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Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02303873
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : December 10, 2014
National Natural Science Foundation of China
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Osteogenesis Imperfecta Drug: Alendronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study
Study Start Date : March 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: an open label, prospective, self-controlled study
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).
Drug: Alendronate
Alendronate was administrated as 70 mg/week orally (Fosamax, Merck Sharp & Dohme.LTD.).

Primary Outcome Measures :
  1. changes from baseline of areal BMD at lumbar spine and total hip [ Time Frame: baseline and 12,24,36 months ]
  2. annual clinical fracture incidence [ Time Frame: baseline and 12,24,36 months ]

Secondary Outcome Measures :
  1. changes of bone turnover biomarkers [ Time Frame: baseline and 6,12,24,36 months ]
  2. changes of height [ Time Frame: baseline and 12,24,36 months ]

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. children or adolescents aged 0-18 years,
  2. 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;
  3. with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta;
  4. 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:

  1. previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism;
  2. therapy history of BPs within recent two years; severe renal failure (creatinine clearance <40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract;
  3. unable to keep upright for at least 30 minutes daily .
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Responsible Party: Peking Union Medical College Hospital Identifier: NCT02303873    
Other Study ID Numbers: No. 2007-03-12
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Osteogenesis Imperfecta
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs