Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os Weekly
Condition: Alveolar Bone Healing After Dental Extraction
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the oral alendronate treatment of
      post-menopausal osteoporosis could be a risk factor for jaw bone healing after dental
      extraction.
    

Detailed description: 
      Alendronate is the main oral bisphosphonate used in the treatment and the prevention of the
      postmenopausal osteoporosis because of its high antiresorbant ability for bone tissue.
      Alendronate delayed bone healing after dental extraction on animals models, murine as canine.
      Anti-angiogenic and anti-osteoclastic characteristics are suggested to explain this
      phenomenon. There is no available data in human and it is now well known that bisphosphonates
      are involved in the occurrence of osteonecrosis of the jaws even if this major adverse effect
      seems to be very seldom with oral alendronate. Moreover, bisphosphonate showed toxicity for
      oral mucosal cells. The main aim of this study is to quantify the impact of oral alendronate
      weekly treatment on bone and mucosa healing after dental extraction in postmenopausal
      osteoporotic women. A secondary aim is to investigate a panel of 50 peptids potentially
      involved in bone and mucosal healing and to detect changes in their rates by salivary
      proteomic approach. The investigators hope so identify salivary biomarkers of bone and/or
      mucosa healing in these women.

      Our hypothesis is that after dental extraction, bone healing could be delayed in
      postmenopausal osteoporotic women treated with oral weekly alendronate (BP+ group) versus
      matched osteoporotic women untreated with bisphosphonates (BP- group).

      This is a prospective and multicentric (17 investigation centers dispatched in France) study
      including 140 osteoporotic postmenopausal women treated weekly with oral bisphosphonates (BP+
      group) and 140 osteoporotic postmenopausal women untreated with bisphosphonates (BP- group).
      This is a clinical follow-up study (T0, T0 + 7, T0 + 30, T0 + 90 days), a radiological study
      (T0, T0 + 30, T0 + 90 days), and a salivary proteomic study (T0, T0 + 30, T0 + 90 days). This
      is a 4 years study starting in april 2012 (anticipated date).

      The main investigated parameters are:

        -  Bone healing: Bone filling rate (in %) of the post-extractional alveolar socket (BFR) at
           T0, T0 + 30 and T0 + 90 days by a radiographic approach.

        -  Mucosa healing: mucosal injury by metric approach at T0 and T0 + 30 days.

        -  Salivary biomarkers: Fifty peptides by proteomic approach at T0 and T0 + 30 days;

      The investigators expect that this study will allow us to build a reference scale of bone and
      mucosa healing in osteoporotic postmenopausal women treated weekly by oral alendronate. This
      scale will be a helpful tool for dental physicians. The investigators hope also to identify
      salivary biomarkers variations to make a diagnosis and a prognosis tool of worse bone healing
      in these patients.

      Perspectives of this study is to constitute a national network of deleterious effect on bone
      healing in such women patients and to up-date guidelines in this area.
    

Intervention name(s): Dental extraction
Intervention type(s): Procedure
Intervention description(s): 3 dental radiographies realised immediately, then 30 days, then 90 days after dental extraction
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Alendronate; Dental extraction; Bone healing; postmenopausal women; dental radiography