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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648686
First received: July 20, 2012
Last updated: August 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Alveolar Bone Healing After Dental Extraction
Procedure: Dental extraction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os (70 mg Weekly)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Alveolar socket filled by new bone [ Time Frame: 3 months after extraction ] [ Designated as safety issue: No ]
    Rate in % of the alveolar socket filled by new bone


Secondary Outcome Measures:
  • Mucosal injury [ Time Frame: 7 days after extraction ] [ Designated as safety issue: No ]
    Direct measure of mucosal injury wtih a mini-electronic caliper


Estimated Enrollment: 280
Study Start Date: September 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648686

Contacts
Contact: Philippe LESCLOUS, MD, PhD +33 2 40 41 29 40 philippe.lesclous@univ-nantes.fr
Contact: Laurence LECOMTE, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Hotel-Dieu Hospital Recruiting
Nantes, France, 44042
Contact: Philippe LESCLOUS, MD, PhD    +33 2 40 41 29 40    philippe.lesclous@univ-nantes.fr   
Principal Investigator: Philippe LESCLOUS, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Christian ROUX, MD, PhD Cochin Hospital, Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648686     History of Changes
Other Study ID Numbers: P110126
Study First Received: July 20, 2012
Last Updated: August 2, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alendronate
Dental extraction
Bone healing
postmenopausal women
dental radiography

Additional relevant MeSH terms:
Alendronate
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014