Intravenous bisphosphonates in the prevention of osteoporosis associated with stroke
| ISRCTN | ISRCTN57438091 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57438091 |
| Secondary identifying numbers | LREC 01/245 |
- Submission date
- 02/08/2005
- Registration date
- 23/08/2005
- Last edited
- 08/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Elizabeth Warburton
Scientific
Scientific
Department of Clinical Neurosciences
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Stroke and osteoporosis |
| Intervention | Intravenous zoledronate 4 mg versus placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Zoledronate |
| Primary outcome measure | 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 study start date | 01/10/2001 |
| Completion date | 22/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 22/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Clinical Neurosciences
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
"ROR" |
https://ror.org/04v54gj93 |
|---|
Funders
Funder type
Charity
National Osteoporosis Society (UK) RG33985
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2007 | Yes | No |
