Osteoporosis | Osteoporosis and Dental Implant
Osteoporosis research study
What is the primary objective of this study?
The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.
Who is eligible to participate?
Inclusion Criteria: - Postmenopausal women > 2 years after menopause - Age between 60 and 75 years - Possibility to insert a dental implant - Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group) Exclusion Criteria: - Pathological findings in the jaw bone - Chronic inflammatory rheumatoid disease - Bisphosphonate treatments during the last 12 months - Inflammatory or metabolic bone disease, excluding osteoporosis - Systemic corticosteroid treatments of more than one month within previous 12 months - Severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:alendronate once weekly 70mgalendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
Drug:placeboplacebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant
2placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant
3dental implant, calcium 1000mg and Vitamin D 800 IU daily
Start Date: January 2004
Completed Date: April 2010
Phase: Phase 4
Primary Outcome: Dental CT
Study sponsors, principal investigator, and references
Principal Investigator: Dieter Felsenberg, Prof. D.r
Lead Sponsor: Charite University, Berlin, Germany