Zoledronate on bone mineral density in patients with cancer remission and anti-neoplastic treatment induced bone loss

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: Breast, Colon, Lymphoma (Hodgkin's), Lymphoma (non-Hodgkin's), Testis, Melanoma; Cancer; Anti-neoplastic treatment induced bone loss

• Registration Number: ISRCTN36205515
• Lead Sponsor: niversity of Sheffield (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-30
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified