Intravenous bisphosphonates in the prevention of osteoporosis associated with stroke
- Conditions
- Stroke and osteoporosisCirculatory System
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone mineral density at the hemiplegic hip 12 months following stroke.
- Secondary Outcome Measures
Name Time Method 1. Bone mineral density at the unaffected hip 12 months following stroke<br>2. Histomorphometric analysis of bone biopsies from stroke patients treated with zoledronate or placebo