Status:
COMPLETED
Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
Lead Sponsor:
PhytoHealth Corporation
Conditions:
Osteoporosis
Eligibility:
FEMALE
40-60 years
Phase:
PHASE2
Brief Summary
The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis. The secondary objectives are to identify the optimal dosage for sub...
Eligibility Criteria
Inclusion
- Women 40-60 years of age.
- 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).
- The lumbar vertebral BMD T-score is between -1and -2.5 SD.
- The body mass index (BMI) is between 19 and 29 kg/m2.
- Completed informed consent and signed informed consent form.
Exclusion
- 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.
- Has taken drug therapy for osteoporosis within the previous six months (excluding calcium supplements) prior to this study.
- 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.
- Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL \~ 66.1 pg/mL).
- Patients with fracture history.
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00693667
Start Date
February 1 2008
End Date
July 1 2011
Last Update
April 1 2021
Active Locations (1)
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1
Taipei Veteran General Hospital
Taipei, Taiwan