Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352846
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2006-07-13
Brief Title:
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss in Non-Hodgkins Lymphoma Patients Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2013-06
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:
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
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 doctors 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 andor 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
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 doctors 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 andor 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
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