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CompletedNCT03301285ZOMETAUpdated Oct 4, 2017

Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

An observational study in Multiple Disability and Osteoporosis, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-10-04.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Retrospective
Enrollment
60
Ages
Up to 18 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Multiple Disability
  • Osteoporosis

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03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta)
  • Absence of multiple disabilities
04

Study design

Observational model
Case-crossover
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Children with osteoporosis associated to multiple disabilities

    Treated with zoledronic acid

    Drug: Zoledronic Acid

Interventions

  • DrugZoledronic Acid

    Treatment of osteoporosis

05

What researchers measure

Primary outcomes

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

    reported in Z-score

    Time frame: through study completion, 4 years

Secondary outcomes

  1. Age

    Time frame: Baseline

  2. Sex

    Time frame: Baseline

  3. Height

    Time frame: Baseline

  4. Weight

    Time frame: Baseline

  5. Occurrence of bone fractures

    Time frame: Until baseline

  6. Long-term administration of vitamin/calcium supplement or not

    Time frame: baseline

  7. Administration of drugs or not

    Time frame: baseline

  8. Number of fractures after the start of zoledronic acid treatment

    Time frame: through study completion, 4 years

  9. Change from baseline phosphocalcic profile evaluation

    Time frame: through study completion, 4 years

  10. Frequency of side effects

    Time frame: through study completion, 4 years

  11. 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

06

Study locations

1 site
  • Children's Hospital - CHRU de Nancy
    Vandoeuvre les nancy, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03301285
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Oct 4, 2017
Start date
Jan 1, 2017
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Oct 4, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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