Status:
COMPLETED
Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
FDA Office of Orphan Products Development
Merck Sharp & Dohme LLC
Conditions:
Osteoporosis
Eligibility:
All Genders
5-15 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Osteoporosis is an uncommon disease in children and early adolescents. Patients have a low bone mineral density, develop fractures with minimal or no trauma, and frequently have a negative family hist...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- 5-15 yrs of age
- Weighing 20 kg and more
- History of multiple fractures
- Tanner stage II or less
- Osteoporosis by DXA.
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00259857
Start Date
October 1 2003
End Date
August 1 2009
Last Update
January 19 2011
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425