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Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Primary Purpose

Osteogenesis Imperfecta

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
risedronate sodium (Actonel)
Placebo
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteogenesis Imperfecta focused on measuring Primary disease: Osteogenesis Imperfecta

Eligibility Criteria

4 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: OI diagnosis increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures. Exclusion Criteria: Any bisphosphonate use within one year of enrollment

Sites / Locations

  • Miami Children's Hospital
  • University of Nebraska Medical Center, Children's Hospital
  • Hospital for Special Surgery
  • Wright State University BioMedical Imaging Laboratory and Miami Valley Hospital
  • Oregon Health & Science University
  • The Children's Hospital at Westmead
  • Princess Margaret Hospital for Children
  • Cliniques Universitaires Saint Luc
  • Pontificia Universidad Catolica de Chile
  • Osteocentrum, II. Interní klinika, Fakultní nemocnice Plzeň-Bory
  • Hospital for Children and Adolescents
  • Klinikum und Poliklinik für Kinderheilkunde der Universität zu Köln
  • 2nd Department of Pediatrics, Semmelwies University, Faculty of Medicine
  • Rheumatologic Rehabilitation Unit of the University of Verona
  • Zaklad Biochemii i Medycyny Doswiadczalnej (Biochemisty Dept, Institute "Monument-Children Health Centre"
  • Little Company of Mary Hospital
  • Hospital Sant Joan de Deu
  • Bristol Royal Hospital for Children,
  • Royal Hospital for Sick Children
  • Sheffield Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Daily

Risedronate Daily

Arm Description

placebo tablet, once a day for one year then for two years open label risedronate

risedronate tablet, once a day for one year then for two years open label risedronate once a day

Outcomes

Primary Outcome Measures

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.

Secondary Outcome Measures

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Percent Change From Baseline in Total Body BMD at Month 12, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Percent Change From Baseline in Total Body BMD at Month 24, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Percent Change From Baseline in Total Body BMD at Month 36, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population
Percent Change From Baseline in Total Body BMC at Month 12, ITT Population
Percent Change From Baseline in Total Body BMC at Month 24, ITT Population
Percent Change From Baseline in Total Body BMC at Month 36, ITT Population
Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population
Measured by DXA.
Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population
Measured by DXA.
Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population
Measured by DXA.
Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population
Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population
Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population
New Morphometric Vertebral Fracture at Month 12, ITT Population
Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.
New Morphometric Vertebral Fracture at Month 36, ITT Population
Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.
Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT
Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.
Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT
Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.
Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population
Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population
Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population
Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Number of Clinical Fractures, Month 12, ITT Population
Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Serum BAP - Percent Change From Baseline to Month 12, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Serum BAP - Percent Change From Baseline to Month 24, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Serum BAP - Percent Change From Baseline to Month 36, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population
Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al.
Bone Age (Years), Change From Baseline to Month 12, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Bone Age (Years), Change From Baseline to Month 24, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Bone Age (Years), Change From Baseline to Month 36, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population
Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]
Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population
Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]

Full Information

First Posted
March 18, 2005
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00106028
Brief Title
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Official Title
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
Keywords
Primary disease: Osteogenesis Imperfecta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Daily
Arm Type
Placebo Comparator
Arm Description
placebo tablet, once a day for one year then for two years open label risedronate
Arm Title
Risedronate Daily
Arm Type
Experimental
Arm Description
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Intervention Type
Drug
Intervention Name(s)
risedronate sodium (Actonel)
Intervention Description
risedronate tablet once a day for one year followed by risedronate once a day for two years
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablet once a day for one year followed by risedronate once a day for two years
Primary Outcome Measure Information:
Title
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
Description
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.
Time Frame
Baseline and Month 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population
Description
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Time Frame
Baseline and Month 24
Title
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population
Description
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Time Frame
Baseline and Month 36
Title
Percent Change From Baseline in Total Body BMD at Month 12, ITT Population
Description
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time Frame
Baseline and Month 12
Title
Percent Change From Baseline in Total Body BMD at Month 24, ITT Population
Description
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time Frame
Baseline and Month 24
Title
Percent Change From Baseline in Total Body BMD at Month 36, ITT Population
Description
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time Frame
Baseline and Month 36
Title
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population
Time Frame
Baseline and Month 12
Title
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population
Time Frame
Baseline and Month 24
Title
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population
Time Frame
Baseline and Month 36
Title
Percent Change From Baseline in Total Body BMC at Month 12, ITT Population
Time Frame
Baseline and Month 12
Title
Percent Change From Baseline in Total Body BMC at Month 24, ITT Population
Time Frame
Baseline and Month 24
Title
Percent Change From Baseline in Total Body BMC at Month 36, ITT Population
Time Frame
Baseline and Month 36
Title
Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population
Description
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame
Baseline and Month 12
Title
Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population
Description
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame
Baseline and Month 24
Title
Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population
Description
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame
Baseline and Month 36
Title
Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population
Description
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame
Baseline and Month 12
Title
Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population
Description
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame
Baseline and Month 24
Title
Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population
Description
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame
Baseline and Month 36
Title
Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population
Description
Measured by DXA.
Time Frame
Baseline and Month 12
Title
Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population
Description
Measured by DXA.
Time Frame
Baseline and Month 24
Title
Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population
Description
Measured by DXA.
Time Frame
Baseline and Month 36
Title
Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population
Time Frame
Baseline and Month 12
Title
Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population
Time Frame
Baseline and Month 24
Title
Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population
Time Frame
Baseline and Month 36
Title
New Morphometric Vertebral Fracture at Month 12, ITT Population
Description
Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.
Time Frame
Baseline and Month 12
Title
New Morphometric Vertebral Fracture at Month 36, ITT Population
Description
Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.
Time Frame
Baseline and Month 36
Title
Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT
Description
Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.
Time Frame
Baseline and Month 12
Title
Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT
Description
Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.
Time Frame
Baseline and Month 36
Title
Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population
Description
Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Time Frame
Month 12
Title
Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population
Description
Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Time Frame
Month 12
Title
Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population
Description
Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Time Frame
Time to First Event (days) up to 12 Months
Title
Number of Clinical Fractures, Month 12, ITT Population
Description
Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Time Frame
12 Months
Title
Serum BAP - Percent Change From Baseline to Month 12, ITT Population
Description
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time Frame
Baseline and 12 Months
Title
Serum BAP - Percent Change From Baseline to Month 24, ITT Population
Description
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time Frame
Baseline and 24 Months
Title
Serum BAP - Percent Change From Baseline to Month 36, ITT Population
Description
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time Frame
Baseline and 36 Months
Title
Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population
Description
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time Frame
Baseline and Endpoint / Month 12
Title
Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population
Description
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time Frame
Baseline and Month 24
Title
Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population
Description
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time Frame
Baseline and Month 36
Title
Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population
Description
Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al.
Time Frame
Baseline and Month 12
Title
Bone Age (Years), Change From Baseline to Month 12, ITT Population
Description
Bone Age determined by visual assessment of hand / wrist radiographs.
Time Frame
Baseline and Month 12
Title
Bone Age (Years), Change From Baseline to Month 24, ITT Population
Description
Bone Age determined by visual assessment of hand / wrist radiographs.
Time Frame
Baseline and Month 24
Title
Bone Age (Years), Change From Baseline to Month 36, ITT Population
Description
Bone Age determined by visual assessment of hand / wrist radiographs.
Time Frame
Baseline and Month 36
Title
Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population
Description
Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]
Time Frame
Baseline and Month 12
Title
Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population
Description
Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]
Time Frame
Baseline and Month 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: OI diagnosis increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures. Exclusion Criteria: Any bisphosphonate use within one year of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietrich H Wenderoth, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
University of Nebraska Medical Center, Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Wright State University BioMedical Imaging Laboratory and Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
Country
Australia
Facility Name
Cliniques Universitaires Saint Luc
City
Bruxelles
Country
Belgium
Facility Name
Pontificia Universidad Catolica de Chile
City
Santiago
Country
Chile
Facility Name
Osteocentrum, II. Interní klinika, Fakultní nemocnice Plzeň-Bory
City
Plzen
Country
Czech Republic
Facility Name
Hospital for Children and Adolescents
City
Helsinki
Country
Finland
Facility Name
Klinikum und Poliklinik für Kinderheilkunde der Universität zu Köln
City
Koln
Country
Germany
Facility Name
2nd Department of Pediatrics, Semmelwies University, Faculty of Medicine
City
Budapest
Country
Hungary
Facility Name
Rheumatologic Rehabilitation Unit of the University of Verona
City
Valeggio sul Mincio
Country
Italy
Facility Name
Zaklad Biochemii i Medycyny Doswiadczalnej (Biochemisty Dept, Institute "Monument-Children Health Centre"
City
Warzawa-Międzylesie
Country
Poland
Facility Name
Little Company of Mary Hospital
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Hospital Sant Joan de Deu
City
Barcelona
Country
Spain
Facility Name
Bristol Royal Hospital for Children,
City
Bristol
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Sheffield Children's Hospital
City
Sheffield
ZIP/Postal Code
S210 2TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23927913
Citation
Bishop N, Adami S, Ahmed SF, Anton J, Arundel P, Burren CP, Devogelaer JP, Hangartner T, Hosszu E, Lane JM, Lorenc R, Makitie O, Munns CF, Paredes A, Pavlov H, Plotkin H, Raggio CL, Reyes ML, Schoenau E, Semler O, Sillence DO, Steiner RD. Risedronate in children with osteogenesis imperfecta: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Oct 26;382(9902):1424-32. doi: 10.1016/S0140-6736(13)61091-0. Epub 2013 Aug 6.
Results Reference
derived

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Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

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