Effects of strontium ranelate on bone quality before dental implantatio
- Conditions
- Dental implantation in osteoporotic patients or in patients at risk of osteoporotic fractureMedDRA version: 14.1Level: PTClassification code 10064143Term: Dental implantationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2011-002370-23-DE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
- Men or post-menopausal women
- > or = 50 years
- Osteoporotic patient or with a risk of osteoporotic fracture
- Eligible for a premolar extraction followed by a dental implant placement
- Without inter-radicular septum at extraction
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
- Pathological findings in the jaw bone
- History of maxillar or cervico-facial irradiation
- Chronic inflammatory rheumatoid disease
- Inflammatory or metabolic bone disease, excluding osteoporosis
- Hypersensitivity to the active substances or to any of the excipients or to tetracycline
- Current or previous venous thromboembolism events, including deep vein thrombosis and pulmonary embolism, or patients at high risk of venous thromboembolism.
- Temporary or permanent immobilization due to e.g. post-surgical recovery or prolonged bed rest.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effects of 4-month-treatment with strontium ranelate in comparison with placebo on alveolar bone quality and alveolar bone turnover on alevolar biopsies;Secondary Objective: - To assess the effect of 4 month-treatment with strontium ranelate on :<br> - alveolar bone microarchitecture<br> - alveolar bone texture<br>- To assess biological and clinical safety over 6 months<br><br>- Implant stability will be assessed after 6 months of treatment;Primary end point(s): - Evaluation of the efficacy by assessing alveolar bone quality and alveolar bone turnover;Timepoint(s) of evaluation of this end point: - Alveolar bone quality will be assessed by nanoindentation at M004<br>- Alveolar bone turnover will be assessed by histomorphometry at M004
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Other parameters will be assessed by histomorphometry : resorption, microarchitecture,bone microarchitecture, texture analysis and implant stability<br>- Safety will be assessed by: - collection of adverse events<br> - biological parameters evaluation<br> - clinical examination;Timepoint(s) of evaluation of this end point: - Resorption, microarchitecture and bone microarchitecture will be assessed at M004<br>- Texture analysis will be assessed at M000 and M004<br>- Implant stability will be assessed at M006<br>- Safety measurements over 6 months.