Stroke and osteoporosis Circulatory System Stroke and osteoporosis
Conditions
Interventions
Intravenous zoledronate 4 mg versus placebo.
Sponsors
Cambridge University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density at the hemiplegic hip 12 months following stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed