Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women (PH3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693667
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : November 4, 2011
Information provided by (Responsible Party):
PhytoHealth Corporation

February 19, 2008
June 9, 2008
November 4, 2011
February 2008
July 2011   (Final data collection date for primary outcome measure)
Biochemical Markers [ Time Frame: four weeks ]
Biochemical Markers [ Time Frame: two weeks ]
Complete list of historical versions of study NCT00693667 on Archive Site
Bone Densitometry [ Time Frame: four weeks ]
Same as current
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Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
A Phase II, Double-Blind, Randomized, Placebo-controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
  • Placebo Comparator: A
    Intervention: Drug: PH3
  • Active Comparator: B
    250 mg active ingredient
    Intervention: Drug: PH3
  • Active Comparator: C
    500 mg active ingredient
    Intervention: Drug: PH3
  • Active Comparator: D
    750 mg active ingredient
    Intervention: Drug: PH3
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2011
July 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
40 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
PhytoHealth Corporation
PhytoHealth Corporation
Not Provided
Principal Investigator: Hsiang Tai Chao, Ph.D Taipei Veterans General Hospital, Taiwan
PhytoHealth Corporation
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP