Osteoporosis
Conditions
Keywords
osteoporosis, postmenopausal women, botanical drug
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 subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.
Interventions
DRUGPH3
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.
Sponsors
PhytoHealth Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Women 40-60 years of age. 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
1. 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical Markers | four weeks |
Secondary
| Measure | Time frame |
|---|---|
| Bone Densitometry | four weeks |
Countries
Taiwan
Outcome results
None listed