Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT00693667
First received: February 19, 2008
Last updated: November 3, 2011
Last verified: November 2011

February 19, 2008
November 3, 2011
February 2008
July 2011   (final data collection date for primary outcome measure)
Biochemical Markers [ Time Frame: four weeks ] [ Designated as safety issue: No ]
Biochemical Markers [ Time Frame: two weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00693667 on ClinicalTrials.gov Archive Site
Bone Densitometry [ Time Frame: four weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Osteoporosis
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
    Placebo
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
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.
Female
40 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00693667
PH-CP011, 93-EC-17-A-17-I1-0034
No
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