Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities (ZOMETA)

Central Hospital, Nancy, France

Status: Completed

Conditions: Osteoporosis; Multiple Disability

Treatments: Drug: Zoledronic Acid

Study type: Observational

Funder types: Other

Identifiers

NCT03301285

PSS2016/ZOMETA-FEILLET/VS

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Children with osteoporosis associated to multiple disabilities

Description:

Treated with zoledronic acid

Treatment:

Drug: Zoledronic Acid