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Completed

NCT Number: NCT03301285

Efficacy of Zoledronic Acid in Osteoporosis of 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.

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Key information

Conditions

Multiple Disability Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital - CHRU de Nancy

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid

Drug

Treatment of osteoporosis

Primary outcomes

  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 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ZOMETA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2017
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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