Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

Osteoporosis Clinical Trial

— ZOMETA  

Official title:

Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301285
• Other study ID #: PSS2016/ZOMETA-FEILLET/VS
• Status: Completed
• Phase: N/A
• First received: September 21, 2017
• Last updated: September 28, 2017
• Start date: January 1, 2017
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Disability
• Osteoporosis

Intervention

Drug:
• Zoledronic Acid
Treatment of osteoporosis

Locations

Country	Name	City	State
France	Children's Hospital - CHRU de Nancy	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (before start of zoledronic acid treatment) lumbar bone density	reported in Z-score	through study completion, 4 years
Secondary	Age		Baseline
Secondary	Sex		Baseline
Secondary	Height		Baseline
Secondary	Weight		Baseline
Secondary	Occurrence of bone fractures		Until baseline
Secondary	Long-term administration of vitamin/calcium supplement or not		baseline
Secondary	Administration of drugs or not		baseline
Secondary	Number of fractures after the start of zoledronic acid treatment		through study completion, 4 years
Secondary	Change from baseline phosphocalcic profile evaluation		through study completion, 4 years
Secondary	Frequency of side effects		through study completion, 4 years
Secondary	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