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Osteoporosis and Dental Implant (OPOZAHN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00727493
First received: July 31, 2008
Last updated: August 1, 2008
Last verified: August 2008
History of Changes
  Purpose

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 Intervention Phase
Osteoporosis
 Drug: alendronate once weekly 70mg
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Dental CT [ Time Frame: baseline, and 3,6,12 months after baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: January 2004
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 31, 2008
Last Updated: August 1, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013