Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-02 @ 7:53 AM
Study NCT ID:
NCT00727493
Status:
UNKNOWN
Last Update Posted:
2008-08-04
First Post:
2008-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoporosis and Dental Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-08-01', 'studyFirstSubmitDate': '2008-07-31', 'studyFirstSubmitQcDate': '2008-08-01', 'lastUpdatePostDateStruct': {'date': '2008-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental CT', 'timeFrame': 'baseline, and 3,6,12 months after baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoporosis,', 'bisphosphonate', 'therapy', 'dental implant'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women \\> 2 years after menopause\n* Age between 60 and 75 years\n* Possibility to insert a dental implant\n* Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group)\n\nExclusion Criteria:\n\n* Pathological findings in the jaw bone\n* Chronic inflammatory rheumatoid disease\n* Bisphosphonate treatments during the last 12 months\n* Inflammatory or metabolic bone disease, excluding osteoporosis\n* Systemic corticosteroid treatments of more than one month within previous 12 months\n* Severe diseases with life expectancy less than one year or expectation of rapid worsening within one year'}, 'identificationModule': {'nctId': 'NCT00727493', 'acronym': 'OPOZAHN', 'briefTitle': 'Osteoporosis and Dental Implant', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis', 'orgStudyIdInfo': {'id': 'OPOZAHN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant', 'interventionNames': ['Drug: alendronate once weekly 70mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant', 'interventionNames': ['Drug: placebo']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'dental implant, calcium 1000mg and Vitamin D 800 IU daily'}], 'interventions': [{'name': 'alendronate once weekly 70mg', 'type': 'DRUG', 'description': 'alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dieter Felsenberg, Prof. Dr.', 'role': 'CONTACT', 'phone': '+493084453046'}, {'name': 'Hendrikje Boerst, Dipl. Wiss. org.', 'role': 'CONTACT', 'email': 'hendrikje.boerst@charite.de', 'phone': '+493084454745'}, {'name': 'Dieter Felsenberg, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anton ° Friedman, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Dieter Felsenberg, Prof. Dr.', 'role': 'CONTACT', 'email': 'dieter.felsenberg@charite.de', 'phone': '+490384453046'}, {'name': 'Hendrikje Boerst, Dipl. Wiss org.', 'role': 'CONTACT', 'email': 'hendrikje.boerst@charite.de', 'phone': '+490384454745'}], 'overallOfficials': [{'name': 'Dieter Felsenberg, Prof. D.r', 'role': 'STUDY_CHAIR', 'affiliation': 'Leader of the center for muscle and bone research, Charité'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. med. Dieter Felsenberg', 'oldOrganization': 'Center for Muscle and Bone Research'}}}}