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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
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II, Double-Blind, Randomized, Placebo-controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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 ]

Enrollment: 92
Study Start Date: February 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
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.
Active Comparator: B
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.
Active Comparator: C
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.
Active Comparator: D
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
Taipei, Taiwan
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Hsiang Tai Chao, Ph.D Taipei Veterans General Hospital,Taiwan
  More Information

No publications provided

Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT00693667     History of Changes
Other Study ID Numbers: PH-CP011, 93-EC-17-A-17-I1-0034
Study First Received: February 19, 2008
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by PhytoHealth Corporation:
osteoporosis
postmenopausal women
botanical drug

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 18, 2013