Osteoporosis and Dental Implant (OPOZAHN)

August 1, 2008 updated by: Charite University, Berlin, Germany

Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis

The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
        • Contact:
          • Dieter Felsenberg, Prof. Dr.
          • Phone Number: +493084453046
        • Contact:
        • Principal Investigator:
          • Dieter Felsenberg, Prof. Dr.
        • Sub-Investigator:
          • Anton ° Friedman, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dental CT
Time Frame: baseline, and 3,6,12 months after baseline
baseline, and 3,6,12 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Chair: Dieter Felsenberg, Prof. D.r, Leader of the center for muscle and bone research, Charité

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 1, 2008

First Posted (Estimate)

August 4, 2008

Study Record Updates

Last Update Posted (Estimate)

August 4, 2008

Last Update Submitted That Met QC Criteria

August 1, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPOZAHN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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