Status:
COMPLETED
Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 s...
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 re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
December 9 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2017
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00824993
Start Date
December 9 2008
End Date
April 7 2017
Last Update
September 13 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030