Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis

Study Overview
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Brief Summary
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The overall objective of the study is to compare treatment with the ASTRA TECH Implant System, OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. The hypothesis is that there will be no difference in marginal bone level alterations between the two groups.

Official Title
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An Open, Prospective, Non-randomized, Controlled, Multicenter Study to Evaluate Clinical Outcome of the ASTRA TECH Implant System, OsseoSpeed™ Implant in Women Over 60 Years of Age With Osteoporosis/Osteopenia

Conditions
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Postmenopausal Osteoporosis, Osteopenia, Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: OsseoSpeed™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent Postmenopausal women aged 60 years and over In need of 2-8 implants in maxilla A history of edentulism in the area of implant treatment of at least 6 months. A Bone Mineral Density (BMD) value suitable either for group A or group B: Group A (Osteoporosis/osteopenia): BMD at least 2 standard deviations (SD) below mean peak bone density of young adults for the spine and total hip (T-score = -2 SD or less). Absolute values (g/cm2) will be used. Group B (Control): BMD not more than 1 standard deviation below mean peak bone density of young adults for the spine and total hip (T-score = -1 SD or more). Absolute values (g/cm2) will be used. Exclusion Criteria: Unlikely to be able to comply with study procedures, as judged by the investigator. Untreated, uncontrolled caries and/or periodontal disease Known or suspected current malignancy History of chemotherapy within 5 years prior to surgery History of radiation in the head and neck region History of other metabolic bone diseases, e.g. Paget's disease, hyperparathyroidism, fibrous dysplasia or osteomalacia A medical history that makes implant insertion unfavourable Need for systemic corticosteroids Current or previous use of intravenous bisphosphonates (esp. zoledronic acid) Current or previous use of oral bisphosphonates History of bone grafting and/or sinus lift in the planned implant area Current need for bone grafting and/or sinus lift in the planned implant area Present alcohol and/or drug abuse Involvement in the planning and conduct of the study (applies to both Astra Tech AB staff or staff at the study site) Previous enrolment in the present study. Participation in a clinical study during the last 6 months.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group-A, Osteoporosis/osteopenia<br>Patients with osteoporosis/osteopenia. | Device: OsseoSpeed™<br>* ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm<br>|
| Experimental: Group-B, Control<br>Control (non-osteoporotic/-osteopenic patients). | Device: OsseoSpeed™<br>* ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone Level Alterations | Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at time of loading of the permanent restoration (baseline). | Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading. |