Osteoporosis
Conditions
Keywords
osteoporosis,, bisphosphonate, therapy, dental implant
Brief summary
The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.
Interventions
DRUGalendronate once weekly 70mg
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
DRUGplacebo
placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dental CT | baseline, and 3,6,12 months after baseline |
Countries
Germany
Contacts
Primary ContactDieter Felsenberg, Prof. Dr.
Backup ContactHendrikje Boerst, Dipl. Wiss org.
Outcome results
None listed