Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: FDA Office of Orphan Products Development; Merck Sharp & Dohme Corp.
• Treatments: Alendronate; Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

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