Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

Osteoporosis Clinical Trial

— PH3  

Official title:

A Phase II, Double-Blind, Randomized, Placebo-controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693667
• Other study ID #: PH-CP011
• Secondary ID: 93-EC-17-A-17-I1
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: July 2011

Study information

• Verified date: March 2021
• Source: PhytoHealth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei Veteran General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
PhytoHealth Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical Markers		four weeks
Secondary	Bone Densitometry		four weeks