CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed
Drug / intervention
Alendronatedrug
Likely dose
Not stated in record
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Search/NCT00001720
NCT00001720Phase 2Completed

Alendronate Versus Placebo for Idiopathic Juvenile Osteoporosis

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Nov 4, 1999·Updated Sep 22, 2016

In Brief

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

Detailed Summary

Bones grow and stay strong through a continuous process of formation (building) and resorption (break down). When more bone is formed than resorbed, the density (level of calcium) in bone increases and the bones become stronger. However, if more bone is resorbed than formed the density of bone decreases and the bones become weak. This condition is called osteoporosis. Osteoporosis is a rare but serious condition in children. Childhood osteoporosis can occur without a known cause (idiopathic juvenile osteoporosis). Children with osteoporosis suffer from pain, inability to stay active, and increased amounts of broken bones, including fractures of the spine. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a less than normal bone composition (peak bone mass) during the first 20-30 years of life may be at an increased risk for osteoporosis as adults. Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down). It has been used to treat post-menopausal osteoporosis, male osteoporosis and adults with osteoporosis due to long-term steroid therapy. The goal of this study is to determine the effectiveness of alendronate in children with idiopathic juvenile osteoporosis. Researchers believe that children treated with alendronate will improve bone strength and decrease the amount of fractures caused by osteoporosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartMar 1, 1998
Study CompletionJun 1, 2003
TodayJul 2, 2026
Posted 26.7 years ago

Interventions

Alendronatedrug