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NICHD
NIH
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Treatment
of Childhood Osteoporosis with Alendronate (Fosamax)
This
study is currently recruiting patients.
Purpose
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.
Condition |
Treatment or Intervention
|
Phase |
Osteoporosis
|
Drug: Alendronate |
Phase
II |
MEDLINEplus
related topics: Osteoporosis
Study
Type: Interventional
Official Title: Alendronate
versus Placebo for Idiopathic Juvenile Osteoporosis
Further
Study Details:
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
fractures.
Eligibility
Genders Eligible for Study: Both
Criteria
INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- 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...).
- Hypocalcemia.
- 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.
Expected
Total Enrollment:50
Location
and Contact Information
National
Institute of Child Health and Human Development (NICHD), 9000 Rockville
Pike Bethesda, Maryland, 20892, United States;Recruiting
Patient Recruitment and Public Liaison Office 1-800-411-1222 prpl@mail.cc.nih.gov TTY
1-866-411-1010
Publications
Bachrach
LK. Bone mineralization in childhood and adolescence. Curr Opin Pediatr.
1993 Aug;5(4):467-73. Review.
Brumsen
C, Hamdy NA, Papapoulos SE. Long-term effects of bisphosphonates on
the growing skeleton. Studies of young patients with severe osteoporosis.
Medicine (Baltimore). 1997 Jul;76(4):266-83. Review.
Falcini
F, Trapani S, Ermini M, Brandi ML. Intravenous administration of alendronate
counteracts the in vivo effects of glucocorticoids on bone remodeling.
Calcif Tissue Int. 1996 Mar;58(3):166-9.
Study ID Numbers 980077; 98-CH-0077
Date study started March 17, 1998
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