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Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
This study is currently recruiting participants.
Verified by PhytoHealth Corporation, August 2008
Sponsored by: PhytoHealth Corporation
Information provided by: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT00693667
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: PH3
Phase II

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • Biochemical Markers [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Densitometry [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator
Placebo
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.
B: Active Comparator
250 mg active ingredient
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.
C: Active Comparator
500 mg active ingredient
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.
D: Active Comparator
750 mg active ingredient
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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693667

Locations
Taiwan
Taipei Veteran General Hospital Recruiting
Taipei, Taiwan
Contact: Hui Chuan Huang     886-2-2545-3697 ext 314     huichuan@phytohealth.com.tw    
Contact: Hsiang Ling Ho     886-2-2545-3697 ext 319     irisho@phytohealth.com.tw    
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Hsiang Tai Chao, Ph.D Taipei Veterans General Hospital,Taiwan
  More Information

Responsible Party: PhytoHealth Corporation ( Hui-Chuan Huang/Project Manager )
Study ID Numbers: PH-CP011, 93-EC-17-A-17-I1-0034
Study First Received: February 19, 2008
Last Updated: August 13, 2008
ClinicalTrials.gov Identifier: NCT00693667  
Health Authority: United States: Food and Drug Administration;   Taiwan: Department of Health

Keywords provided by PhytoHealth Corporation:
osteoporosis
postmenopausal women
botanical drug

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009