Back to resultsEfficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta
Primary Purpose
Osteogenesis Imperfecta
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteogenesis Imperfecta
Eligibility Criteria
Inclusion Criteria:
- children or adolescents aged 0-18 years,
- had either a history of at least once minor-impact fracture or age and sex adjusted areal BMD Z score of -1.0 or less at lumbar spine or total hip;
- with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta;
- with or without slim long bone; with or without cranial epactal bones, signs of multiple fractures, bony deformity in skeletal X-ray films.
Exclusion Criteria:
- previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism;
- therapy history of BPs within recent two years; severe renal failure (creatinine clearance <40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract;
- unable to keep upright for at least 30 minutes daily .
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
an open label, prospective, self-controlled study
Arm Description
Children or adolescents under the age of 18 years old with minor trauma fracture were recruited from 30 provinces of China. The diagnosis of OI was made by endocrinology department of Peking Union Medical College Hospital(PUMCH).
Outcomes
Primary Outcome Measures
changes from baseline of areal BMD at lumbar spine and total hip
annual clinical fracture incidence
Secondary Outcome Measures
changes of bone turnover biomarkers
changes of height
Full Information
NCT ID
NCT02303873
First Posted
November 19, 2014
Last Updated
December 9, 2014
Sponsor
Peking Union Medical College Hospital
Collaborators
National Natural Science Foundation of China
1. Study Identification
Unique Protocol Identification Number
NCT02303873
Brief Title
Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta
Official Title
Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
National Natural Science Foundation of China
4. Oversight
5. Study Description
Brief Summary
Alendronate should be considered as an alternative therapy of osteogenesis imperfecta (OI) because it significantly increased areal bone mineral density (BMD) and its Z score, decreased fracture incidence, inhibited bone resorption biomarkers. Alendronate exerted beneficial roles in different age brackets, especially in young patients with OI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
an open label, prospective, self-controlled study
Arm Type
Experimental
Arm Description
Children or adolescents under the age of 18 years old with minor trauma fracture were recruited from 30 provinces of China. The diagnosis of OI was made by endocrinology department of Peking Union Medical College Hospital(PUMCH).
Intervention Type
Drug
Intervention Name(s)
Alendronate
Intervention Description
Alendronate was administrated as 70 mg/week orally (Fosamax, Merck Sharp & Dohme．LTD.).
Primary Outcome Measure Information:
Title
changes from baseline of areal BMD at lumbar spine and total hip
Time Frame
baseline and 12,24,36 months
Title
annual clinical fracture incidence
Time Frame
baseline and 12,24,36 months
Secondary Outcome Measure Information:
Title
changes of bone turnover biomarkers
Time Frame
baseline and 6,12,24,36 months
Title
changes of height
Time Frame
baseline and 12,24,36 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children or adolescents aged 0-18 years,
had either a history of at least once minor-impact fracture or age and sex adjusted areal BMD Z score of -1.0 or less at lumbar spine or total hip;
with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta;
with or without slim long bone; with or without cranial epactal bones, signs of multiple fractures, bony deformity in skeletal X-ray films.
Exclusion Criteria:
previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism;
therapy history of BPs within recent two years; severe renal failure (creatinine clearance <40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract;
unable to keep upright for at least 30 minutes daily .
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta
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