Effects of strontium ranelate on bone quality before dental implantation.
- Conditions
- Dental implantation in osteoporotic patients or in patients at risk of osteoporotic fracture.MedDRA version: 14.1Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA 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-IT
- 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: 0
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method