Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os Weekly (BOCOMEDEN)

August 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os (70 mg Weekly)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44042
        • Hotel-Dieu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Women treated by bisphosphonate
Postmenopausal osteoporotic women treated by alendronate 70 mg weekly per os
Procedure: Dental extraction
3 dental radiographies realised immediately, then 30 days, then 90 days after dental extraction
Sham Comparator: Women didn't treat by bisphosphonate
Postmenopausal osteoporotic women untreated by bisphosphonates
Procedure: Dental extraction
3 dental radiographies realised immediately, then 30 days, then 90 days after dental extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar socket filled by new bone
Time Frame: 3 months after extraction
Rate in % of the alveolar socket filled by new bone
3 months after extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucosal injury
Time Frame: 7 days after extraction
Direct measure of mucosal injury wtih a mini-electronic caliper
7 days after extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Unité de Recherche Clinique Necker Cochin, France

Investigators

  • Study Chair: Christian ROUX, MD, PhD, Hopital Cochin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2012

Primary Completion (Actual)

September 23, 2015

Study Completion (Actual)

November 5, 2015

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimated)

July 24, 2012

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alveolar Bone Healing After Dental Extraction

Clinical Trials on Dental extraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe