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NCT00824993 · ClinicalTrials.gov registry record · Phase 3
Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 78
- Enrollment target
NCT00824993: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00824993 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 78 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00824993, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 78 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline.
Interventions
- DRUG Ibandronate
- DRUG Vitamin Supplements
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2008-12-09 |
| Est. Completion | 2017-04-07 |
| Phase | Phase 3 |
What the finished NCT00824993 record still lists
NCT00824993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibandronate is the first listed.
NCT00824993 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00824993 about?
NCT00824993 is a clinical study titled "Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients". 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 immediatel...
What is the current status of trial NCT00824993?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 78 participants. The study started on 2008-12-09. Estimated completion is 2017-04-07.
What interventions are being tested in trial NCT00824993?
The interventions under investigation include: Ibandronate (DRUG), Vitamin Supplements (DRUG).
Who is sponsoring clinical trial NCT00824993?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00824993's enrollment target sits among peer trials
78 1769th of 2000 higher than 230 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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