Study Evaluating OsseoSpeed™ Implants in the Upper Jaw of Women With Osteoporosis - Full Text View

Sponsored by:	Astra Tech AB
Information provided by:	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00745121

Purpose

The overall objective of the study is to compare treatment with the 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.

Condition	Intervention
Postmenopausal Osteoporosis Osteopenia Jaw, Edentulous, Partially	Device: OsseoSpeed™

MedlinePlus related topics: Osteoporosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	An Open, Prospective, Non-Randomized, Controlled, Multicenter Study to Evaluate Clinical Outcome of the Astra Tech OsseoSpeed™ Implant in Women Over 60 Years of Age With Osteoporosis/Osteopenia

Further study details as provided by Astra Tech AB:

Primary Outcome Measures:

Marginal bone level alterations [ Time Frame: 6, 12, 24, 36, 48 and 60 months after insertion of permanent prosthesis ] [ Designated as safety issue: No ]

Estimated Enrollment:	104
Study Start Date:	August 2008
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Patients with osteoporosis/osteopenia.	Device: OsseoSpeed™ OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm
B: Experimental Control (non-osteoporotic/-osteopenic patients).	Device: OsseoSpeed™ OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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 BMD value suitable either for group A or group B:
Group A (Osteoporosis/osteopenia): BMD at least 2 standard deviations below mean peak bone density of young adults for the spine and total hip (T-score = -2SD 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 = -1SD 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745121

Contacts

Contact: Anna Rydberg

+46317763000

Locations

Belgium
Department of Periodontology, Faculty of Medicine, Catholic University of Leuven	Recruiting
Leuven, Belgium, B-3000
Germany
Zahnklinik	Not yet recruiting
Würzburg, Germany, DE-97070
Sweden
Department of Oral and Maxillofacial Surgery, Gothenburg University	Not yet recruiting
Gothenburg, Sweden, SE-405 30

Sponsors and Collaborators

Astra Tech AB

Investigators

Principal Investigator:

Marc Quirynen, Prof., Dr.

Katholieke Universiteit Leuven

More Information

Responsible Party:	Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research )
Study ID Numbers:	YA-OSS-0007
Study First Received:	September 2, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00745121
Health Authority:	Belgium: Institutional Review Board; Germany: Ethics Commission; Sweden: Regional Ethical Review Board

Study placed in the following topic categories:

Mouth Diseases
Mouth, Edentulous
Tooth Diseases
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis

Bone Diseases, Metabolic
Stomatognathic Diseases
Jaw, Edentulous
Bone Diseases
Jaw, Edentulous, Partially

Additional relevant MeSH terms:

Jaw Diseases

ClinicalTrials.gov processed this record on January 16, 2009