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

Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02303873

Enrollment

Registered

2014-12-01

Start date

2007-03-31

Completion date

2014-08-31

Last updated

2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteogenesis Imperfecta

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.

Interventions

DRUGAlendronate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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 .

Design outcomes

Primary

Measure	Time frame
changes from baseline of areal BMD at lumbar spine and total hip	baseline and 12,24,36 months
annual clinical fracture incidence	baseline and 12,24,36 months

Secondary

Measure	Time frame
changes of bone turnover biomarkers	baseline and 6,12,24,36 months
changes of height	baseline and 12,24,36 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026