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

NCT ID: NCT02303873

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteogenesis Imperfecta

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Alendronate

Intervention Type DRUG

Alendronate was administrated as 70 mg/week orally (Fosamax, Merck Sharp \& Dohme．LTD.).

Interventions

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Alendronate

Alendronate was administrated as 70 mg/week orally (Fosamax, Merck Sharp \& Dohme．LTD.).

Intervention Type DRUG

Eligibility Criteria

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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 .
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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No. 2007-03-12

Identifier Type: -

Identifier Source: org_study_id