Search / Trial NCT00001720

Treatment of Childhood Osteoporosis With Alendronate (Fosamax)

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Nov 3, 1999

Trial Information

Current as of December 26, 2024

Completed

Keywords

Glucocorticoids Bone Mineral Density Bisphosphonates Vertebral Fracture Childhood Osteoporosis

ClinConnect Summary

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...

Gender

ALL

Eligibility 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.

About Eunice Kennedy Shriver National Institute Of Child Health And Human Development (Nichd)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is a prominent research agency within the National Institutes of Health (NIH), dedicated to advancing the health and well-being of children, families, and individuals across the lifespan. NICHD supports a wide range of clinical trials and research initiatives aimed at understanding the complex biological, behavioral, and environmental factors that influence human development and health. By fostering innovative research and facilitating collaboration among scientists, healthcare professionals, and communities, NICHD plays a vital role in translating scientific discoveries into effective interventions and policies that enhance child health, reproductive health, and the prevention of diseases.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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