Multiple DisabilityZOMETANCT03301285
Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities
An observational study of Multiple Disability and Osteoporosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Multiple Disability, Osteoporosis
- What is being tested?
- Zoledronic Acid
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta)
- Absence of multiple disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Description of child population with osteoporosis in the context of motor impairment in Lorraine region
- Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities
- Description of current osteoporosis preventive care
- Description of risk factors associated to bone status (drugs)
- Evaluation of zoledronic acid treatment on fracture numbers
- Evaluation of zoledronic acid on phosphocalcic profile
- Description of side effects of zoledronic acid in this indication
- Description of treatment effects in the sub-population of children with Rett syndrome.
- Conditions
- Multiple Disability, Osteoporosis
- Being tested
- Zoledronic Acid
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Treatment of osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| Children with osteoporosis associated to multiple disabilities | Treated with zoledronic acid Receives: Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (before start of zoledronic acid treatment) lumbar bone density
reported in Z-score
Measured: through study completion, 4 years
Secondary outcomes (11)
Age
Measured: Baseline
Sex
Measured: Baseline
Height
Measured: Baseline
Weight
Measured: Baseline
Occurrence of bone fractures
Measured: Until baseline
Long-term administration of vitamin/calcium supplement or not
Measured: baseline
Administration of drugs or not
Measured: baseline
Number of fractures after the start of zoledronic acid treatment
Measured: through study completion, 4 years
Change from baseline phosphocalcic profile evaluation
Measured: through study completion, 4 years
Frequency of side effects
Measured: 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
Measured: 1 year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Jan 2017
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple DisabilityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301285
- Sponsor's protocol ID
- PSS2016/ZOMETA-FEILLET/VS
- Acronym
- ZOMETA
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities
- ClinicalTrials.gov ID
- NCT03301285
- Acronym / sponsor ID
- ZOMETA / PSS2016/ZOMETA-FEILLET/VS
- Conditions
- Multiple Disability, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Description of child population with osteoporosis in the context of motor impairment in Lorraine region
- Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities
- Description of current osteoporosis preventive care
- Description of risk factors associated to bone status (drugs)
- Evaluation of zoledronic acid treatment on fracture numbers
- Evaluation of zoledronic acid on phosphocalcic profile
- Description of side effects of zoledronic acid in this indication
- Description of treatment effects in the sub-population of children with Rett syndrome.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with osteoporosis associated to multiple disabilities | – | Drug: Zoledronic AcidTreated with zoledronic acid |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta)
- Absence of multiple disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic AcidTreatment of osteoporosis | Drug | Children with osteoporosis associated to multiple disabilities |
Primary outcome
Change from baseline (before start of zoledronic acid treatment) lumbar bone density
Time frame: through study completion, 4 years
reported in Z-score
11 secondary outcomes
Age
Time frame: Baseline
Sex
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Occurrence of bone fractures
Time frame: Until baseline
Long-term administration of vitamin/calcium supplement or not
Time frame: baseline
Administration of drugs or not
Time frame: baseline
Number of fractures after the start of zoledronic acid treatment
Time frame: through study completion, 4 years
Change from baseline phosphocalcic profile evaluation
Time frame: through study completion, 4 years
Frequency of side effects
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Disability and Osteoporosis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline (before start of zoledronic acid treatment) lumbar bone density (time frame: through study completion, 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.