Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Osteoporosis
In brief
We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.
Key facts
- Study ID
- NCT00259857
- Run by
- Medical University of South Carolina
- People needed
- 22
- Starts
- 2003-10-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2011-01-19
Who can join
Age: 5 and older, up to 15. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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