CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Alendronatedrug
Likely dose
Alendronate 35mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00259857
NCT00259857Phase 2Completed
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A Randomized, Double-Blind, Placebo-Controlled, Prospective, Cross-Over Phase II Clinical Trial to Determine the Safety and Efficacy of Alendronate (Fosamax) in Juvenile Osteoporosis (IND#60,017)

Medical University of South Carolina·interventional·Posted Dec 1, 2005·Updated Jan 19, 2011

In Brief

A Phase 2 clinical trial evaluating Alendronate for Osteoporosis. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
CollaboratorsFDA Office of Orphan Products Development, Merck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 1, 2005
Enrollment StartOct 1, 2003
Primary CompletionMar 1, 2008
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.6 years ago

Interventions

Alendronatedrug

Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.