Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os Weekly
BOCOMEDEN
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedStudy Start
First participant enrolled
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2015
CompletedSeptember 5, 2025
August 1, 2025
3 years
July 20, 2012
August 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alveolar socket filled by new bone
Rate in % of the alveolar socket filled by new bone
3 months after extraction
Secondary Outcomes (1)
Mucosal injury
7 days after extraction
Study Arms (2)
Women treated by bisphosphonate
ACTIVE COMPARATORPostmenopausal osteoporotic women treated by alendronate 70 mg weekly per os
Women didn't treat by bisphosphonate
SHAM COMPARATORPostmenopausal osteoporotic women untreated by bisphosphonates
Interventions
3 dental radiographies realised immediately, then 30 days, then 90 days after dental extraction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hotel-Dieu Hospital
Nantes, 44042, France
Related Publications (1)
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.
PMID: 32404281BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian ROUX, MD, PhD
Hôpital Cochin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2012
First Posted
July 24, 2012
Study Start
September 19, 2012
Primary Completion
September 23, 2015
Study Completion
November 5, 2015
Last Updated
September 5, 2025
Record last verified: 2025-08