Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT00693667
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2008-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of PH3 for the Prevention of Osteoporosis 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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical Markers', 'timeFrame': 'four weeks'}], 'secondaryOutcomes': [{'measure': 'Bone Densitometry', 'timeFrame': 'four weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'postmenopausal women', 'botanical drug'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis.\n\nThe secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Women 40-60 years of age.\n2. Must be postmenopausal (0.5\\~5 years post cessation of menses) or ovariectomized or hysterectomy women who have documented elevated Follicle Stimulating Hormone FSH (\\>30mIU/ml) with low serum estradiol (\\<20 pg/ml).\n3. The lumbar vertebral BMD T-score is between -1and -2.5 SD.\n4. The body mass index (BMI) is between 19 and 29 kg/m2.\n5. Completed informed consent and signed informed consent form.\n\nExclusion Criteria:\n\n1. Have diseases which may affect bone metabolism, e. g., hyper-or hypocalcemia, hyperthyroidism, osteogenesis imperfecta, malignancy, chronic gastrointestinal disease, extensive Paget's disease, alcoholism, and renal or hepatic impairment.\n2. Has taken drug therapy for osteoporosis within the previous six months (excluding calcium supplements) prior to this study.\n3. Chronic or continued use of hormone replacement drugs or medications that may affect bone calcium metabolism, for example, phosphate-binding antacids, many diuretics, adrenal or anabolic steroids, heparin, anticonvulsants, fluoride in excess of 1 mg/day and supplements of vitamin D or A in excess of RDAs.\n4. Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL \\~ 66.1 pg/mL).\n5. Patients with fracture history.\n6. Patients who can not promise to keep from taking stimulant drinks (for example, coffee, tea, alcoholic drink, and Coke) that may cause loss of bone calcium, during the study period."}, 'identificationModule': {'nctId': 'NCT00693667', 'acronym': 'PH3', 'briefTitle': 'Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'PhytoHealth Corporation'}, 'officialTitle': 'A Phase II, Double-Blind, Randomized, Placebo-controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'PH-CP011'}, 'secondaryIdInfos': [{'id': '93-EC-17-A-17-I1-0034'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'Placebo', 'interventionNames': ['Drug: PH3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': '250 mg active ingredient', 'interventionNames': ['Drug: PH3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'description': '500 mg active ingredient', 'interventionNames': ['Drug: PH3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D', 'description': '750 mg active ingredient', 'interventionNames': ['Drug: PH3']}], 'interventions': [{'name': 'PH3', 'type': 'DRUG', 'description': 'Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. Three tablets per day will be taken orally before bedtime.', 'armGroupLabels': ['A', 'B', 'C', 'D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veteran General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hsiang Tai Chao, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PhytoHealth Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}