OsteoporosisPhase 2PH3NCT00693667
Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
A Phase 2 study testing PH3 in people with Osteoporosis, run by PhytoHealth Corporation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- PH3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2008to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Osteoporosis
- Being tested
- PH3
- Keywords
- osteoporosis, postmenopausal women, botanical drug
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH3Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo Receives: Drug: PH3 |
| B | Active comparator | 250 mg active ingredient Receives: Drug: PH3 |
| C | Active comparator | 500 mg active ingredient Receives: Drug: PH3 |
| D | Active comparator | 750 mg active ingredient Receives: Drug: PH3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Markers
Measured: four weeks
Secondary outcomes (1)
Bone Densitometry
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsiang Tai Chao, Ph.D, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693667
- Sponsor's protocol ID
- PH-CP011
- Other IDs
- 93-EC-17-A-17-I1-0034
- Acronym
- PH3
- Status last verified
- Mar 2021
- First submitted
- 19 Feb 2008
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Randomized, Placebo-controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00693667
- Acronym / sponsor ID
- PH3 / PH-CP011
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, postmenopausal women, botanical drug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PH3Placebo |
| B | Active comparator | Drug: PH3250 mg active ingredient |
| C | Active comparator | Drug: PH3500 mg active ingredient |
| D | Active comparator | Drug: PH3750 mg active ingredient |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PH3Each 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. | Drug | A, B, C, D |
Primary outcome
Biochemical Markers
Time frame: four weeks
1 secondary outcome
Bone Densitometry
Time frame: four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiang Tai Chao, Ph.D principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PH3 in people with Osteoporosis, run by PhytoHealth Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Markers (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.