Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
45 participants
INTERVENTIONAL
2004-01-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant
alendronate once weekly 70mg
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
2
placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant
placebo
placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant
3
dental implant, calcium 1000mg and Vitamin D 800 IU daily
No interventions assigned to this group
Interventions
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alendronate once weekly 70mg
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
placebo
placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
75 Years
FEMALE
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Center for Muscle and Bone Research
Principal Investigators
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Dieter Felsenberg, Prof. D.r
Role: STUDY_CHAIR
Leader of the center for muscle and bone research, Charité
Locations
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Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Dieter Felsenberg, Prof. Dr.
Role: primary
Hendrikje Boerst, Dipl. Wiss. org.
Role: backup
Other Identifiers
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OPOZAHN
Identifier Type: -
Identifier Source: org_study_id