Dental Care and Initiation of Anti-osteoporotic Therapy

NCT05719818 | Completed

• 1 other identifier: 22Rhumato04
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Condition; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Impact of dental care on osteoporosis treatment

  Change from baseline

• Impact of dental care on osteoporosis treatment

  Change from baseline

• Impact of dental care on osteoporosis treatment

  Change from baseline

Study Arms (2)

Treatment initiation

patients with a satisfactory oral assessment authorizing the immediate prescription of treatment.

Drug: biphosphonates

Surgical dental care

patients requiring surgical dental care before treatment initaition.

Procedure: Dental care

Interventions

biphosphonates DRUG

Initiation of bisphosphonate therapy

Treatment initiation

Dental care PROCEDURE

Surgical dental care

Surgical dental care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• osteoporotic fracture requiring treatment with bisphosphonate or denosumab

You may not qualify if:

• osteoporotic fracture requiring teriparatide treatment

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, CHUN, 06000, France

Location

MeSH Terms

Conditions

Tooth Diseases; Osteoporosis

Interventions

Diphosphonates; Dental Care

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: February 9, 2023
• Study Start: January 3, 2019
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: February 9, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)