The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

Condition	Treatment or Intervention	Phase
Osteogenesis Imperfecta	Drug: Zoledronic Acid	Phase II

Children with severe osteogenesis imperfecta (OI) suffer recurrent fractures resulting in deformity, bone pain and stunted growth. These patients would have much to gain from the development of a safe and effective treatment for OI.

Ages Eligible for Study:  3 Months   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion

• Male or Female children between 3 months and 17 years old
• OI type I, III or IV

Exclusion

• Deformity or abnormality which would prevent spine bone density from being done
• Any surgical bone-lengthening procedure
• Any kidney diseases or abnormalities
• Low calcium or vitamin D levels in the blood

California
      UCLA - Division of Pediatric Nephrology, Los Angeles,  California,  90024,  United States; Recruiting
Colorado
      The Children's Hospital, Denver,  Colorado,  80128,  United States; Recruiting
Delaware
      Alfred I. DuPont Hospital for Children, Wilmington,  Delaware,  19899,  United States; Recruiting
Idaho
      Intermountain Orthopedics, Boise,  Idaho,  83702,  United States; Recruiting
Illinois
      St. Jude Children's Research Hospital, Peoria,  Illinois,  61637,  United States; Recruiting
Nebraska
      Children's Hosptial, Omaha,  Nebraska,  68198,  United States; Recruiting
Ohio
      Children's Hospital Medical Center, Cincinnati,  Ohio,  45229,  United States; Recruiting
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201,  United States; Recruiting
Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232,  United States; Recruiting
Texas
      Texas Children's Hosptial, Houston,  Texas,  77030,  United States; Recruiting

Study ID Numbers:  CZOL446H2202
Record last reviewed:  November 2003
Record first received:  June 27, 2003
ClinicalTrials.gov Identifier:  NCT00063479
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29