Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT03435094
Status:
UNKNOWN
Last Update Posted:
2020-12-03
First Post:
2018-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 's-CTX', 'timeFrame': 'Change at 6 months, 12 months, 18 months after treatment start', 'description': 'Decrease in the rate of the bone resorption marker s-CTX'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis, Postmenopausal']}, 'descriptionModule': {'briefSummary': 'Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Post-menopausal women with osteoporosis, on treatment with Fosamax® or Binosto® for 6-8 months and who will be continued to be treated for a minimum of 12 months, with available BTMs, biochemistry and DXA at the initiation are to be offered participation in the study at the discretion of the treating physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal women (at least 5 years after natural / surgical menopause).\n* Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months.\n* Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment.\n* Ability to sign an informed patient consent\n\nExclusion Criteria:\n\n* Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg.\n* Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption\n* Metabolic or cancer bone disease\n* Contra-indications to bisphosphonates according to product labelling\n* Known or suspected allergy to study product(s) or related products\n* Inability to sign an informed consent\n* Previous participation in this study'}, 'identificationModule': {'nctId': 'NCT03435094', 'briefTitle': 'Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Labatec Pharma SA'}, 'officialTitle': 'A Non-interventional Two-arm Two-centre, Retrospective/Prospective Study to Compare the Effect of Alendronate 70mg Formulation (Tablet vs Effervescent Tablet) on Bone Turnover Markers and Patient Reported Outcomes', 'orgStudyIdInfo': {'id': 'LAB-BIN-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fosamax®', 'description': '1 group will be treated with alendronate 70 mg tablets (Fosamax®)', 'interventionNames': ['Drug: Fosamax 70Mg Tablet']}, {'label': 'Binosto®', 'description': '1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®)', 'interventionNames': ['Drug: Binosto 70Mg Effervescent Tablet']}], 'interventions': [{'name': 'Binosto 70Mg Effervescent Tablet', 'type': 'DRUG', 'description': 'Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.', 'armGroupLabels': ['Binosto®']}, {'name': 'Fosamax 70Mg Tablet', 'type': 'DRUG', 'description': 'Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.', 'armGroupLabels': ['Fosamax®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4055', 'city': 'Basel', 'state': 'Canton of Basel-City', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christian Meier, Prof', 'role': 'CONTACT'}], 'facility': 'Endokrinologische Praxis & Labor', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Serge Ferrari, Prof', 'role': 'CONTACT'}], 'facility': 'Hôpital Universitaire de Genève, Service des maladies osseuses', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Aurélie TIREFORD, PharmD', 'role': 'CONTACT', 'email': 'aurelie.tireford@labatec.com', 'phone': '+41 22 593 78 54'}], 'overallOfficials': [{'name': 'Aurélie TIREFORD, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Labatec Pharma SA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Labatec Pharma SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}