Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
Condition: Non-Hodgkin's Lymphoma; Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Zoledronic Acid; Vitamin D; Calcium Carbonate
Intervention description: 4 mg/m^2 by vein over 30 Minutes at baseline and 6 months.; 400 mg by mouth daily; 1200 mg by mouth daily
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Calcium Carbonate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's Lymphoma; Lymphoma; Zoledronic Acid; Zoledronate; Zometa; Vitamin D; Calcium Carbonate; Bone Loss

Summary:

      Primary Objective:

        -  Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total
           lumbar spine and femoral neck.

      Secondary Objectives:

        -  Evaluate the effect of zoledronate on change in BMD at the total hip

        -  Evaluate risk factors for developing osteoporosis on chemotherapy

        -  Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect
           on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with
           calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).
    

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