Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452439
Status:
COMPLETED
Last Update Posted:
2020-12-28
First Post:
2007-03-23
Brief Title:
A Study of Actonel for the Prevention of Bone Loss
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-01997 | REGISTRY | NCI CTRP | None |