Zoledronate on bone mineral density in patients with cancer remission and anti-neoplastic treatment induced bone loss
| ISRCTN | ISRCTN36205515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36205515 |
| Secondary identifying numbers | 1195 |
- Submission date
- 30/06/2010
- Registration date
- 30/06/2010
- Last edited
- 09/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Robert E Coleman
Scientific
Scientific
Department of Clinical Oncology
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
| Phone | +44 114 226 5213 |
|---|---|
| r.e.coleman@sheffield.ac.uk |
Study information
| Study design | Multicentre non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | GP practice |
| 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 | Effect of an annual infusion of zoledronate on bone mineral density in patients on long term follow up with cancer remission and anti-neoplastic treatment induced bone loss study |
| Study acronym | Annual zoledronate |
| Study objectives | No previous study has been carried out in men and women in long term remission from cancers such as breast cancer, lymphoma and testicular cancer with treatment induced osteopenia or osteoporosis. The aim of the proposed study was to determine whether in such patients, an annual 4 mg dose of intraveous (IV) zoledronic acid results in significant increase in bone mineral density (BMD) measured one year later. Further more to assess whether any benefit obtained in such patients is maintained. |
| Ethics approval(s) | South Sheffield LREC approved on the 3rd September 2001 (ref: SSLREC/01/113) |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: Breast, Colon, Lymphoma (Hodgkin's), Lymphoma (non-Hodgkin's), Testis, Melanoma |
| Intervention | Zoledronic acid 4 mg intravenously once a year. DEXA scans at baseline, 1, and 2 years of lumbar spine and hip Study entry: other |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Zoledronic acid |
| Primary outcome measure | Change in BMD at hip and spine, measured by DEXA scan at 1 and 2 years |
| Secondary outcome measures | Improvement in bone resorption marker levels, measured at 0, 6, 12, 18, 24, 36, 48 and 60 months. |
| Overall study start date | 01/09/2001 |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 80 |
| Key inclusion criteria | 1. Histologically proven malignant disease 2. Complete response of primary disease to chemotherapy and/or radiotherapy and no evidence of metastases 3. Osteoporosis or osteopaenia (as defined by World Health Organization [WHO] criteria) at screening dual energy x-ray absorptiometry (DEXA) scan 4. Confirmation of post-menopausal status (female patients) as determined by serum follicle-stimulating hormone (FSH) greater than 15 mU/ml and oestradiol levels of less than 30 pg/ml 5. Aged 18 years or above 6. Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2 7. No previous treatment with bisphosphonate 8. No treatment with anabolic steroids, fluoride, calcitonin or vitamin D within the last six months 9. No change in endocrine therapy in last three months 10. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 11. Written informed consent |
| Key exclusion criteria | 1. Abnormal renal function (serum creatinine level greater than 130 µM/L or greater than 1.5 mg/dL) 2. Pregnancy/lactation (female patients) 3. Other disorders of bone metabolism e.g., Paget's disease, hyperparathyroidism, renal osteodystrophy |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Clinical Oncology
Sheffield
S10 2SJ
United Kingdom
S10 2SJ
United Kingdom
Sponsor information
University of Sheffield (UK)
University/education
University/education
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom
| Phone | +44 114 22 21448 |
|---|---|
| R.J.Hudson@sheffield.ac.uk | |
| Website | http://www.sheffield.ac.uk/ |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Charity
Weston Park Cancer Appeal (UK)
No information available
Results and Publications
| Intention to publish date | 01/02/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | A follow up long term follow-up publication is planned for late 2015/early 2016. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results : | 15/09/2007 | Yes | No |
