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Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

NCT ID: NCT03301285

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Multiple Disability Osteoporosis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children with osteoporosis associated to multiple disabilities

Treated with zoledronic acid

Zoledronic Acid

Intervention Type DRUG

Treatment of osteoporosis

Interventions

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Zoledronic Acid

Treatment of osteoporosis

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital - CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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PSS2016/ZOMETA-FEILLET/VS

Identifier Type: -

Identifier Source: org_study_id