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
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.
Osteoporosis is a rare but serious condition in children. One of the least well understood
forms of childhood osteoporosis is idiopathic juvenile osteoporosis. Affected children
suffer from pain, decreased activity tolerance, and increased fractures, including vertebral
compression fractures. Even mild childhood osteoporosis may have long-term consequences
since individuals who achieve a lower peak bone mass during the first 2-3 decades of life
may be at increased risk for osteoporosis as adults.
Alendronate (Fosamax (Trademark), Merck & Co.), an aminobisphosphonate, is a potent
inhibitor of bone resorption. It has been used to treat postmenopausal osteoporosis,
idiopathic male osteoporosis, and glucocorticoid induced osteoporosis in adults. The goal of
this protocol is to evaluate the effectiveness of Alendronate in children with
glucocorticoid induced and idiopathic juvenile osteoporosis using a double-blind,
randomized, placebo-controlled study design. We hypothesize that children treated with this
drug will have an improvement in bone mineral density and decrease in osteoporotic
Chronological age: 6.0 - 17.0 years. Study population will be restricted to children
greater than 12 years of age until 8 patients have completed 6 months of the study or
safety data is available from a comparable study.
AP Lumbar spine bone mineral density less than or equal to -2 standard deviations for age
matched controls (z-score) using Hologic QDR machine.
Normative data published by Faulkner will be used to calculate Z-scores.
Patients with Idiopathic Juvenile Osteoporosis, osteoporosis (BMD less than -2 SD compared
to age-matched controls) in a child with no identifiable etiology. Children with IJO and
delayed puberty will have their z-score calculated on the basis of bone age.
Inability to swallow pills or comply with administration instructions.
Upper gastrointestinal tract disease.
Creatinine clearance greater than or equal to 35 mL per min per 1.73 square meters.
Prior treatment with bisphosphonates.
Concurrent therapy with oral aspirin or salicylate containing compounds, excluding
delayed-release salicylates which act in the distal gastrointestinal tract (for example,
mesalamine, sulfasalazine, etc...).
Treatment with hGH or calcitonin in the preceding 6 months.
Inability to undergo dual energy x-ray absorptiometry.
Positive pregnancy test.
In females, sexual activity without an effective method of contraception.