Zoledronate to prevent bone loss in acute multiple sclerosis
| ISRCTN | ISRCTN87039596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87039596 |
| Protocol serial number | CZOL446HGB15T |
| Sponsor | North Bristol NHS Trust (UK) |
| Funder | Novartis Pharmaceuticals (UK) |
- 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
Scientific
Academic Rheumatology
Avon Orthopaedic Centre
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomised two-arm placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Zoledronate |
| Primary outcome measure(s) |
A significant difference in serum type I collagen C-telopeptides (CTX) according to treatment group at day 7 of the study |
| Key secondary outcome measure(s) |
Increased bone mineral density (BMD), measured at days 7, 90,180 and 360 |
| 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 | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Academic Rheumatology
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
