Trial Information

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 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.