Alveolar Bone Healing After Dental ExtractionBOCOMEDENNCT01648686
Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os Weekly
A study testing Dental extraction in people with Alveolar Bone Healing After Dental Extraction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Alveolar Bone Healing After Dental Extraction
- What is being tested?
- Dental extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2012to 5 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Dental extraction
- Keywords
- Alendronate, Dental extraction, Bone healing, postmenopausal women, dental radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental extractionProcedure or surgery
3 dental radiographies realised immediately, then 30 days, then 90 days after dental extraction
| Study group | Role | What they receive |
|---|---|---|
| Women treated by bisphosphonate | Active comparator | Postmenopausal osteoporotic women treated by alendronate 70 mg weekly per os Receives: Procedure: Dental extraction |
| Women didn't treat by bisphosphonate | Sham comparator | Postmenopausal osteoporotic women untreated by bisphosphonates Receives: Procedure: Dental extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar socket filled by new bone
Rate in % of the alveolar socket filled by new bone
Measured: 3 months after extraction
Secondary outcomes (1)
Mucosal injury
Direct measure of mucosal injury wtih a mini-electronic caliper
Measured: 7 days after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study start19 Sep 2012
- Primary completion23 Sep 2015
- Study completion5 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone Healing After Dental ExtractionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christian ROUX, MD, PhD, Study chair, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648686
- Sponsor's protocol ID
- P110126
- Acronym
- BOCOMEDEN
- Status last verified
- Aug 2025
- First submitted
- 20 Jul 2012
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lesclous P, Cloitre A, Catros S, Devoize L, Louvet B, Chatel C, Foissac F, Roux C. Alendronate or Zoledronic acid do not impair wound healing after tooth extraction in postmenopausal women with osteoporosis. Bone. 2020 Aug;137:115412. doi: 10.1016/j.bone.2020.115412. Epub 2020 May 20.
PubMed 32404281
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os (70 mg Weekly)
- ClinicalTrials.gov ID
- NCT01648686
- Acronym / sponsor ID
- BOCOMEDEN / P110126
- Keywords
- Alendronate, Dental extraction, Bone healing, postmenopausal women, dental radiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Sep 2012 (actual)
- Primary completion
- 23 Sep 2015 (actual)
- Study completion
- 5 Nov 2015 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women treated by bisphosphonate | Active comparator | Procedure: Dental extractionPostmenopausal osteoporotic women treated by alendronate 70 mg weekly per os |
| Women didn't treat by bisphosphonate | Sham comparator | Procedure: Dental extractionPostmenopausal osteoporotic women untreated by bisphosphonates |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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®)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental extraction3 dental radiographies realised immediately, then 30 days, then 90 days after dental extraction | Procedure or surgery | Women didn't treat by bisphosphonate, Women treated by bisphosphonate |
Primary outcome
Alveolar socket filled by new bone
Time frame: 3 months after extraction
Rate in % of the alveolar socket filled by new bone
1 secondary outcome
Mucosal injury
Time frame: 7 days after extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 32404281Lesclous P, Cloitre A, Catros S, Devoize L, Louvet B, Chatel C, Foissac F, Roux C. Alendronate or Zoledronic acid do not impair wound healing after tooth extraction in postmenopausal women with osteoporosis. Bone. 2020 Aug;137:115412. doi: 10.1016/j.bone.2020.115412. Epub 2020 May 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian ROUX, MD, PhD study chair
Hôpital Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental extraction in people with Alveolar Bone Healing After Dental Extraction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar socket filled by new bone (time frame: 3 months after extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01648686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.