Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

PhytoHealth

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: PH3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00693667

93-EC-17-A-17-I1-0034

PH-CP011

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 4 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: PH3

B

Active Comparator group

Description:

250 mg active ingredient

Treatment:

Drug: PH3

C

Active Comparator group

Description:

500 mg active ingredient

Treatment:

Drug: PH3

D

Active Comparator group

Description:

750 mg active ingredient

Treatment:

Drug: PH3