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

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Glucocorticoids Bone Mineral Density Bisphosphonates Vertebral Fracture Childhood Osteoporosis

Description

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.

Attachments

readout_NCT00001720_2024-06-13.pdf

4.5 MB

NCT00001720_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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