Condition category
Nervous System Diseases
Date applied
08/04/2009
Date assigned
05/05/2009
Last edited
11/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jonathan Tobias

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZOL446HGB15T

Study information

Scientific title

A randomised controlled trial to evaluate whether zoledronate prevents bone loss in acute multiple sclerosis

Acronym

Study hypothesis

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

South West Research Ethics Committee, 13/02/2009, ref: 08/H0206/76

Study design

Single-blind randomised two-arm placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase IV

Drug names

Zoledronate

Primary outcome measures

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 trial start date

20/04/2009

Overall trial end date

31/12/2011

Reason abandoned

Participant recruitment issue

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

20/04/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Rheumatology
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.nbt.nhs.uk/

Funders

Funder type

Industry

Funder name

Novartis Pharmaceuticals (UK)

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

Publication citations

Additional files

Editorial Notes