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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline \* 100%. Results for Groups 1A and 1B combined as both were on alendronate for the first 48 weeks.
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 |
What the finished NCT00921557 record still lists
NCT00921557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00921557 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00921557's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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