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:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT00259857
Eligibility Criteria:
Eligibility Criteria:
* 5-15 yrs of age
* Weighing 20 kg and more
* History of multiple fractures
* Tanner stage II or less
* Osteoporosis by DXA.
Inclusion Criteria:
* Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of \>20 percent).
* Bone Mineral Density (BMD) determined by DXA sacn to confirm osteoporosis at a Z score greater than 2 SD (standard deviations) below the normal mean for age (Z score \< -2 SD).
* Parental consent (and patient assent after age 12 years) to participate in the study.
* Sexual development at: Tanner stage II or less (Prepubertal stage).
* Weight = 20 kg and more.
Exclusion Criteria:
* History of severe gastritis or reflux.
* Abnormalities of the esophagus that delay emptying, such as strictures or achalasia
* Marked kyphoscoliosis or the inability to sit or stand for at least 30 minutes
* Hypersensitivity to bisphosphonates
* Uncorrected hypocalcemia
* History of gastric or duodenal ulcers
* Renal dysfunction as indicated by serum Cr \>1.5 mg/dl.
* Liver dysfunction as indicated by serum SGPT \> 2 times the upper limit for age or serum total bilirubin \> 2.0 mg/dl.
* Diagnosis of osteogenesis imperfecta, a family history of osteogenesis imperfecta, blue sclerae or deafness.
* Diagnosis of active rickets or osteomalacia or serum bone alkaline phosphatase 2 times greater than normal for age.
* Pregnancy
* Anorexia Nervosa
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
15 Years
Study:
NCT00259857
Study Brief:
Protocol Section:
NCT00259857