last edited
14/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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)

Publication citations

Additional files

Editorial Notes

11/06/2019: Trial's existence confirmed by the Medical Research Council/Gambian Government Joint Ethics Committee.