Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00001720
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001720
Study Brief:
Protocol Section:
NCT00001720