Topic: National Cancer Research Network
Conditions
Interventions
Zoledronic acid 4 mg intravenously once a year. DEXA scans at baseline, 1, and 2 years of lumbar spine and hip
Study entry: other
Sponsors
University of Sheffield (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMD at hip and spine, measured by DEXA scan at 1 and 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in bone resorption marker levels, measured at 0, 6, 12, 18, 24, 36, 48 and 60 months. | — |
Countries
United Kingdom
Outcome results
None listed