Phase 3
N=78
Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients
Hematological Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT00824993 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months — 0.06; -2.61; -3.63; -4.85 Percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ibandronate (Drug); Vitamin Supplements (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months |
0.06; -2.61; -3.63; -4.85; -2.73; -4.72 | — |
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. 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.
2. 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:
1. Primary Objective:
1. 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.
2. Secondary Objectives:
1. To measure and compare the accumulated level of steroid used in both treatment and control groups.
2. 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.
3. To conduct a cost-effectiveness analysis of participating patients for both outcomes on bone mineral density (measured data) and skeletal-related events (modeled data).
4. To record incidence of bone fractures and the graft rate in both treatment and control groups.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00824993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.