Osteoporosis and Dental Implant (OPOZAHN)

Charité University Medicine Berlin

Status and phase: Unknown; Phase 4

Conditions: Osteoporosis

Treatments: Drug: alendronate once weekly 70mg; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00727493

OPOZAHN

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: Female

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: alendronate once weekly 70mg

2

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

3

No Intervention group

Description:

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