Clinical trial NCT00352846
Conditions: Non-Hodgkin's Lymphoma Lymphoma
Keywords: Non-Hodgkin's Lymphoma Lymphoma Zoledronic Acid Zoledronate Zometa Vitamin D Calcium Carbonate Bone Loss
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-01-01; Completion date: 2011-09-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 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).

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 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 assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive standard care with calcium and Vitamin D alone. Participants in the other group will receive standard care with calcium and Vitamin D plus zoledronic acid. There is an equal chance of being assigned to either group. Both you and your study doctor will know if you are being treated with zoledronic acid.

You will be asked to come to the doctor's clinic 5 times over about 12 months (at the start of the study \[baseline\] and then every 3 months). Each visit should take about 1 hour. Participants in the zoledronic acid group will receive an infusion of zoledronic acid by vein at baseline and at 6 months into the study. The infusion will last about 30 minutes. This infusion procedure may or may not be done at the same time as your already scheduled chemotherapy treatment.

You will take calcium and Vitamin D pills while on study at amounts recommended for prevention of osteoporosis.

You will have a physical exam done at every visit. Various x-rays and/or bone density scans will be repeated after 12 months. Your doctor may also want to do additional bone density or x-ray scans if you have new symptoms or your symptoms get worse.

Before each treatment, you will have a blood test (about 1-2 teaspoons of blood) to make sure your kidneys are okay before each treatment with zoledronic acid. At each visit. your doctor or nurse will ask you how you are feeling and will ask about any medications you are taking or any medical problems you have had since your last visit. You will be asked to complete questionnaires about how you are feeling at certain visits. These questionnaires are 1 page long and should only take a few minutes to complete.

It is anticipated that your participation in this study will be 12 months. If your cancer gets worse, or if your doctor feels that you should be treated with a different medicine, you will be taken off of this study and your doctor will talk to you about other medicines that may be better for you.

Participants who received Zoledronic Acid will be contacted regularly to ask about any experience of osteonecrosis (bone death), for 10 years from the time they enroll on study. They will be interviewed by telephone call every 6 months.

This is an investigational study. Zoledronic acid is approved by the FDA for the treatment of high calcium levels in the blood. Zoledronic acid has not been approved by the FDA for what it is being used for in this study. After the treatment ends, you may continue to receive zoledronic acid or a similar drug, if your cancer doctor feels that it would help you. About 72 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Oral Vitamin D 400 mg daily + Calcium 1200 mg daily arm 2: Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m\^2 intravenous at baseline and 6 months.
Interventions: intervention 1: Zoledronic Acid intervention 2: Vitamin D intervention 3: Calcium Carbonate
Intervention descriptions: intervention 1: 4 mg/m\^2 by vein over 30 Minutes at baseline and 6 months. intervention 2: 400 mg by mouth daily intervention 3: 1200 mg by mouth daily

Protocol documents: