Suspended

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

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What is being tested

alendronate once weekly 70mg

+ placebo

Drug
Who is being recruted

Bone Diseases+3

+ Bone Diseases, Metabolic

+ Metabolic Diseases

From 60 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorCharite University, Berlin, Germany
Study ContactDieter Felsenberg, Prof. Dr.More contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

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

Official TitleEvaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis
Principal SponsorCharite University, Berlin, Germany
Study ContactDieter Felsenberg, Prof. Dr.More contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 60 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosis

Criteria

4 inclusion criteria required to participate
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)

6 exclusion criteria prevent from participating
Pathological findings in the jaw bone

Chronic inflammatory rheumatoid disease

Bisphosphonate treatments during the last 12 months

Inflammatory or metabolic bone disease, excluding osteoporosis

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant

Group II

Placebo
placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin

Berlin, GermanyOpen Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin in Google Maps
SuspendedOne Study Center