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Completed

NCT Number: NCT00693667

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.

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Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Taipei Veteran General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women 40-60 years of age.
  • 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).
  • The lumbar vertebral BMD T-score is between -1and -2.5 SD.
  • The body mass index (BMI) is between 19 and 29 kg/m2.
  • Completed informed consent and signed informed consent form.

Exclusion criteria

  • 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.
  • Has taken drug therapy for osteoporosis within the previous six months (excluding calcium supplements) prior to this study.
  • 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.
  • Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL ~ 66.1 pg/mL).
  • Patients with fracture history.
  • 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.

Treatment and study plan

PH3

Drug

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.

Primary outcomes

  1. Biochemical Markers

    Time frame: four weeks

Secondary outcomes

  1. Bone Densitometry

    Time frame: four weeks

Sponsors and collaborators

Lead sponsor

PhytoHealth Corporation

Industry

Registry information

Official study title

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

Acronym: PH3

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2008
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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