Osteoporosis and Dental Implant

Osteoporosis Clinical Trial

— OPOZAHN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00727493
• Other study ID #: OPOZAHN
• Status: Recruiting
• Phase: Phase 4
• First received: July 31, 2008
• Last updated: August 1, 2008
• Start date: January 2004
• Est. completion date: April 2010

Study information

• Verified date: August 2008
• Source: Charite University, Berlin, Germany
• Contact: Dieter Felsenberg, Prof. Dr.
• Phone: +490384453046
• Email: dieter.felsenberg[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• alendronate once weekly 70mg
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
• placebo
placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant

Locations

Country	Name	City	State
Germany	Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental CT		baseline, and 3,6,12 months after baseline	Yes