## Protocol Section
### Identification Module
**NCT ID:** NCT00063479

**Brief Title:** Bisphosphonate Treatment of Osteogenesis Imperfecta

**Official Title:** Bisphosphonate Treatment of Osteogenesis Imperfecta

#### Organization Study ID Info
**ID:** CZOL446H2202
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2007-05

**Type:** ACTUAL

#### Last Update Post Date
**Date:** 2017-06-01

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-05

**Type:** ACTUAL

#### Start Date
**Date:** 2003-06

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2003-06-30
**Type:** ESTIMATED
**Study First Submit Date:** 2003-06-27
**Study First Submit QC Date:** 2003-06-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Pharmaceuticals

### 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.

### Conditions Module

**Conditions:**

- Osteogenesis Imperfecta

**Keywords:**

- Osteogenesis Imperfecta

- OI

- bone markers

- fracture

- bone loss

- pediatric

- bisphosphonate

- brittle bone disease

- pamidronate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 158

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Zoledronic Acid

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

#### Secondary Outcomes

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

### 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.

**Maximum Age:** 17 Years

**Minimum Age:** 3 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** UCLA - Division of Pediatric Nephrology

**State:** California

**Zip:** 90024

**Location 2:**

**City:** Wilmington

**Country:** United States

**Facility:** Alfred I. DuPont Hospital for Children

**State:** Delaware

**Zip:** 19899

**Location 3:**

**City:** Boise

**Country:** United States

**Facility:** Intermountain Orthopedics

**State:** Idaho

**Zip:** 83702

**Location 4:**

**City:** Peoria

**Country:** United States

**Facility:** St. Jude Children's Research Hospital

**State:** Illinois

**Zip:** 61637

**Location 5:**

**City:** Omaha

**Country:** United States

**Facility:** Children's Hospital

**State:** Nebraska

**Zip:** 68198

**Location 6:**

**City:** Cincinnati

**Country:** United States

**Facility:** Children's Hospital Medical Center

**State:** Ohio

**Zip:** 45229

**Location 7:**

**City:** Columbus

**Country:** United States

**Facility:** Children's Hospital

**State:** Ohio

**Zip:** 43205

**Location 8:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Health Sciences University

**State:** Oregon

**Zip:** 97201

**Location 9:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt University Medical Center

**State:** Tennessee

**Zip:** 37232

**Location 10:**

**City:** Houston

**Country:** United States

**Facility:** Texas Children's Hosptial

**State:** Texas

**Zip:** 77030

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010009

- Term: Osteochondrodysplasias

- ID: D000001848

- Term: Bone Diseases, Developmental

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000003095

- Term: Collagen Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12936

- Name: Osteogenesis Imperfecta

- Relevance: HIGH

- As Found: Osteogenesis Imperfecta

- ID: M12932

- Name: Osteochondrodysplasias

- Relevance: LOW

- As Found: Unknown

- ID: M12043

- Name: Mucopolysaccharidosis IV

- Relevance: LOW

- As Found: Unknown

- ID: M5127

- Name: Bone Diseases, Developmental

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4306

- Name: Osteogenesis Imperfecta

- Relevance: HIGH

- As Found: Osteogenesis Imperfecta

- ID: T3909

- Name: Mucopolysaccharidosis Type IV

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010013

- Term: Osteogenesis Imperfecta

### Intervention Browse Module - Ancestors

- ID: D000050071

- Term: Bone Density Conservation Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1699

- Name: Zoledronic Acid

- Relevance: HIGH

- As Found: Lymphoblastic

- ID: M7346

- Name: Diphosphonates

- Relevance: LOW

- As Found: Unknown

- ID: M1724

- Name: Pamidronate

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077211

- Term: Zoledronic Acid

### Misc Info Module

#### Removed Countries

- Country: Germany

- Version Holder: 2024-05-24
