Dental Care and Initiation of Anti-osteoporotic Therapy

Osteoporosis Clinical Trial

Official title:

Dental Care and Initiation of Anti-osteoporotic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719818
• Other study ID #: 22Rhumato04
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: January 4, 2022

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: January 4, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• osteoporotic fracture requiring treatment with bisphosphonate or denosumab

Exclusion Criteria:

• osteoporotic fracture requiring teriparatide treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• biphosphonates
Initiation of bisphosphonate therapy

Procedure:
• Dental care
Surgical dental care

Locations

Country	Name	City	State
France	CHU de NICE	NICE Cedex 1	Chun

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 months
Secondary	Impact of dental care on osteoporosis treatment	Delay of treatment implementation (in days)	Change from baseline
Secondary	Impact of dental care on osteoporosis treatment	New osteoportic fracture occurence (in day since treatment start)	Change from baseline
Secondary	Impact of dental care on osteoporosis treatment	Dental complications apperance	Change from baseline