Osteoporosis and Dental Implant
OPOZAHN
Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 4, 2008
August 1, 2008
6 years
July 31, 2008
August 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dental CT
baseline, and 3,6,12 months after baseline
Study Arms (3)
1
ACTIVE COMPARATORalendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant
2
PLACEBO COMPARATORplacebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant
3
NO INTERVENTIONdental implant, calcium 1000mg and Vitamin D 800 IU daily
Interventions
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, 12200, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dieter Felsenberg, Prof. D.r
Leader of the center for muscle and bone research, Charité
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 4, 2008
Study Start
January 1, 2004
Primary Completion
January 1, 2010
Study Completion
April 1, 2010
Last Updated
August 4, 2008
Record last verified: 2008-08