Not Signed In -
Osteogenesis Imperfecta |
Brittle bone disease; Ekman-Lobstein disease; Fragilitas ossium; OI; Osteopsathyrosis; Vrolik disease |
Clinical Trial: Bisphosphonate Treatment of Osteogenesis Imperfecta
This study is currently recruiting patients.
|
Purpose
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 |
MedlinePlus related topics: Osteogenesis Imperfecta
Genetics Home Reference related topics: osteogenesis imperfecta
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Further Study Details:
Study start: June 2003
Eligibility
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
Location and Contact Information
California
UCLA - Division of Pediatric Nephrology, Los Angeles, California, 90024, United States; Recruiting
Janet Mooney 310-794-8785
Delaware
Alfred I. DuPont Hospital for Children, Wilmington, Delaware, 19899, United States; Recruiting
Sandra Budd 302-651-6536
Stacy Koletty 302-651-6548
Stacy Koletty 302-651-6548
Idaho
Intermountain Orthopedics, Boise, Idaho, 83702, United States; Recruiting
Jackie Thomason 208-489-4295
Illinois
St. Jude Children's Research Hospital, Peoria, Illinois, 61637, United States; Recruiting
Kathy Kissel 309-624-4945
Nebraska
Children's Hosptial, Omaha, Nebraska, 68198, United States; Recruiting
Kathy Rossiter 402-559-4056
New Jersey
For information regarding facilities outside of the United States, contact Monique Tan, E. Hanover, New Jersey, 07936, United States; Recruiting
Monique Tan 862-778-6683 monique.tan@pharma.novartis.com
Ohio
Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States; Recruiting
Leah Hoechstetter 513-636-4351
Children's Hospital, Columbus, Ohio, 43205, United States; Recruiting
Kathy Cassandra 614-722-4360
Oregon
Oregon Health Sciences University, Portland, Oregon, 97201, United States; Recruiting
Jennifer Penfield 503-494-7944
Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States; Recruiting
Karen Adkins 615-322-2742
Texas
Texas Children's Hosptial, Houston, Texas, 77030, United States; Recruiting
Susan Carter 832-822-1630
More Information
Study ID Numbers: CZOL446H2202
Record last reviewed: December 2004
Last Updated: January 3, 2005
Record first received: June 27, 2003
ClinicalTrials.gov Identifier: NCT00063479
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: December 2004
Last Updated: January 3, 2005
Record first received: June 27, 2003
ClinicalTrials.gov Identifier: NCT00063479
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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