Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

NCT00693667 | Completed Phase 2

• 2 other identifiers: PH-CP01193-EC-17-A-17-I1-0034
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Keywords

osteoporosis; postmenopausal women; botanical drug

Outcome Measures

Primary Outcomes (1)

• Biochemical Markers

  four weeks

Secondary Outcomes (1)

• Bone Densitometry

  four weeks

Study Arms (4)

A

PLACEBO COMPARATOR

Placebo

Drug: PH3

B

ACTIVE COMPARATOR

250 mg active ingredient

Drug: PH3

C

ACTIVE COMPARATOR

500 mg active ingredient

Drug: PH3

D

ACTIVE COMPARATOR

750 mg active ingredient

Drug: PH3

Interventions

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.

A; B; C; D

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (1)

Taipei Veteran General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hsiang Tai Chao, Ph.D

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: June 9, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

TW (1)