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NCT00186901 · ClinicalTrials.gov registry record · Phase 3
A Severity-Adapted Clinical Trial of Diminished Bone Mineral Density in Acute Lymphoblastic Leukemia Survivors
A Phase 3 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 429
- Enrollment target
NCT00186901 is a Phase 3 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 429 participants.
The verdict
NCT00186901, a Phase 3 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 429 participants
- Enrollment target
Study Summary
Research studies have shown that children who are long-term survivors of childhood leukemia may be at greater risk for early bone loss called osteoporosis. This bone loss may lead to a greater risk of broken bones and other spine and bone problems. However, researchers still do not know much about how frequently this long-term side effect may occur and how severe the problem is. St. Jude Children's Research Hospital researchers want to determine the frequency and severity of this side effect. They are also studying whether taking calcium and Vitamin D supplements can help children at risk for osteoporosis and if certain factors can be identified -- such as age at diagnosis, cancer treatments, or family history -- that may increase the chances of having osteoporosis. Researchers will take an x-ray study called quantitative computed tomography (QCT) to measure bone mineral density (BMD). The BMD is a measure of bone strength. If a subject's BMD falls below the average, he/she will be assigned to one of two groups. Subjects will be randomly assigned (like tossing a coin) to receive calcium and vitamin D pills. The other half will receive placebo pills that look like the calcium and vitamin D pills.
Interventions
- OTHER Placebo
- DRUG Calcium carbonate (Tums), vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 429 participants |
| Start Date | 2000-07 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00186901
The ClinicalTrials.gov registry entry for NCT00186901 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 429 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00186901 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00186901 about?
NCT00186901 is a clinical study titled "A Severity-Adapted Clinical Trial of Diminished Bone Mineral Density in Acute Lymphoblastic Leukemia Survivors". Research studies have shown that children who are long-term survivors of childhood leukemia may be at greater risk for early bone loss called osteoporosis. This bone loss may lead to a greater risk of broken bones and other spine and bone problems. However, researchers still do not know much about h...
What is the current status of trial NCT00186901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 429 participants. The study started on 2000-07. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00186901?
The interventions under investigation include: Placebo (OTHER), Calcium carbonate (Tums), vitamin D (DRUG).
Who is sponsoring clinical trial NCT00186901?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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