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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01997 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
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The goal of this clinical research study is to learn if Actonel (risedronate) can help to prevent the development of osteoporosis (brittle and weak bones) caused by the steroid medication used to treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied.
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. Up to 80 eligible patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actonel | Active Comparator | Actonel (Risedronate) + Vitamin D + Calcium |
|
| Placebo | Placebo Comparator | Placebo + Vitamin D + Calcium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actonel (Risedronate) | Drug | 35 mg (pill) by mouth weekly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months | bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months. | 6 months |
| Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months | bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 12 months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria E. Cabanillas, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: February 06, 2004 to March 10, 2010. All participants were recruited at University of Texas (UT) MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Actonel | Actonel (Risedronate) + Vitamin D + Calcium Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months. |
| FG001 | Placebo | Placebo + Vitamin D + Calcium Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Actonel | Actonel (Risedronate) + Vitamin D + Calcium Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months | bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months. | Of 72 randomized, 22 participants in risedronate & 29 in placebo had at least a 6-month follow-up bone mineral density and were considered evaluable for the primary endpoint. Only 12/22 patients (55%) in risedronate and 7/29 patients (24%) in the placebo arm had 12 month DXA scan performed, mostly due to significant decreases in bone density. | Posted | Mean | Standard Deviation | Percent of change | 6 months |
|
Up to 6 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Actonel | Actonel (Risedronate) + Vitamin D + Calcium Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Cabanillas, Associate Professor, Endocrine Neoplasia and HD | University of Texas (UT) MD Anderson Cancer Center | (713) 563-0764 | mcabani@mdanderson.org |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Calcium | Dietary Supplement | 500 mg by mouth twice a day for a total of 24 months. |
|
| Vitamin D | Dietary Supplement | 400 IU by mouth twice a day for a total of 24 months. |
|
| Death |
|
| Bone Marrow Transplant |
|
| Too Ill to Continue |
|
| Failed to achieve complete response |
|
| Relapse |
|
| Fracture |
|
Placebo + Vitamin D + Calcium
Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo + Vitamin D + Calcium Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months. |
|
|
| Primary | Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months | bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 12 months | Posted | Mean | Standard Deviation | percentage of change | 12 months |
|
|
|
| 3 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo | Placebo + Vitamin D + Calcium Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months. | 1 | 36 | 0 | 36 | 0 | 36 |
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Left Hip 12 Months |
|