Bisphosphonate Treatment of Osteogenesis Imperfecta | NCT00063479

Studies
Bisphosphonate Treatment of Osteogenesis Imperfecta

NCT00063479

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Jun 1, 2017Actual

Enrollment

158

Phase

Phase 2

Conditions

Osteogenesis Imperfecta

Interventions

Zoledronic Acid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2003

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Jun 27, 2003

First Submission Date that Met QC Criteria

Jun 27, 2003

First Posted Date

Jun 30, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2017

Last Update Posted Date

Jun 1, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

158

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic Acid	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in lumbar spine bone mineral density at month 12 relative to baseline

Secondary Outcomes

Measure	Description	Time Frame
Change in Z score of the lumbar spine at month 12 relative to baseline

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA - Division of Pediatric Nephrology		Los Angeles	California	90024	United States
Alfred I. DuPont Hospital for Children

Condition Browse Module

MeSH Terms

ID	Term
D010013	Osteogenesis Imperfecta
D050723	Fractures, Bone
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D010009	Osteochondrodysplasias
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077211	Zoledronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided