Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center Procter and Gamble |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00452439 |
Primary: To determine whether the use of Actonel decreases the amount of bone loss in Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) patients receiving chemotherapy with high dose steroids.
Secondary: To determine the CR (complete remission) rate in ALL and LL.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: Actonel (Risedronate) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blinded Study of Actonel for the Prevention of Bone Loss in Patients Receiving High Dose Corticosteroids for the Treatment of Acute Lymphocytic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) |
Estimated Enrollment: | 80 |
Study Start Date: | February 2004 |
One of the side effects of using high dose corticosteroids for the treatment of ALL is osteoporosis.
Risedronate is a medication that was designed to help prevent osteoporosis (brittle and weak bones).
Before treatment you will receive a complete physical exam. You will have around 1 tablespoon of blood drawn for blood tests (these tests are in addition to the routine blood tests you will have as part of the treatment for leukemia). You will have a urine sample collected for routine tests. You will also have a bone mineral density test. This test measures the density of the bones in your spine, hip, and total body. The test is similar to having x-rays of your bones taken.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in the first group will be given risedronate (once per week), vitamin D (once per day), and calcium (once per day). All three medications are pills and will be taken by mouth. Participants in the second group will be given placebo (once per week), vitamin D (once per day), and calcium (once per day). All three medications are pills and will be taken by mouth. A placebo is a substance that looks like the study drug but has no active ingredients.
Neither you nor your doctor will know to which group you are assigned. However, if it is needed for your care, the information will be given to your doctor.
Participants in both groups will continue to receive chemotherapy during this study as scheduled. During chemotherapy, you will have around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests (as part of the standard of care for your treatment of leukemia).
For this study, you will have urine samples collected and repeat bone mineral density tests 6 months, 12 months, 18 months, and 24 months after starting the study drug (or placebo).
If you develop intolerable side effects from the risedronate you will be taken off the study.
This is an investigational study. Risedronate is FDA approved and commercially available. Risedronate will be provided free of charge while you are enrolled in this study. Up to 80 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: Maria E. Cabanillas, MD | 713-745-0654 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Maria E. Cabanillas, MD |
Principal Investigator: | Maria E. Cabanillas, MD | U.T.M.D. Anderson Cancer Center |
Study ID Numbers: | ID03-0124 |
Study First Received: | March 23, 2007 |
Last Updated: | October 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00452439 History of Changes |
Health Authority: | United States: Institutional Review Board |
Leukemia Lymphoma Acute Lymphocytic Leukemia Lymphoblastic Lymphoma |
Actonel Risedronate Bone Loss Osteoporosis |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Calcium Channel Blockers Osteoporosis Bone Density Conservation Agents Cardiovascular Agents Lymphoblastic Lymphoma |
Leukemia Lymphatic Diseases Calcium, Dietary Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia Risedronic acid |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents |
Pharmacologic Actions Membrane Transport Modulators Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Lymphoma Risedronic acid |