Status:
COMPLETED
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Novartis
Conditions:
Non-Hodgkin's Lymphoma
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 zoledronat...
Detailed Description
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 swallowe...
Eligibility Criteria
Inclusion
- Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma.
- Prior Chemotherapy\</= 4 weeks of treatment.
- Age \>/= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3.
- Estimated creatinine clearance \>/= 60 ml/min.
- Must sign an informed consent form.
Exclusion
- Radiologic evidence of vertebral or hip fracture.
- 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.
- Patients with secondary non-lymphomatous cancers metastatic to bone. However, other secondary cancers are allowed.
- Spinal cord compression due to vertebral collapse.
- 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.
- Primary hyperparathyroidism.
- Active osteomalacia.
- Untreated hypocalcemia (ionized, iCa), Ionized Ca level must be within normal limits prior to enrollment.
- Untreated secondary hyperparathyroidism, Patients with abnormal parathyroid hormone (PTH) levels may be enrolled as long as they are being treated.
- Untreated vitamin D deficiency, Vitamin D level may be abnormal and patient may be enrolled as long as they are being treated.
- Untreated low testosterone (test in men only), testosterone level may be abnormal and patient may be enrolled as long as they are being treated.
- Paget's disease.
- Pregnant or breast-feeding.
- Radiotherapy involving the mandible.
- 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.
- Recent (within 3 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).
- 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.
- Known hypersensitivity to zoledronic acid or other bisphosphonates.
- Hypercalcemia: corrected Ca \> 10.2 mg/dL or ionized Ca \> 1.32 mmol/L
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00352846
Start Date
January 1 2006
End Date
September 1 2011
Last Update
July 2 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030