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OpenTrials
Completed

NCT Number: NCT05719818

Dental Care and Initiation of Anti-osteoporotic Therapy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NICE

Nice, CHUN, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • osteoporotic fracture requiring treatment with bisphosphonate or denosumab

Exclusion criteria

  • osteoporotic fracture requiring teriparatide treatment

Treatment and study plan

biphosphonates

Drug

Initiation of bisphosphonate therapy

Dental care

Procedure

Surgical dental care

Primary outcomes

  1. 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

Secondary outcomes

  1. Impact of dental care on osteoporosis treatment

    Time frame: Change from baseline

    Delay of treatment implementation (in days)

  2. Impact of dental care on osteoporosis treatment

    Time frame: Change from baseline

    New osteoportic fracture occurence (in day since treatment start)

  3. Impact of dental care on osteoporosis treatment

    Time frame: Change from baseline

    Dental complications apperance

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2023
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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