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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00352846 |
Primary Objective:
-Evaluate the effect of zoledronate on change in BMD at the total lumbar spine and femoral neck.
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma Lymphoma |
Drug: Zoledronic Acid Drug: Vitamin D Drug: Calcium Carbonate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss in Non-Hodgkin's Lymphoma Patients Receiving Chemotherapy |
Estimated Enrollment: | 106 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Vitamin D + Calcium Carbonate
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Drug: Vitamin D
400 mg PO Daily
Drug: Calcium Carbonate
1200 mg PO Daily
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2: Experimental
Vitamin D + Calcium Carbonate + Zoledronic Acid
|
Drug: Zoledronic Acid
4 mg/m^2 IV Over 30 Minutes at baseline and 6 months.
Drug: Vitamin D
400 mg PO Daily
Drug: Calcium Carbonate
1200 mg PO Daily
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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.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will be asked questions about your health and any medications you are taking, and your medical history will be recorded. You will have a physical exam, including measurement of height, weight, blood pressure, and heart rate. You will have blood (about 2 tablespoons) and urine samples taken for routine tests. X-rays and bone density scans will be done to look for bone fractures, bone health, and to measure your bone. Women who are able to have children must have a negative blood or urine pregnancy test.
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 twice daily 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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fredrick Hagemeister, MD | 713-792-2860 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Fredrick Hagemeister, MD |
Principal Investigator: | Fredrick Hagemeister, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Fredrick Hagemeister, MD/Professor ) |
Study ID Numbers: | 2005-0698 |
Study First Received: | July 13, 2006 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00352846 |
Health Authority: | United States: Institutional Review Board |
Non-Hodgkin's Lymphoma Lymphoma Zoledronic Acid Vitamin D |
Calcium Carbonate Zometa Bone Loss |
Calcium, Dietary Lymphatic Diseases Diphosphonates Vitamin D Zoledronic acid Immunoproliferative Disorders |
Ergocalciferols Lymphoma, small cleaved-cell, diffuse Calcium Carbonate Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Growth Substances Vitamins |
Physiological Effects of Drugs Bone Density Conservation Agents Antacids Micronutrients Pharmacologic Actions |