Contact information
Type
Scientific
Primary contact
Dr Geeta Hampson
ORCID ID
Contact details
Senior Lecturer
Department of Chemical Pathology
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7928 9292 ext 2881
geeta.hampson@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP0714
Study information
Scientific title
A randomised controlled trial of combination therapy using calcium/vitamin D and protein/calorie supplements in nutritionally deficient women: an assessment of changes in osteoporotic fracture risk
Acronym
Study hypothesis
To investigate the effects of dietary advice and nutritional supplementation on bone mineral density.
Ethics approval
The Research Ethics Committee of the Guys and St Thomas Hospital NHS Trust gave approval
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Osteoporosis
Intervention
Women meeting the entry criteria will be randomised to one of two groups:
1. A control group will receive calcium/vitamin D only
2. The second group will receive dietary advice and nutritional supplements to increase their dietary intake and calcium/vitamin D
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Body composition and bone mineral density (BMD), assessed at baseline and 12 months.
Secondary outcome measures
Biochemical markers of bone turnover, measured at baseline and at 1, 3, 6, 9 and 12 months.
Overall trial start date
01/09/1999
Overall trial end date
31/08/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women over 70 years
2. Body mass index of less than 21 kg/m^2
3. Osteoporosis at the femoral neck and/or total hip
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
71
Participant exclusion criteria
1. Evidence of any progressive wasting disease, e.g. carcinomatosis, severe malabsorption
2. Severe renal impairment (estimated glomerular filtration rate [GFR] less than or equal to 45 ml/min)
3. Severe cardiorespiratory diseases
4. Endocrine diseases, e.g., hyperparathyroidism, hyperthyroidism
5. Therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, oestrogen, raloxifene
6. Cognitive impairment (abbreviated mental test score 7 or below)
Recruitment start date
01/09/1999
Recruitment end date
31/08/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Senior Lecturer
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12904840
Publication citations
-
Results
Hampson G, Martin FC, Moffat K, Vaja S, Sankaralingam S, Cheung J, Blake GM, Fogelman I, Effects of dietary improvement on bone metabolism in elderly underweight women with osteoporosis: a randomised controlled trial., Osteoporos Int, 2003, 14, 9, 750-756, doi: 10.1007/s00198-003-1440-1.