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Osteoporosis and Dental Implant (OPOZAHN)

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ClinicalTrials.gov Identifier: NCT00727493
Recruitment Status : Unknown
Verified August 2008 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : August 4, 2008
Last Update Posted : August 4, 2008
Sponsor:
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: alendronate once weekly 70mg Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis
Study Start Date : January 2004
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant
Drug: alendronate once weekly 70mg
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
Placebo Comparator: 2
placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant
Drug: placebo
placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant
No Intervention: 3
dental implant, calcium 1000mg and Vitamin D 800 IU daily



Primary Outcome Measures :
  1. Dental CT [ Time Frame: baseline, and 3,6,12 months after baseline ]


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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727493


Contacts
Contact: Dieter Felsenberg, Prof. Dr. +490384453046 dieter.felsenberg@charite.de
Contact: Hendrikje Boerst, Dipl. Wiss org. +490384454745 hendrikje.boerst@charite.de

Locations
Germany
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Dieter Felsenberg, Prof. Dr.    +493084453046      
Contact: Hendrikje Boerst, Dipl. Wiss. org.    +493084454745    hendrikje.boerst@charite.de   
Principal Investigator: Dieter Felsenberg, Prof. Dr.         
Sub-Investigator: Anton ° Friedman, Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Chair: Dieter Felsenberg, Prof. D.r Leader of the center for muscle and bone research, Charité

Responsible Party: Prof. Dr. med. Dieter Felsenberg, Center for Muscle and Bone Research
ClinicalTrials.gov Identifier: NCT00727493     History of Changes
Other Study ID Numbers: OPOZAHN
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: August 4, 2008
Last Verified: August 2008

Keywords provided by Charite University, Berlin, Germany:
osteoporosis,
bisphosphonate
therapy
dental implant

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Alendronate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents