Zoledronate to prevent bone loss in acute multiple sclerosis

ISRCTN	ISRCTN87039596
DOI	https://doi.org/10.1186/ISRCTN87039596
Secondary identifying numbers	CZOL446HGB15T

Submission date: 08/04/2009
Registration date: 05/05/2009
Last edited: 11/08/2014

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jonathan Tobias
Scientific

Academic Rheumatology
Avon Orthopaedic Centre
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Study information

Study design	Single-blind randomised two-arm placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial to evaluate whether zoledronate prevents bone loss in acute multiple sclerosis
Study objectives	That a single dose of intravenous zoledronate 5 mg immediately prior to intravenous corticosteroid therapy will prevent the bone thinning effect of the steroid, therefore reducing the risk of a fracture.
Ethics approval(s)	South West Research Ethics Committee, 13/02/2009, ref: 08/H0206/76
Health condition(s) or problem(s) studied	Multiple sclerosis
Intervention	A single dose of intravenous zoledronate 5 mg/placebo prior to commencement of intravenous corticosteroid for acute exacerbation of multiple sclerosis symptoms. Blood samples taken on days 1, 2, 3, 7, 90, 180 and 360. Dual energy X-ray absorptiometry (DXA) scans taken on day 7, 90, 180 and 360. Updated 11/08/2014: this trial was halted prematurely due to problems with recruitment.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Zoledronate
Primary outcome measure	A significant difference in serum type I collagen C-telopeptides (CTX) according to treatment group at day 7 of the study
Secondary outcome measures	Increased bone mineral density (BMD), measured at days 7, 90,180 and 360
Overall study start date	20/04/2009
Completion date	31/12/2011
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Aged 18 - 65 years (either sex) with a diagnosis of multiple sclerosis (MS) 2. Acute flare up requiring treatment with a corticosteroid 3. Able to attend for study investigations and assessments 4. Willing and able to provide informed consent
Key exclusion criteria	1. Previous diagnosis of osteoporosis 2. Bone therapy within previous 12 months 3. Previous bisphosphonate therapy at any time 4. Associated disorder that may affect bone metabolism 5. Pregnancy 6. Breastfeeding
Date of first enrolment	20/04/2009
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Rheumatology

Bristol
BS10 5NB
United Kingdom

Sponsor information

North Bristol NHS Trust (UK)
Hospital/treatment centre

c/o Margaret Stoddart
R&D Manager Governance
Coach House
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
England
United Kingdom

Website	http://www.nbt.nhs.uk/
"ROR"	https://ror.org/036x6gt55

Funders

Funder type

Industry

Novartis Pharmaceuticals (UK)

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?
HRA research summary			28/06/2023	No	No