Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os Weekly
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alveolar Bone Healing After Dental Extraction
Intervention: Dental extraction (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Christian ROUX, MD, PhD, Study Chair, Affiliation: Cochin Hospital, Paris
Overall contact:
Philippe LESCLOUS, MD, PhD, Phone: +33 2 40 41 29 40, Email: philippe.lesclous@univ-nantes.fr
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.
Clinical Details
Official title: Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os (70 mg Weekly)
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Primary outcome: Alveolar socket filled by new bone
Secondary outcome: Mucosal injury
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
Minimum age: 45 Years.
Maximum age: 70 Years.
Gender(s): Female.
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
Locations and Contacts
Philippe LESCLOUS, MD, PhD, Phone: +33 2 40 41 29 40, Email: philippe.lesclous@univ-nantes.fr
Hotel-Dieu Hospital, Nantes 44042, France; Recruiting
Philippe LESCLOUS, MD, PhD, Phone: +33 2 40 41 29 40, Email: philippe.lesclous@univ-nantes.fr
Philippe LESCLOUS, MD, PhD, Principal Investigator
Additional Information
Starting date: September 2012
Last updated: April 20, 2015
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