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| ID | Type | Description | Link |
|---|---|---|---|
| 93-EC-17-A-17-I1-0034 |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Placebo |
|
| B | Active Comparator | 250 mg active ingredient |
|
| C | Active Comparator | 500 mg active ingredient |
|
| D | Active Comparator | 750 mg active ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Markers | four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Densitometry | four weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsiang Tai Chao, Ph.D | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veteran General Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| D009750 |
| Nutritional and Metabolic Diseases |