Hematological MalignanciesPhase 3NCT00824993
Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients
A Phase 3 study testing Ibandronate and Vitamin Supplements in people with Hematological Malignancies, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to see if ibandronate can help to slow the rate of bone loss that may occur in patients who have received a bone marrow transplant for blood cancer. This study plans to address the following hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Ibandronate and Vitamin Supplements
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2008to 7 Apr 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years.
- Patients with the diagnosis of hematologic malignancies or hematological disorders, who are immediately post- allogeneic bone marrow transplantation.
- Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.
- Negative pregnancy test in premenopausal patients.
- Patients with GVHD or infections can be entered only if they respond to treatment and become controlled.
- Dental considerations: patients with negative dental screening for jaw osteonecrosis 0-3 months prior to their transplant and patients that do not have a plan for tooth extraction in the near future.
Who cannot join
- Patients with documented relapsed malignancy or recurrence of the original hematological disorder after the transplant, uncontrolled acute GVHD, or uncontrolled infection.
- Patients with hypocalcemia of less than 8.4 (corrected to account for the albumin level).
- Patients with hypercalcemia >12.2, due to a cause not related to their hematological malignancy or hematological disorder (i.e. hyperparathyroidism, multiple myeloma).
- Hypersensitivity to Ibandronate or other bisphosphonates.
- Pre-existing osteoporosis, defined as a bone density T-score of -2.5 S.D. or less.
- Renal insufficiency (calculated creatinine clearance < 30 ml/min).
Show all 11Show fewer
- Patients already on bisphosphonates (over the past two years), calcitonin, anabolic steroids, or daily oral fluoride supplement.
- Myeloma patients who have previously been on bisphosphonates over the past two years and/or have active bone lesions.
- If corrected calcium is above 10.3 and the immunoreactive parathyroid hormone (iPTH) is elevated or normal, the patient will be excluded from the study.
- Patients with a 25-hydroxyvitamin D concentration <20 ng/ml and evidence of osteomalacia (low ionized calcium and elevated intact PTH).
- Dental considerations: Patients with recent tooth extraction with signs of incomplete healing or significant infection will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized, Controlled Study of Ibandronate for the Prevention of Bone Loss in Patients Who Have Received Allogeneic Bone Marrow Transplantation for Hematological Malignancies
The goal of this clinical research study is to see if ibandronate can help to slow the rate of bone loss that may occur in patients who have received a bone marrow transplant for blood cancer.
This study plans to address the following hypotheses:
Read more
- The addition of Ibandronate initiated immediately after the transplantation will prevent bone loss in patients undergoing allogenic bone marrow transplantation (BMT) with underlying hematologic malignancies or hematologic disorders.
- BMT patients who require prolonged steroid and other immunosuppressive treatment for Graft versus Host Diseases(GVHD) have a higher rate of bone loss, which can be prevented or attenuated by Ibandronate.
Specific objectives to test these hypotheses are:
- Primary Objective:
- To prospectively compare the bone mineral density changes of lumbar spine, femoral neck and total hip between patients randomly assigned to ibandronate and control group over 12 months post bone marrow transplantation at the University of Texas MD Anderson Cancer Center.
- Secondary Objectives:
- To measure and compare the accumulated level of steroid used in both treatment and control groups.
- To collect and compare the level of serum C-terminal telopeptide (CTX) in both treatment and control groups to monitor the bone turnover rate for the duration of the study.
- To conduct a cost-effectiveness analysis of participating patients for both outcomes on bone mineral density (measured data) and skeletal-related events (modeled data).
- To record incidence of bone fractures and the graft rate in both treatment and control groups.
Read the detailed description
The Study Drug:
Ibandronate is designed to slow the rate of bone loss.
Screening Process:
Before you can receive the study drug, the study doctor will check the results of various tests that you recently had performed as part of standard care for the bone marrow transplant. These test results will help the doctor decide if you are eligible to take part in this study.
Study Groups:
If you are found to be eligible to take part in the study and you choose to take part, you will be randomly assigned (as in the toss of a coin) to 1 of 2 study groups. Group 1 (the "treatment" group) will receive ibandronate in addition to calcium and vitamin D supplements. Group 2 will only receive the calcium and vitamin D supplements. The chance of being in either group is equal.
Study Visits:
For both groups, you will be visited by a research team member during your hospital stay soon after the transplant (at Month Zero [0]), and during routine visits to your transplant doctor's office at Months 3, 6, and 9 after the transplant. At each of these study visits, you will be asked how you are feeling, as well as whether you have had any bone fractures (breakages).
At Months 0, 3, 6, and 9 after the transplant, blood (up to 1 tablespoon each time) will be drawn for routine tests for your transplant follow-up. As part of this same blood draw, an additional ½ tablespoon of blood will be drawn during each study visit (at Months 0, 3, 6, and 9). This blood will be tested for a "marker" in the bone that may help researchers predict who may respond to treatment.
If you are in the "treatment" group, you will receive a total of 4 ibandronate infusions by vein (over 15-30 seconds each time). These study drug infusions will take place in the hospital or at your routine visit to the transplant doctor's office at 3-6 weeks after the transplant, and at Months 3, 6, and 9 after the transplant.
At Month 6, all study participants will have a study-related (non-routine) bone density test (an x-ray) performed to check for bone loss. If the test results show that you have lost an abnormally large amount of bone mineral, you will be taken off study and also advised about treatment options.
Vitamin Supplements:
All study participants will receive a supply of calcium and vitamin D to take at home, for general bone health. These supplements should be taken by mouth, twice a day for 12 months. If you do not tolerate the supplements provided by the research study, you may take another brand of calcium/Vitamin D that you buy over-the-counter. The doses that you take each time (twice daily) should be 500 mg for calcium and 400 International Units (IU) for Vitamin D.
Cost Analysis:
Researchers on this study also want to look at how cost-effective the different procedures and treatments are on this study. To do this, they will use information from your patient records, pharmacy records, and other information of yours on M. D. Anderson databases. You will not be asked to actively participate in any interviews or procedures for these studies, but you should be aware that this research will take place while you are study.
End-of-Study Visit:
You will be visited by a research team member during your routine visit to your transplant doctor's office at Month 12 after the transplant. At this visit, you will be asked how you are feeling as well as whether you have had any bone fractures. Your doctor will check this by x-ray, if you do not have an outside x-ray film available. Blood (up to 1 tablespoon) will be drawn for routine tests. As part of this same blood draw, an additional ½ tablespoon of blood will be drawn to test for the same bone marker. You will have a routine bone density test (an x-ray) performed to check for bone loss. After these tests, your participation in this study will be over.
This is an investigational study. Ibandronate is commercially available and FDA approved for use in the prevention and treatment of bone loss in women who have been through menopause. However, its use in slowing the rate of bone loss in patients who have had a bone marrow transplant is considered experimental. For this purpose, the M. D. Anderson Institutional Review Board (IRB) has authorized the use of ibandronate for research only. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner.
Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Hematological Malignancies
- Being tested
- Ibandronate, Vitamin Supplements
- Keywords
- Blood Cancer, Calcium, Vitamin D, Ibandronate, Boniva, Hematological Malignancies, Bone Marrow Transplantation, BMT, Osteoporosis, Bone Loss, Allogeneic Bone Marrow Transplantation
- Medical subject headings
- Hematologic Neoplasms, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbandronateDrug
Also called Boniva
Infusion of 3 mg by vein over 15 to 30 seconds for 4 doses at 3-6 weeks after transplant, and at Months 3, 6, and 9 after the transplant.
Vitamin SupplementsDrug
Calcium 500 mg by mouth everyday for 12 months
Vitamin D 400 units by mouth 2 times a day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate + Calcium + Vitamin D | Experimental | Ibandronate infusion of 3 mg by vein over 15 to 30 seconds for 4 doses at 3-6 weeks after transplant, and at Months 3, 6, and 9 after the transplant. Calcium 500 mg by mouth everyday for 12 months. Vitamin D 400 units by mouth 2 times a day for 12 months. Receives: Drug: Ibandronate; Drug: Vitamin Supplements |
| Calcium + Viatmin D | Experimental | Calcium 500 mg by mouth everyday for 12 months. Vitamin D 400 units by mouth 2 times a day for 12 months. Receives: Drug: Vitamin Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline.
Measured: Baseline to 6 months and Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study start9 Dec 2008
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Huifang Lu, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824993
- Sponsor's protocol ID
- 2006-0960
- Other IDs
- NCI-2010-01024
- Status last verified
- Sep 2018
- First submitted
- 15 Jan 2009
- Last updated
- 13 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of Ibandronate for the Prevention of Bone Loss in Patients Who Have Received Allogeneic Bone Marrow Transplantation for Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00824993
- Acronym / sponsor ID
- 2006-0960
- Conditions
- Hematological Malignancies
- Keywords
- Blood Cancer, Calcium, Vitamin D, Ibandronate, Boniva, Hematological Malignancies, Bone Marrow Transplantation, BMT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 9 Dec 2008 (actual)
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to see if ibandronate can help to slow the rate of bone loss that may occur in patients who have received a bone marrow transplant for blood cancer.
This study plans to address the following hypotheses:
- The addition of Ibandronate initiated immediately after the transplantation will prevent bone loss in patients undergoing allogenic bone marrow transplantation (BMT) with underlying hematologic malignancies or hematologic disorders.
- BMT patients who require prolonged steroid and other immunosuppressive treatment for Graft versus Host Diseases(GVHD) have a higher rate of bone loss, which can be prevented or attenuated by Ibandronate.
Specific objectives to test these hypotheses are:
- Primary Objective:
- To prospectively compare the bone mineral density changes of lumbar spine, femoral neck and total hip between patients randomly assigned to ibandronate and control group over 12 months post bone marrow transplantation at the University of Texas MD Anderson Cancer Center.
- Secondary Objectives:
- To measure and compare the accumulated level of steroid used in both treatment and control groups.
- To collect and compare the level of serum C-terminal telopeptide (CTX) in both treatment and control groups to monitor the bone turnover rate for the duration of the study.
- To conduct a cost-effectiveness analysis of participating patients for both outcomes on bone mineral density (measured data) and skeletal-related events (modeled data).
- To record incidence of bone fractures and the graft rate in both treatment and control groups.
Detailed description
The Study Drug:
Ibandronate is designed to slow the rate of bone loss.
Screening Process:
Before you can receive the study drug, the study doctor will check the results of various tests that you recently had performed as part of standard care for the bone marrow transplant. These test results will help the doctor decide if you are eligible to take part in this study.
Study Groups:
If you are found to be eligible to take part in the study and you choose to take part, you will be randomly assigned (as in the toss of a coin) to 1 of 2 study groups. Group 1 (the "treatment" group) will receive ibandronate in addition to calcium and vitamin D supplements. Group 2 will only receive the calcium and vitamin D supplements. The chance of being in either group is equal.
Study Visits:
For both groups, you will be visited by a research team member during your hospital stay soon after the transplant (at Month Zero [0]), and during routine visits to your transplant doctor's office at Months 3, 6, and 9 after the transplant. At each of these study visits, you will be asked how you are feeling, as well as whether you have had any bone fractures (breakages).
At Months 0, 3, 6, and 9 after the transplant, blood (up to 1 tablespoon each time) will be drawn for routine tests for your transplant follow-up. As part of this same blood draw, an additional ½ tablespoon of blood will be drawn during each study visit (at Months 0, 3, 6, and 9). This blood will be tested for a "marker" in the bone that may help researchers predict who may respond to treatment.
If you are in the "treatment" group, you will receive a total of 4 ibandronate infusions by vein (over 15-30 seconds each time). These study drug infusions will take place in the hospital or at your routine visit to the transplant doctor's office at 3-6 weeks after the transplant, and at Months 3, 6, and 9 after the transplant.
At Month 6, all study participants will have a study-related (non-routine) bone density test (an x-ray) performed to check for bone loss. If the test results show that you have lost an abnormally large amount of bone mineral, you will be taken off study and also advised about treatment options.
Vitamin Supplements:
All study participants will receive a supply of calcium and vitamin D to take at home, for general bone health. These supplements should be taken by mouth, twice a day for 12 months. If you do not tolerate the supplements provided by the research study, you may take another brand of calcium/Vitamin D that you buy over-the-counter. The doses that you take each time (twice daily) should be 500 mg for calcium and 400 International Units (IU) for Vitamin D.
Cost Analysis:
Researchers on this study also want to look at how cost-effective the different procedures and treatments are on this study. To do this, they will use information from your patient records, pharmacy records, and other information of yours on M. D. Anderson databases. You will not be asked to actively participate in any interviews or procedures for these studies, but you should be aware that this research will take place while you are study.
End-of-Study Visit:
You will be visited by a research team member during your routine visit to your transplant doctor's office at Month 12 after the transplant. At this visit, you will be asked how you are feeling as well as whether you have had any bone fractures. Your doctor will check this by x-ray, if you do not have an outside x-ray film available. Blood (up to 1 tablespoon) will be drawn for routine tests. As part of this same blood draw, an additional ½ tablespoon of blood will be drawn to test for the same bone marker. You will have a routine bone density test (an x-ray) performed to check for bone loss. After these tests, your participation in this study will be over.
This is an investigational study. Ibandronate is commercially available and FDA approved for use in the prevention and treatment of bone loss in women who have been through menopause. However, its use in slowing the rate of bone loss in patients who have had a bone marrow transplant is considered experimental. For this purpose, the M. D. Anderson Institutional Review Board (IRB) has authorized the use of ibandronate for research only. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner.
Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibandronate + Calcium + Vitamin D | Experimental | Drug: Ibandronate, Drug: Vitamin SupplementsIbandronate infusion of 3 mg by vein over 15 to 30 seconds for 4 doses at 3-6 weeks after transplant, and at Months 3, 6, and 9 after the transplant. Calcium 500 mg by mouth everyday for 12 months. Vitamin D 400 units by mouth 2 times a day for 12 months. |
| Calcium + Viatmin D | Experimental | Drug: Vitamin SupplementsCalcium 500 mg by mouth everyday for 12 months. Vitamin D 400 units by mouth 2 times a day for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years.
- Patients with the diagnosis of hematologic malignancies or hematological disorders, who are immediately post- allogeneic bone marrow transplantation.
- Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.
- Negative pregnancy test in premenopausal patients.
- Patients with GVHD or infections can be entered only if they respond to treatment and become controlled.
Key exclusion criteria (11 listed)
- Patients with documented relapsed malignancy or recurrence of the original hematological disorder after the transplant, uncontrolled acute GVHD, or uncontrolled infection.
- Patients with hypocalcemia of less than 8.4 (corrected to account for the albumin level).
- Patients with hypercalcemia >12.2, due to a cause not related to their hematological malignancy or hematological disorder (i.e. hyperparathyroidism, multiple myeloma).
- Hypersensitivity to Ibandronate or other bisphosphonates.
- Pre-existing osteoporosis, defined as a bone density T-score of -2.5 S.D. or less.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbandronateAlso: BonivaInfusion of 3 mg by vein over 15 to 30 seconds for 4 doses at 3-6 weeks after transplant, and at Months 3, 6, and 9 after the transplant. | Drug | Ibandronate + Calcium + Vitamin D |
| Vitamin SupplementsCalcium 500 mg by mouth everyday for 12 months Vitamin D 400 units by mouth 2 times a day for 12 months | Drug | Calcium + Viatmin D, Ibandronate + Calcium + Vitamin D |
Primary outcome
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
Time frame: Baseline to 6 months and Baseline to 12 months
The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huifang Lu, MD, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibandronate and Vitamin Supplements in people with Hematological Malignancies, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months (time frame: Baseline to 6 months and Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.