Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 6:45 AM
Study NCT ID:
NCT00409032
Status:
COMPLETED
Last Update Posted:
2009-10-23
First Post:
2006-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-response Study With Strontium Malonate in Postmenopausal Women
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-22', 'studyFirstSubmitDate': '2006-12-07', 'studyFirstSubmitQcDate': '2006-12-07', 'lastUpdatePostDateStruct': {'date': '2009-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CTX-1'}], 'secondaryOutcomes': [{'measure': 'Other bio markers, BMD'}]}, 'conditionsModule': {'keywords': ['osteoporosis', 'BMD', 'CTX', 'Post menopausal', 'strontium', 'bone turnover', 'clinical development'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.osteologix.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment.', 'detailedDescription': '275 post menopausal women are treated with either 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 g Protelos® or placebo.\n\nPatients are treated for 12 weeks. A follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment CTX-1 activity.\n\nApart from S-CTS-1 also response on other bio markers are evaluated as well as BMD.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women (at least 12 months since last menstruation).\n* BMD (L2-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5).\n* 50 years of age.\n* BMI\\<30 kg/m2.\n* Total S-Ca level within normal range.\n* Ability to read and understand the information given.\n* The patient has signed an informed consent form according to ICH E6 and local requirements before any study specific procedure is carried out.\n* Ability to comply with study procedures.\n\nExclusion Criteria:\n\n* History of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age).\n* History of alcohol or drug abuse.\n* Metabolic bone disease (e.g. pagets disease, bone cancer).\n* History of VTE/DVT.\n* History of kidney transplant.\n* Bilateral oophorectomy.\n* Relevant and treated reduced kidney or liver function.\n* Any malignancy within the last 5 years (except basal cell carcinoma)\n* Any chronic condition likely to affect absorption (e.g. Crohns disease, gluten enteropathy).\n* Known genetic pre-disposition to VTE/DVT\n* Known hypersensitivity to any of the active substances or excipients.\n* 25-OH-vitamin D level below 25 nmol/L\n* Any previous treatment with bisphosphonates, Strontium or fluoride.\n* Treatment during the last 3 months affecting calcium balance or bone metabolism (e.g. thiazides, corticosteroids, calcitonin, HRT, SERMs, PTH, phosphorus).\n* Treatment during the last week with tetracycline, ciprofloxacin or loop diuretics.\n* PTH out of normal range\n* Use of any drug known to influence the coagulation process (aspirin and other NSAID allowed)\n* Prothrombin time out of normal range (sec or INR)\n* Inclusion in another clinical study within 30 days before randomization or during this study'}, 'identificationModule': {'nctId': 'NCT00409032', 'briefTitle': 'A Dose-response Study With Strontium Malonate in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Osteologix'}, 'officialTitle': 'A Dose-response Study With Strontium Malonate in Postmenopausal Women. A 12 Week, Multi National, Double Blind, Randomized, 5 Arms, Parallel Group Placebo Controlled Open Label Active Controlled, Phase II Study With 3 Dose Levels of Strontium Malonate and Protelos Within Post Menopausal Women With a BMDT-score Below -1', 'orgStudyIdInfo': {'id': 'NBS-C03-OP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Strontium malonate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'PhaseOneTrials', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Northwood', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Medinova Clinic', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'CF14 5GJ', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Synexus Wales Clinical Research Centre', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'G81 2DR', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Synexus Scotland Clinical Research Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'RG2 7AG', 'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Synexus Limited Reading Clinical Research Centre', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'University of Sheffield', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'L22 0LG', 'city': 'Waterloo', 'country': 'United Kingdom', 'facility': 'Synexus Crosby Clinical Research Centre', 'geoPoint': {'lat': 53.47454, 'lon': -3.03017}}, {'zip': 'WN1 1XX', 'city': 'Wigan', 'country': 'United Kingdom', 'facility': 'Synexus Wigan Clinical Research Centre', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}], 'overallOfficials': [{'name': 'Richard Eastell, Professor, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osteologix', 'class': 'INDUSTRY'}}}}