Condition category
Circulatory System
Date applied
02/08/2005
Date assigned
23/08/2005
Last edited
08/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Warburton

ORCID ID

Contact details

Department of Clinical Neurosciences
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

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

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes