Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss

Launched by M.D. ANDERSON CANCER CENTER · Jul 13, 2006

Keywords

ClinConnect Summary

Medicines called "bisphosphonates" have been shown to help people with cancer that has spread to their bones. Zoledronic acid is a "bisphosphonate". Some bisphosphonates are pills that can be swallowed. Other bisphosphonates such as zoledronic acid need to be given by vein (or intravenously). Some studies have shown that people with multiple myeloma, breast cancer, and prostate cancer that had spread to the bone had less side effects from their bone disease when they were treated with bisphosphonates by vein.

If you are found to be eligible to take part in this study, you will be randomly ...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma.
• • 2. Prior Chemotherapy\</= 4 weeks of treatment.
• • 3. Age \>/= 18 years old.
• • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3.
• • 5. Estimated creatinine clearance \>/= 60 ml/min.
• • 6. Must sign an informed consent form.
• Exclusion Criteria:
• • 1. Radiologic evidence of vertebral or hip fracture.
• • 2. BMD T-score less than (i.e., worse than or more negative than) -2.0 at any of the following sites: lumbar spine, femoral neck, or total hip.
• • 3. Patients with secondary non-lymphomatous cancers metastatic to bone. However, other secondary cancers are allowed.
• • 4. Spinal cord compression due to vertebral collapse.
• • 5. Bisphosphonate treatment in the prior 6 months or steroid use (greater than 35 mg of prednisone equivalent steroids) in the prior 3 months. The use of topical, inhaled, or nasal steroids is allowed.
• • 6. Primary hyperparathyroidism.
• • 7. Active osteomalacia.
• • 8. Untreated hypocalcemia (ionized, iCa), Ionized Ca level must be within normal limits prior to enrollment.
• • 9. Untreated secondary hyperparathyroidism, Patients with abnormal parathyroid hormone (PTH) levels may be enrolled as long as they are being treated.
• • 10. Untreated vitamin D deficiency, Vitamin D level may be abnormal and patient may be enrolled as long as they are being treated.
• • 11. Untreated low testosterone (test in men only), testosterone level may be abnormal and patient may be enrolled as long as they are being treated.
• • 12. Paget's disease.
• • 13. Pregnant or breast-feeding.
• • 14. Radiotherapy involving the mandible.
• • 15. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), or of exposed bone in the mouth, or of slow healing after dental procedures.
• • 16. Recent (within 3 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).
• • 17. Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of \< 60 mL/minute.
• • 18. Known hypersensitivity to zoledronic acid or other bisphosphonates.
• • 19. Hypercalcemia: corrected Ca \> 10.2 mg/dL or ionized Ca \> 1.32 mmol/L