Osteoporosis and Dental Implant

NCT ID: NCT00727493

Last Updated: 2008-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-04-30

Brief Summary

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

Detailed Description

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Conditions

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Osteoporosis

Keywords

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osteoporosis, bisphosphonate therapy dental implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

alendronate once weekly 70mg

Intervention Type DRUG

alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant

2

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

3

dental implant, calcium 1000mg and Vitamin D 800 IU daily

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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alendronate once weekly 70mg

alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Center for Muscle and Bone Research

Principal Investigators

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Dieter Felsenberg, Prof. D.r

Role: STUDY_CHAIR

Leader of the center for muscle and bone research, Charité

Locations

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

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Dieter Felsenberg, Prof. Dr.

Role: CONTACT

Phone: +490384453046

Email: [email protected]

Hendrikje Boerst, Dipl. Wiss org.

Role: CONTACT

Phone: +490384454745

Email: [email protected]

Facility Contacts

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Dieter Felsenberg, Prof. Dr.

Role: primary

Hendrikje Boerst, Dipl. Wiss. org.

Role: backup

Other Identifiers

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OPOZAHN

Identifier Type: -

Identifier Source: org_study_id