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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN57438091 |
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Date of registration:
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23/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/10/2001 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN57438091 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Prevention)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Elizabeth
Warburton |
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Address:
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Department of Clinical Neurosciences
Addenbrooke's Hospital
Hills Road
CB2 2QQ
Cambridge
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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.
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke and osteoporosis
Circulatory System
Stroke and osteoporosis
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Intervention(s)
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Intravenous zoledronate 4 mg versus placebo.
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Primary Outcome(s)
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Bone mineral density at the hemiplegic hip 12 months following stroke.
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Secondary Outcome(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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Secondary ID(s)
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LREC 01/245
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Source(s) of Monetary Support
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National Osteoporosis Society (UK) RG33985
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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