Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT00824993
Eligibility Criteria:
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 immunoreactive parathyroid hormone (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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00824993
Study Brief:
Protocol Section:
NCT00824993