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A Randomized, Controlled Study of Ibandronate for the Prevention of Bone Loss in Patients Who Have Received Allogeneic Bone Marrow Transplantation for Hematological Malignancies


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hematological Malignancies

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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.


Inclusion Criteria:



1. Age greater than or equal to 18 years.

2. Patients with the diagnosis of hematologic malignancies or hematological disorders,
who are immediately post- allogeneic bone marrow transplantation.

3. Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses
for 12 consecutive months), must be willing to use contraception.

4. Negative pregnancy test in premenopausal patients.

5. Patients with GVHD or infections can be entered only if they respond to treatment and
become controlled.

6. 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.

Exclusion Criteria:

1. Patients with documented relapsed malignancy or recurrence of the original
hematological disorder after the transplant, uncontrolled acute GVHD, or uncontrolled
infection.

2. Patients with hypocalcemia of less than 8.4 (corrected to account for the albumin
level).

3. Patients with hypercalcemia >12.2, due to a cause not related to their hematological
malignancy or hematological disorder (i.e. hyperparathyroidism, multiple myeloma).

4. Hypersensitivity to Ibandronate or other bisphosphonates.

5. Pre-existing osteoporosis, defined as a bone density T-score of -2.5 S.D. or less.

6. Renal insufficiency (calculated creatinine clearance < 30 ml/min).

7. Patients already on bisphosphonates (over the past two years), calcitonin, anabolic
steroids, or daily oral fluoride supplement.

8. Myeloma patients who have previously been on bisphosphonates over the past two years
and/or have active bone lesions.

9. If corrected calcium is above 10.3 and the iPTH is elevated or normal, the patient
will be excluded from the study.

10. Patients with a 25-hydroxyvitamin D concentration <20 ng/ml and evidence of
osteomalacia (low ionized calcium and elevated intact PTH).

11. Dental considerations: Patients with recent tooth extraction with signs of incomplete
healing or significant infection will be excluded.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent Reduction in Bone Mineral Density (BMD) of the lumbar spine, femoral neck, and total hip

Outcome Time Frame:

Baseline to 12 Months

Safety Issue:

No

Principal Investigator

Huifang Lu, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0960

NCT ID:

NCT00824993

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Hematological Malignancies
  • Blood Cancer
  • Calcium
  • Vitamin D
  • Ibandronate
  • Boniva
  • Hematological Malignancies
  • Bone Marrow Transplantation
  • BMT
  • Osteoporosis
  • Bone Loss
  • Allogeneic Bone Marrow Transplantation
  • Neoplasms
  • Osteoporosis
  • Hematologic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030