Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

NCT03301285 | Completed

• 1 other identifier: PSS2016/ZOMETA-FEILLET/VS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Description of child population with osteoporosis in the context of motor impairment in Lorraine region
2. 2.Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities
3. 3.Description of current osteoporosis preventive care
4. 4.Description of risk factors associated to bone status (drugs)
5. 5.Evaluation of zoledronic acid treatment on fracture numbers
6. 6.Evaluation of zoledronic acid on phosphocalcic profile
7. 7.Description of side effects of zoledronic acid in this indication
8. 8.Description of treatment effects in the sub-population of children with Rett syndrome.

Conditions

Multiple Disability; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline (before start of zoledronic acid treatment) lumbar bone density

  reported in Z-score

  through study completion, 4 years

Secondary Outcomes (11)

• Age

  Baseline

• Sex

  Baseline

• Height

  Baseline

• Weight

  Baseline

• Occurrence of bone fractures

  Until baseline

Study Arms (1)

Children with osteoporosis associated to multiple disabilities

Treated with zoledronic acid

Drug: Zoledronic Acid

Interventions

Zoledronic Acid DRUG

Treatment of osteoporosis

Children with osteoporosis associated to multiple disabilities

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children followed for osteoporosis associated to multiple disabilities, treated with zoledronic acid, followed at pediatric department of Nancy hospital, between 01/01/2012 and 11/01/2016.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Children's Hospital - CHRU de Nancy

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 4, 2017
• Study Start: January 1, 2017
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)