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Bisphosphonate Treatment of Osteogenesis Imperfecta

Primary Purpose

Osteogenesis Imperfecta

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteogenesis Imperfecta focused on measuring Osteogenesis Imperfecta, OI, bone markers, fracture, bone loss, pediatric, bisphosphonate, brittle bone disease, pamidronate

Eligibility Criteria

3 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • UCLA - Division of Pediatric Nephrology
  • Alfred I. DuPont Hospital for Children
  • Intermountain Orthopedics
  • St. Jude Children's Research Hospital
  • Children's Hospital
  • Children's Hospital Medical Center
  • Children's Hospital
  • Oregon Health Sciences University
  • Vanderbilt University Medical Center
  • Texas Children's Hosptial

Outcomes

Primary Outcome Measures

Change in lumbar spine bone mineral density at month 12 relative to baseline

Secondary Outcome Measures

Change in Z score of the lumbar spine at month 12 relative to baseline

Full Information

First Posted
June 27, 2003
Last Updated
May 31, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00063479
Brief Title
Bisphosphonate Treatment of Osteogenesis Imperfecta
Official Title
Bisphosphonate Treatment of Osteogenesis Imperfecta
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
Keywords
Osteogenesis Imperfecta, OI, bone markers, fracture, bone loss, pediatric, bisphosphonate, brittle bone disease, pamidronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Primary Outcome Measure Information:
Title
Change in lumbar spine bone mineral density at month 12 relative to baseline
Secondary Outcome Measure Information:
Title
Change in Z score of the lumbar spine at month 12 relative to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
UCLA - Division of Pediatric Nephrology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Alfred I. DuPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Intermountain Orthopedics
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Children's Hosptial
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bisphosphonate Treatment of Osteogenesis Imperfecta

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