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

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ClinicalTrials.gov Identifier: NCT03301285
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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. 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.

Condition or disease Intervention/treatment
Multiple Disability Osteoporosis Drug: Zoledronic Acid

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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




Primary Outcome Measures :
  1. Change from baseline (before start of zoledronic acid treatment) lumbar bone density [ Time Frame: through study completion, 4 years ]
    reported in Z-score


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301285


Locations
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France
Children's Hospital - CHRU de Nancy
Vandoeuvre les nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03301285    
Other Study ID Numbers: PSS2016/ZOMETA-FEILLET/VS
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs