Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss

Completed · Phase 3

Conditions studied: Non-Hodgkin's Lymphoma, Lymphoma

In brief

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).

Key facts

Study ID

NCT00352846

Run by

M.D. Anderson Cancer Center

People needed

135

Starts

2006-01-01

Expected to finish

2011-09-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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