Dental Care and Initiation of Anti-osteoporotic Therapy

Completed

• Conditions: Dental Condition; Osteoporosis
• Interventions: Procedure: Dental care; Drug: biphosphonates

• Registration Number: NCT05719818
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Primary Completion: 2022-01-04
• Study Completion: 2022-01-04
• Status Verified: 2022-11
• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• osteoporotic fracture requiring treatment with bisphosphonate or denosumab

Exclusion Criteria

• osteoporotic fracture requiring teriparatide treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical dental care	Dental care	patients requiring surgical dental care before treatment initaition.
Treatment initiation	biphosphonates	patients with a satisfactory oral assessment authorizing the immediate prescription of treatment.

Primary Outcome Measures

Name	Time	Method
Number of patients requiring surgical dental care	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

Secondary Outcome Measures

Name	Time	Method
Impact of dental care on osteoporosis treatment	Change from baseline	Dental complications apperance

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 NICE Cedex 1, Chun, France