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

September 28, 2017 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre les nancy, France
        • Children's Hospital - CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with osteoporosis associated to multiple disabilities
Treated with zoledronic acid
Drug: Zoledronic Acid
Treatment of osteoporosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline (before start of zoledronic acid treatment) lumbar bone density
Time Frame: through study completion, 4 years
reported in Z-score
through study completion, 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Height
Time Frame: Baseline
Baseline
Weight
Time Frame: Baseline
Baseline
Age
Time Frame: Baseline
Baseline
Sex
Time Frame: Baseline
Baseline
Occurrence of bone fractures
Time Frame: Until baseline
Until baseline
Long-term administration of vitamin/calcium supplement or not
Time Frame: baseline
baseline
Administration of drugs or not
Time Frame: baseline
baseline
Number of fractures after the start of zoledronic acid treatment
Time Frame: through study completion, 4 years
through study completion, 4 years
Change from baseline phosphocalcic profile evaluation
Time Frame: through study completion, 4 years
through study completion, 4 years
Frequency of side effects
Time Frame: through study completion, 4 years
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
Time Frame: 1 year from baseline
1 year from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 28, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS2016/ZOMETA-FEILLET/VS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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