Treatment of Childhood Osteoporosis With Alendronate (Fosamax)
Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)