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ISRCTN
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ISRCTN62937696
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DOI
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10.1186/ISRCTN62937696
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Combination therapy using calcium/vitamin D and protein/calorie supplements in nutritionally deficient women
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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AP0714
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Study hypothesis
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To investigate the effects of dietary advice and nutritional supplementation on bone mineral density.
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Lay summary
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Ethics approval
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The Research Ethics Committee of the Guy’s and St Thomas’ Hospital NHS Trust gave approval
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Osteoporosis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/09/1999
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Anticipated end date
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31/08/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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71
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Interventions
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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
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Primary outcome measure(s)
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Body composition and bone mineral density (BMD), assessed at baseline and 12 months.
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Secondary outcome measure(s)
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Biochemical markers of bone turnover, measured at baseline and at 1, 3, 6, 9 and 12 months.
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Sources of funding
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Action Medical Research (UK)
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Trial website
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Publications
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2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12904840
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Contact name
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Dr
Geeta
Hampson
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Address
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Senior Lecturer
Department of Chemical Pathology
St Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7928 9292 ext 2881
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Email
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geeta.hampson@kcl.ac.uk
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Sponsor
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Action Medical Research (UK)
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Address
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Vincent House
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City/town
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Horsham West Sussex
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Zip/Postcode
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RH12 2DP
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Country
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United Kingdom
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Tel
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+44 (0)1403 210 406
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Fax
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+44 (0)1403 210 541
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Email
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info@actionresearch.co.uk
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Sponsor website:
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http://www.action.org.uk/
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Date applied
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01/03/2001
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Last edited
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12/01/2009
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Date ISRCTN assigned
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01/03/2001
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