Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00259857 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis

A Phase 2 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT00259857: Completed Phase 2 study, sponsored by Medical University of South Carolina.

NCT00259857 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00259857, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.

Primary Outcome

Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.

Interventions

  • DRUG Alendronate

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2003-10
Est. Completion 2009-08
Phase Phase 2

What the finished NCT00259857 record still lists

NCT00259857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Alendronate is the first listed.

NCT00259857 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00259857 about?

NCT00259857 is a clinical study titled "Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis". We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The...

What is the current status of trial NCT00259857?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2003-10. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00259857?

The interventions under investigation include: Alendronate (DRUG).

Who is sponsoring clinical trial NCT00259857?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00259857's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02508038 · 22 participants · Phase 1

    Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors

  • NCT03099356 · 22 participants · Phase 2

    Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer

  • NCT03676647 · 22 participants

    Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules

  • NCT04569591 · 22 participants · NA

    DDAVP for Pituitary Adenoma

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00259857, the US trial registry maintained by the National Library of Medicine. NCT00259857 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.