Dental ConditionNCT05719818
Dental Care and Initiation of Anti-osteoporotic Therapy
An observational study of Dental Condition and Osteoporosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The initiation of bisphosphonate therapy for osteoporosis requires an assessment of the oral status to prevent the risk of osteonecrosis of the jaw. This recommendation is sometimes a hindrance to the initiation of treatment or may be responsible for a delay in treatment or even the failure to initiate treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Condition, Osteoporosis
- What is being tested?
- biphosphonates and Dental care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 338 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2019to 4 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in the rhumatologic department - Nice University hospital for osteoporotic fracture and for who the treatment, either bisphosphonate or denosumab, has justified a dental evaluation
Who may be able to join
- osteoporotic fracture requiring treatment with bisphosphonate or denosumab
Who cannot join
- osteoporotic fracture requiring teriparatide treatment
Trial locations and contacts
1 site in 1 country.
About this study
The initiation of bisphosphonate therapy for osteoporosis requires an assessment of the oral status to prevent the risk of osteonecrosis of the jaw. This recommendation is sometimes a hindrance to the initiation of treatment or may be responsible for a delay in treatment or even the failure to initiate treatment. However, in the case of a severe osteoporotic fracture (femoral or humeral neck fracture, vertebral fracture or pelvic fracture), treatment must be rapid because of the major risk of refracture in the short term (multiplied by 5 in the 2 years following the fracture).
In the rheumatology department of the Nice University Hospital, the investigator team take care of patients with osteoporotic fractures either directly in hospital or referred by the orthopedics department as part of a care program. For these patients, the team perform an etiological assessment, bone densitometry and evaluation of the oral status with dental panoramic and tele-expertise to determine if there is an indication to perform surgical care before starting the treatment.
Therefore, the investigator aimed to describe the number of patients requiring dental surgery befor the initiation of bisphosphonate or denosumab treatment before to introduce treatment for osteoporosis
- Conditions
- Dental Condition, Osteoporosis
- Being tested
- biphosphonates, Dental care
- Medical subject headings
- Tooth Diseases, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biphosphonatesDrug
Initiation of bisphosphonate therapy
Dental careProcedure or surgery
Surgical dental care
| Study group | Role | What they receive |
|---|---|---|
| Treatment initiation | patients with a satisfactory oral assessment authorizing the immediate prescription of treatment. Receives: Drug: biphosphonates | |
| Surgical dental care | patients requiring surgical dental care before treatment initaition. Receives: Procedure: Dental care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients requiring surgical dental care
describe the number of patients requiring surgical dental care before to start osteoporosis treatment vs the number of patients with a satisfactory oral assessment authorizing the immediate prescription of treatment
Measured: 15 months
Secondary outcomes (3)
Impact of dental care on osteoporosis treatment
Delay of treatment implementation (in days)
Measured: Change from baseline
Impact of dental care on osteoporosis treatment
New osteoportic fracture occurence (in day since treatment start)
Measured: Change from baseline
Impact of dental care on osteoporosis treatment
Dental complications apperance
Measured: Change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start3 Jan 2019
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ConditionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719818
- Sponsor's protocol ID
- 22Rhumato04
- Status last verified
- Nov 2022
- First submitted
- 27 Dec 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not scheduled
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Care and Initiation of Anti-osteoporotic Therapy
- ClinicalTrials.gov ID
- NCT05719818
- Acronym / sponsor ID
- 22Rhumato04
- Conditions
- Dental Condition, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 9 Feb 2023 (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 initiation of bisphosphonate therapy for osteoporosis requires an assessment of the oral status to prevent the risk of osteonecrosis of the jaw. This recommendation is sometimes a hindrance to the initiation of treatment or may be responsible for a delay in treatment or even the failure to initiate treatment. However, in the case of a severe osteoporotic fracture (femoral or humeral neck fracture, vertebral fracture or pelvic fracture), treatment must be rapid because of the major risk of refracture in the short term (multiplied by 5 in the 2 years following the fracture).
In the rheumatology department of the Nice University Hospital, the investigator team take care of patients with osteoporotic fractures either directly in hospital or referred by the orthopedics department as part of a care program. For these patients, the team perform an etiological assessment, bone densitometry and evaluation of the oral status with dental panoramic and tele-expertise to determine if there is an indication to perform surgical care before starting the treatment.
Therefore, the investigator aimed to describe the number of patients requiring dental surgery befor the initiation of bisphosphonate or denosumab treatment before to introduce treatment for osteoporosis
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment initiation | – | Drug: biphosphonatespatients with a satisfactory oral assessment authorizing the immediate prescription of treatment. |
| Surgical dental care | – | Procedure: Dental carepatients requiring surgical dental care before treatment initaition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the rhumatologic department - Nice University hospital for osteoporotic fracture and for who the treatment, either bisphosphonate or denosumab, has justified a dental evaluation
Key inclusion criteria (1 listed)
- osteoporotic fracture requiring treatment with bisphosphonate or denosumab
Key exclusion criteria (1 listed)
- osteoporotic fracture requiring teriparatide treatment
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 |
|---|---|---|
| biphosphonatesInitiation of bisphosphonate therapy | Drug | Treatment initiation |
| Dental careSurgical dental care | Procedure or surgery | Surgical dental care |
Primary outcome
Number of patients requiring surgical dental care
Time frame: 15 months
describe the number of patients requiring surgical dental care before to start osteoporosis treatment vs the number of patients with a satisfactory oral assessment authorizing the immediate prescription of treatment
3 secondary outcomes
Impact of dental care on osteoporosis treatment
Time frame: Change from baseline
Impact of dental care on osteoporosis treatment
Time frame: Change from baseline
Impact of dental care on osteoporosis treatment
Time frame: Change 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 9 Feb 2023.
- Individual participant dataSharing planned: No. Not scheduled
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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 Dental Condition and Osteoporosis, run by Centre Hospitalier Universitaire de Nice 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 1 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 Feb 2023. 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?
Number of patients requiring surgical dental care (time frame: 15 months). 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 Feb 2023.