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NCT00921557 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT00921557 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 52 participants.
The verdict
NCT00921557, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U.S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study was to compare changes from pre-treatment levels of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in HIV-infected children and adolescents.
Interventions
- DRUG Placebo
- DRUG Alendronate
- DIETARY_SUPPLEMENT Calcium carbonate/vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2009-11 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00921557
The ClinicalTrials.gov registry entry for NCT00921557 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00921557 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00921557 about?
NCT00921557 is a clinical study titled "Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents". HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U.S. children are entering or in adolescence, the potential for HIV-related impaired BMD during...
What is the current status of trial NCT00921557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2009-11. Estimated completion is 2017-01.
What interventions are being tested in trial NCT00921557?
The interventions under investigation include: Placebo (DRUG), Alendronate (DRUG), Calcium carbonate/vitamin D (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00921557?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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