Bone FragileBisphosphonateNCT04012320
Efficacy and Safety on the Use of Bisphosphonates in Paediatrics
An observational study of Bone Fragile and Bisphosphonate-Associated Osteonecrosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bone Fragile, Bisphosphonate-Associated Osteonecrosis, Children
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2018to 31 Dec 2018
- 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 patients under 18 years old who started intravenous bisphosphonates for primary or secondary osteoporosis in paediatric departments of Montpellier and Nimes University Hospitals between January 2012 and August 2018 were included.
Who may be able to join
- be under 18 years of age
- have been treated by intravenous bisphosphonates for primary or secondary osteoporosis
Who cannot join
- be over 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.
- Being tested
- No intervention, observational study
- Medical subject headings
- Bisphosphonate-Associated Osteonecrosis of the Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational studyOther
No intervention, observational study
| Study group | Role | What they receive |
|---|---|---|
| Pamidronate therapy | Not described Receives: Other: No intervention, observational study | |
| Zoledronate therapy | Not described Receives: Other: No intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
fracture rates
(numbers)
Measured: 2 years
bone mineral density
(Z-score)
Measured: 2 years
pain frequency
(never, occasional, regular)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start31 Oct 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FragileStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012320
- Sponsor's protocol ID
- Local/2018/TAT-01
- Acronym
- Bisphosphonate
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety on the Use of Bisphosphonates in Paediatrics
- ClinicalTrials.gov ID
- NCT04012320
- Acronym / sponsor ID
- Bisphosphonate / Local/2018/TAT-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Jul 2019 (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 investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pamidronate therapy | – | Other: No intervention, observational study |
| Zoledronate therapy | – | Other: No intervention, observational study |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients under 18 years old who started intravenous bisphosphonates for primary or secondary osteoporosis in paediatric departments of Montpellier and Nimes University Hospitals between January 2012 and August 2018 were included.
Key inclusion criteria (2 listed)
- be under 18 years of age
- have been treated by intravenous bisphosphonates for primary or secondary osteoporosis
Key exclusion criteria (1 listed)
- be over 18 years of age
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 |
|---|---|---|
| No intervention, observational studyNo intervention, observational study | Other | Pamidronate therapy, Zoledronate therapy |
Primary outcome
fracture rates
Time frame: 2 years
(numbers)
bone mineral density
Time frame: 2 years
(Z-score)
pain frequency
Time frame: 2 years
(never, occasional, regular)
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 9 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Bone Fragile
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Recruiting
Physical Activity and Community EmPOWERment Project
Intellectual Disability, Neurodevelopmental Disorders
RecruitingObservational study
Orthorexia Nervosa in Postmenopausal Osteoporosis
Osteoporosis
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 Bone Fragile and Bisphosphonate-Associated Osteonecrosis, run by Centre Hospitalier Universitaire de Nīmes 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 2 inclusion and 1 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 9 Jul 2019. 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?
fracture rates (time frame: 2 years). The study lists 3 primary outcomes in all. 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 9 Jul 2019.