Bisphosphonates Effects On Alveolar Bone Among Osteoporotic Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      Osteoporosis is a public health problem. It is a skeletal disease being treated by
      Bisphosphonates as the first choice medication. The effects of these drugs were investigated
      for periodontal disease treatment both locally and systemically. However, it is very
      important to know their indirect effects on alveolar bone (i.e. their effects when used for
      treating osteoporosis). So, in this study, alternations that involve the alveolar bone when
      osteoporotic women use bisphosphonates will be studied radiologically using cone-beam CT and
      digital panoramic radiography. The goal is to provide dentists with information about changes
      in the characterization of the alveolar bone among these women. This is important for both
      periodontology and implantology. Maxillary and mandibular bone structural characterization
      among osteoporotic women had not been studied before. Furthermore, in an opposite direction,
      dental radiographs may aid in detecting osteoporosis.

      Osteoporotic women, under bisphosphonates therapy or not, will be invited to participate in
      this study. In addition, osteopenic and normal women regarding bone fragility will be
      included too, for comparison purposes. Panoramic radiographs will be taken. In addition,
      women under bisphosphonates for 6 months or more will be scanned by Cone -beam CT as it can
      give an idea about bone histomorphometry with a low radiation dose.
    

Detailed description: 
      Osteoporosis is a skeletal disease characterized by a low bone mass, deterioration of the
      bone structure and an increased risk of bone fracture. Although jaws are not at risk of
      fracture, they revealed changes due to the disease. Bisphosphonates are the most common
      medical therapy for osteoporosis as they improve bone structure and reduce its absorption.
      From a periodontal point of view, it was suggested as an adjunctive therapy for periodontal
      bone loss. Controversy exists regarding their effects, however. In addition, their effects on
      the periodontal status and jaw bones are unknown when these drugs are prescribed for treating
      osteoporosis, i.e. not for periodontal purposes. It is also unknown whether their effects on
      alveolar bone, if any, can be detected by simple radiographs (such as panoramic radiographs)
      or required advanced techniques (e.g. Cone-beam CT).

      In this study, their effects on alveolar bone are going to be evaluated using panoramic
      radiography and Cone-beam CT, as well as the clinical parameters of periodontal diseases.
      Cone-beam CT will also offer a way to compare bone histomorphometry of the jaws between
      groups. Bisphosphonates will be prescribed by physicians of osteoporotic women. The
      investigators will not interfere drug administration at all. Thus, the investigators can test
      their indirect effect on jaw bones. Osteoporotic women, who used bisphosphonates for 6 months
      minimum, will be invited to participate in this investigation. In addition, women with
      osteoporosis who are not under one of the bisphosphonates will be invited too, as a control.
      Control group will also include a number of osteopenic and normal women for comparison
      purposes, as these medications are not indicated for them. Women should be free of bone
      diseases other than osteoporosis or osteopenia.

      On panoramic radiographs, radiographic bone density and mandibular cortical index will be
      assessed. Aluminum step-wedge will be used with panoramic radiography as it offers more
      accurate density measurements. In Cone-beam CT, radiographic density, apparent bone
      histomorphometric analysis and radiographic parameters of the periodontal disease will be
      assessed. Clinical measurements of periodontal disease will be recorded for two purposes.
      First, to adjust for the confounding factor (periodontal disease) when evaluating the
      trabecular bone between groups. Second, to test if using these drugs improve the periodontal
      status as their benefits are still controversial.
    

Intervention name(s): Bisphosphonates
Intervention type(s): Drug
Intervention MeSH terms: Diphosphonates
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who were referred to perform Dual Energy X-Ray Absorptiometry (DXA) examination will
        be invited to participate in this study if they were diagnosed with osteoporosis. They may
        be under bisphosphonates or not. They will be met in Alassd and Almowsat
        University-Hospitals where DXA is available. If they meet inclusion criteria, mentioned
        below, they will be invited.
      
Keywords: Alveolar bone; Bisphosphonates; Cone-beam CT; Osteoporosis