Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: PH3

• Registration Number: NCT00693667
• Lead Sponsor: PhytoHealth Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	PH3	Placebo
C	PH3	500 mg active ingredient
B	PH3	250 mg active ingredient
D	PH3	750 mg active ingredient

Primary Outcome Measures

Name	Time	Method
Biochemical Markers	four weeks

Secondary Outcome Measures

Name	Time	Method
Bone Densitometry	four weeks

Trial Locations

Locations (1)

Taipei Veteran General Hospital; 🇨🇳 Taipei, Taiwan