Back to resultsOsteoporosis and Dental Implant (OPOZAHN)
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
alendronate once weekly 70mg
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis,, bisphosphonate, therapy, dental implant
Eligibility Criteria
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
Sites / Locations
- Centre for Muscle and Bone Research, Charité - Campus Benjamin FranklinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
1
2
3
Arm Description
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant
placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant
dental implant, calcium 1000mg and Vitamin D 800 IU daily
Outcomes
Primary Outcome Measures
Dental CT
Secondary Outcome Measures
Full Information
NCT ID
NCT00727493
First Posted
July 31, 2008
Last Updated
August 1, 2008
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00727493
Brief Title
Osteoporosis and Dental Implant
Acronym
OPOZAHN
Official Title
Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis,, bisphosphonate, therapy, dental implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant
Arm Title
3
Arm Type
No Intervention
Arm Description
dental implant, calcium 1000mg and Vitamin D 800 IU daily
Intervention Type
Drug
Intervention Name(s)
alendronate once weekly 70mg
Intervention Description
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant
Primary Outcome Measure Information:
Title
Dental CT
Time Frame
baseline, and 3,6,12 months after baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dieter Felsenberg, Prof. Dr.
Phone
+490384453046
Email
dieter.felsenberg@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hendrikje Boerst, Dipl. Wiss org.
Phone
+490384454745
Email
hendrikje.boerst@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Felsenberg, Prof. D.r
Organizational Affiliation
Leader of the center for muscle and bone research, Charité
Official's Role
Study Chair
Facility Information:
Facility Name
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dieter Felsenberg, Prof. Dr.
Phone
+493084453046
First Name & Middle Initial & Last Name & Degree
Hendrikje Boerst, Dipl. Wiss. org.
Phone
+493084454745
Email
hendrikje.boerst@charite.de
First Name & Middle Initial & Last Name & Degree
Dieter Felsenberg, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Anton ° Friedman, Dr.
12. IPD Sharing Statement
Learn more about this trial
Osteoporosis and Dental Implant
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