Clinical trial NCT01648686: Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os Weekly
Official title: Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os (70 mg Weekly)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Healing After Dental Extraction
Keywords: Alendronate
Dental extraction
Bone healing
postmenopausal women
dental radiography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 66
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal osteoporotic women
* Treated with alendronate per os (70 pg weekly) for BP+ experimental group and untreated with this therapy for the BP
* Control group
* Subjected to single root tooth extraction- 45 to 70 years of age

Exclusion Criteria:

* Maxillofacial irradiations
* Dental extraction with adjunction of material interfering with bone healing
* Severe pathologies inconsistent with this study
* Bisphosphonate treatment for BP- control group
* Women treated with denosumab (prolia®)
* Women already included to an another dental extraction

Primary outcomes:
measure: Alveolar socket filled by new bone
timeFrame: 3 months after extraction
Secondary outcomes:
measure: Mucosal injury
timeFrame: 7 days after extraction
Other outcomes:
Locations:
city: Nantes
country: France
facility: Hotel-Dieu Hospital
Study officials:
affiliation: Hôpital Cochin
name: Christian ROUX, MD, PhD
role: STUDY_CHAIR
References: