Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LREC 01/245
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Stroke and osteoporosis
Intervention
Intravenous zoledronate 4 mg versus placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Zoledronate
Primary outcome measures
Bone mineral density at the hemiplegic hip 12 months following stroke.
Secondary outcome measures
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
Overall trial start date
01/10/2001
Overall trial end date
22/09/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/10/2001
Recruitment end date
22/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Neurosciences
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Charity
Funder name
National Osteoporosis Society (UK) RG33985
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17395868
Publication citations
-
Results
Poole KE, Loveridge N, Rose CM, Warburton EA, Reeve J, A single infusion of zoledronate prevents bone loss after stroke., Stroke, 2007, 38, 5, 1519-1525, doi: 10.1161/STROKEAHA.106.474262.