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Bisphosphonate Treatment of Osteogenesis Imperfecta



Bisphosphonate Treatment of Osteogenesis Imperfecta

For Condition: Osteogenesis Imperfecta
Status: Recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 3 Months/17 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 138

Location and Contact Information:

St. Jude Children's Research Hospital *Recruiting*
Peoria,  Illinois,  61637
United States
Recruiting Kathy  Kissel 309-624-4945

UCLA - Division of Pediatric Nephrology *Recruiting*
Los Angeles,  California,  90024
United States
Recruiting Janet  Mooney 310-794-8785

Intermountain Orthopedics *Recruiting*
Boise,  Idaho,  83702
United States
Recruiting Jackie  Thomason 208-489-4295

Vanderbilt University Medical Center *Recruiting*
Nashville,  Tennessee,  37232
United States
Recruiting Karen  Adkins 615-322-2742

The Children's Hospital *Recruiting*
Denver,  Colorado,  80128
United States
Recruiting Hazel  Senz 303-764-8430

Alfred I. DuPont Hospital for Children *Recruiting*
Wilmington,  Delaware,  19899
United States
Recruiting Sandra  Budd 302-651-6536

Oregon Health Sciences University *Recruiting*
Portland,  Oregon,  97201
United States
Recruiting Jennifer  Penfield 503-494-7944

Texas Children's Hosptial *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Susan  Carter 832-822-1630

Children's Hosptial *Recruiting*
Omaha,  Nebraska,  68198
United States
Recruiting Kathy  Rossiter 402-559-4056

Children's Hospital Medical Center *Recruiting*
Cincinnati,  Ohio,  45229
United States
Recruiting Leah  Hoechstetter 513-636-4351


Additional Information:
Study ID Numbers:
  CZOL446H2202; 
Study Start Date: June 2003
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063479

Other Osteogenesis Imperfecta Studies:
1. Evaluation and Intervention for the Effects of Osteogenesis Imperfecta

2. Growth Hormone Therapy in Osteogenesis Imperfecta

3. Pamidronate to Treat Osteogenesis Imperfecta in Children

4. Bisphosphonate Treatment of Osteogenesis Imperfecta

Related Studies:

Other Osteogenesis Imperfecta Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials

Bisphosphonate Treatment of Osteogenesis Imperfecta

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