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ISRCTN
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ISRCTN57438091
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ClinicalTrials.gov identifier
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Public title
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Intravenous bisphosphonates in the prevention of osteoporosis associated with stroke
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Scientific title
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Acronym
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N/A
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Serial number at source
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LREC 01/245
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Study hypothesis
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The aim of this study is to investigate whether reductions in bone mineral density (BMD) in the hemiplegic hip of stroke patients can be prevented with the early use of a single dose of intravenous zoledronate. The study consists of a randomised double-blinded placebo-controlled trial of intravenous zoledronate (4 mg) to prevent bone loss in hemiplegic patients with acute stroke. Bone mineral density in both hemiplegic and unaffected hips of hemiplegic patients will be assessed, and patients will be randomised to receive a single infusion of either 4 mg zoledronic acid or placebo within 35 days of acute stroke. Serial measurements of hip bone mineral density will be made at 6 and 12 months in addition to detailed assessments of stroke recovery, functional status and balance.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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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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Stroke and osteoporosis
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Participants - inclusion criteria
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For inclusion, males and females aged 40-89 will be approached as soon as possible after admission with first ever stroke. Patients will be eligible if they were previously independently walking, have clinical and computed tomography (CT) evidence of stroke (haemorrhagic or ischaemic), are unable to walk 1 week following stroke (Functional Ambulatory Category [FAC] 0 or 1) and can give written informed consent to the study.
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Participants - exclusion criteria
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Exclusion criteria are as follows:
A. Not walking independently prior to stroke/previous stroke causing hemiplegia
B. Stroke not affecting the lower limb/FAC >1 at 1 week post stroke/posterior circulation stroke
C. Unconsciousness or terminal illness
D. Pre-existing dementia or cognitive impariment
E. Aphasia/significant language impairment
F. Renal/hepatic impairment
G. Aged <40 and >89
H. Prior treatment with a bisphosphonate, corticosteroids/known osteoporosis/unilateral bone disease affecting BMD/prior hip fracture or osteosynthetic material at the hip (e.g. hip replacement)
I. Unable to randomise and give infusion within 35 days of stroke (e.g. tertiary referrals from another hospital)
J. Current treatment with an aminoglycoside antibiotic
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Anticipated start date
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01/10/2001
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Anticipated end date
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22/09/2005
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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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30
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Interventions
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Intravenous zoledronate 4 mg versus placebo.
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Primary outcome measure(s)
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Bone mineral density at the hemiplegic hip 12 months following stroke.
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Secondary outcome measure(s)
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1. Bone mineral density at the unaffected hip 12 months following stroke
2. Histomorphometric analysis of bone biopsies from stroke patients treated with zoledronate or placebo
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Sources of funding
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National Osteoporosis Society (UK) RG33985
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17395868
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Contact name
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Dr
Elizabeth
Warburton
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Address
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Department of Clinical Neurosciences
Addenbrooke's Hospital
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Sponsor
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Cambridge University Hospitals NHS Foundation Trust (UK)
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Address
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Addenbrooke's Hospital
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Date applied
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02/08/2005
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Last edited
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08/06/2011
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Date ISRCTN assigned
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23/08/2005
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