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NCT00352846 · ClinicalTrials.gov registry record · Phase 3
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
A Phase 3 study of Lymphoma and Non-Hodgkin's Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
- 1
- Study location
NCT00352846: Completed Phase 3 study of Lymphoma and Non-Hodgkin's Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT00352846 is a Phase 3 study of Lymphoma and Non-Hodgkin's Lymphoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 135 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00352846, a Phase 3 study of Lymphoma and Non-Hodgkin's Lymphoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: * Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck. Secondary Objectives: * Evaluate the effect of zoledronate on change in BMD at the total hip * Evaluate risk factors for developing osteoporosis on chemotherapy * Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).
Primary Outcome
The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score \>= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores \<= -2.5 indicate osteoporosis.
Conditions Studied
Interventions
- DRUG Zoledronic Acid
- DRUG Vitamin D
- DRUG Calcium Carbonate
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2006-01 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
What the finished NCT00352846 record still lists
NCT00352846 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Zoledronic Acid is the first listed.
NCT00352846 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00352846 about?
NCT00352846 is a clinical study titled "Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss". Primary Objective: * Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck. Secondary Objectives: * Evaluate the effect of zoledronate on change in BMD at the total hip * Evaluate risk factors for developing osteoporosis on chemother...
What is the current status of trial NCT00352846?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2006-01. Estimated completion is 2011-09.
What conditions does trial NCT00352846 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT00352846?
The interventions under investigation include: Zoledronic Acid (DRUG), Vitamin D (DRUG), Calcium Carbonate (DRUG).
Who is sponsoring clinical trial NCT00352846?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00352846 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00352846's enrollment target sits among peer trials
135 65th of 299 higher than 235 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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