Contact information
Type
Scientific
Primary contact
Prof Robert E Coleman
ORCID ID
Contact details
Department of Clinical Oncology
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
+44 114 226 5213
r.e.coleman@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1195
Study information
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
Acronym
Annual zoledronate
Study hypothesis
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
South Sheffield LREC approved on the 3rd September 2001 (ref: SSLREC/01/113)
Study design
Multicentre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2001
Overall trial end date
01/10/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 80
Participant 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
Recruitment start date
01/09/2001
Recruitment end date
01/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Oncology
Sheffield
S10 2SJ
United Kingdom
Sponsor information
Organisation
University of Sheffield (UK)
Sponsor details
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 114 22 21448
R.J.Hudson@sheffield.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Weston Park Cancer Appeal (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A follow up long term follow-up publication is planned for late 2015/early 2016.
Intention to publish date
01/02/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results 2007: http://www.ncbi.nlm.nih.gov/pubmed/17875770