Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

Completed

• Conditions: Osteoporosis; Multiple Disability
• Interventions: Drug: Zoledronic Acid

• Registration Number: NCT03301285
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities.

Secondary purposes are:

1. Description of child population with osteoporosis in the context of motor impairment in Lorraine region

2. Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities

3. Description of current osteoporosis preventive care

4. Description of risk factors associated to bone status (drugs)

5. Evaluation of zoledronic acid treatment on fracture numbers

6. Evaluation of zoledronic acid on phosphocalcic profile

7. Description of side effects of zoledronic acid in this indication

8. Description of treatment effects in the sub-population of children with Rett syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2017-09
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-28
• Last Update Submitted: 2017-09-28
• Study First Posted: 2017-10-04
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Non refusal of parents of participation of their child to the study
• Patients followed for multiple disabilities
• Osteoporosis: lumbar osteodensitometry z-score <-2.5 SD associated or not to pathologic fracture

Exclusion Criteria

• Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta)
• Absence of multiple disabilities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with osteoporosis associated to multiple disabilities	Zoledronic Acid	Treated with zoledronic acid

Primary Outcome Measures

Name	Time	Method
Change from baseline (before start of zoledronic acid treatment) lumbar bone density	through study completion, 4 years	reported in Z-score

Secondary Outcome Measures

Name	Time	Method
Weight	Baseline
Administration of drugs or not	baseline
Number of fractures after the start of zoledronic acid treatment	through study completion, 4 years
Sex	Baseline
Age	Baseline
Height	Baseline
Frequency of side effects	through study completion, 4 years
Change from baseline lumbar bone density in sub-population of children with Rett syndrome after 1 year of zoledronic acid treatment	1 year from baseline
Occurrence of bone fractures	Until baseline
Long-term administration of vitamin/calcium supplement or not	baseline
Change from baseline phosphocalcic profile evaluation	through study completion, 4 years

Trial Locations

Locations (1)

Children's Hospital - CHRU de Nancy; 🇫🇷 Vandoeuvre les nancy, France