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ISRCTN
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ISRCTN36205515
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ClinicalTrials.gov identifier
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Public title
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Zoledronate on bone mineral density in patients with cancer remission and anti-neoplastic treatment induced bone loss
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Scientific title
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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
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Acronym
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Annual zoledronate
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Serial number at source
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1195
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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South Sheffield LREC approved on the 3rd September 2001 (ref: SSLREC/01/113)
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Study design
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Multicentre non-randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: Breast, Colon, Lymphoma (Hodgkin's), Lymphoma (non-Hodgkin's), Testis, Melanoma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2001
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Anticipated end date
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01/10/2005
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 80
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Interventions
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Zoledronic acid 4 mg intravenously once a year. DEXA scans at baseline, 1, and 2 years of lumbar spine and hip
Study entry: other
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Primary outcome measure(s)
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Change in BMD at hip and spine, measured by DEXA scan at 1 and 2 years
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Secondary outcome measure(s)
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Improvement in bone resorption marker levels, measured at 0, 6, 12, 18, 24, 36, 48 and 60 months.
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Sources of funding
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Weston Park Cancer Appeal (UK)
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Trial website
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Publications
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Contact name
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Prof
Robert E
Coleman
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Address
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Department of Clinical Oncology
Weston Park Hospital
Whitham Road
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City/town
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Sheffield
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Zip/Postcode
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S10 2SJ
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Country
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United Kingdom
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Email
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r.e.coleman@sheffield.ac.uk
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Sponsor
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University of Sheffield (UK)
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Address
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Royal Hallamshire Hospital
Glossop Road
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City/town
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Sheffield
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Zip/Postcode
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S10 2JF
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Country
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United Kingdom
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Email
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R.J.Hudson@sheffield.ac.uk
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Sponsor website:
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http://www.sheffield.ac.uk/
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Date applied
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30/06/2010
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Last edited
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05/08/2010
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Date ISRCTN assigned
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30/06/2010
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