Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
NCT ID: NCT00693667
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2008-02-29
2011-07-31
Brief Summary
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The 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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A
Placebo
PH3
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.
B
250 mg active ingredient
PH3
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.
C
500 mg active ingredient
PH3
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.
D
750 mg active ingredient
PH3
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.
Interventions
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PH3
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.
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. The lumbar vertebral BMD T-score is between -1and -2.5 SD.
4. The body mass index (BMI) is between 19 and 29 kg/m2.
5. Completed informed consent and signed informed consent form.
Exclusion Criteria
2. Has taken drug therapy for osteoporosis within the previous six months (excluding calcium supplements) prior to this study.
3. 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.
4. Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL \~ 66.1 pg/mL).
5. Patients with fracture history.
6. 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.
40 Years
60 Years
FEMALE
No
Sponsors
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PhytoHealth Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Hsiang Tai Chao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Taipei Veteran General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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93-EC-17-A-17-I1-0034
Identifier Type: -
Identifier Source: secondary_id
PH-CP011
Identifier Type: -
Identifier Source: org_study_id
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