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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_007 |
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This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety information according to the Re-examination Regulation for New Drugs.
Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800 IU) and FOSAMAX PLUS D (70 mg/5600 IU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOSAMAX PLUS or FOSAMAX PLUS D | Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg/2800 IU) or FOSAMAX PLUS D (70 mg/5600 IU). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOSAMAX PLUS | Drug | Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events | Number of participants that experienced Serious Adverse events (SAE). There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators. SAEs were considered serious if the event resulted in:
| Up to ~ 16 weeks and 14 days after treatment discontinuation |
| Number of Participants With Unexpected Adverse Events | Number of participants that experienced unexpected Adverse Events (AEs) regardless of whether or not the AE was considered related to the use of the product. There was no required routine visit scheduled for AE assessment. An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. | Up to ~ 16 weeks and 14 days after treatment discontinuation |
| Number of Participants With Non-Serious AEs | An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators. | Up to ~ 16 weeks and 14 days after treatment discontinuation |
| Number of Participants With Improved, Unchanged, or Worsened Disease |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | FOSAMAX PLUS/ FOSAMAX PLUS D | Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | FOSAMAX PLUS/ FOSAMAX PLUS D | Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events | Number of participants that experienced Serious Adverse events (SAE). There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators. SAEs were considered serious if the event resulted in:
| Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit. | Posted | Number | Participants | Up to ~ 16 weeks and 14 days after treatment discontinuation |
|
Up to ~ 16 weeks and 14 days after treatment discontinuation.
Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FOSAMAX PLUS/ FOSAMAX PLUS D | Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| FOSAMAX PLUS D | Drug | Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly. |
|
Evaluation of disease improvement was conducted in 3 categories of "improved", "unchanged", or "worsened". Changes in biochemical markers and vitamin D levels were reviewed before (baseline) and after treatment using statistical analyses to determine disease status, which was reported as either "improved", "unchanged", or "worsened". |
| Baseline and end of Treatment (Up to ~ 16 weeks) |
| Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment | For efficacy evaluation, changes in Serum 25-hydroxyvitamin D were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. | Baseline and End of Treatment (Up to ~ 16 weeks) |
| Change From Baseline in Serum Osteocalcin at End of Treatment | For efficacy evaluation, changes in Serum Osteocalcin were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. | Baseline and End of Treatment (Up to ~ 16 weeks) |
| Change From Baseline in Urine Deoxypyridinoline at End of Treatment | For efficacy evaluation, changes in Serum Deoxypyridinoline were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. | Baseline and End of Treatment (Up to ~ 16 weeks) |
| Change From Baseline in Alkaline Phosphatase at End of Treatment | For efficacy evaluation, changes in Serum Alkaline Phosphatase were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. | Baseline and End of Treatment (Up to ~ 16 weeks) |
| Not Administered With Study Drug |
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| Failed to Follow-up |
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| Inclusion Criteria Violation |
|
| years |
|
| Sex/Gender, Customized | Number | participants |
|
Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
|
|
| Primary | Number of Participants With Unexpected Adverse Events | Number of participants that experienced unexpected Adverse Events (AEs) regardless of whether or not the AE was considered related to the use of the product. There was no required routine visit scheduled for AE assessment. An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. | Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit. | Posted | Number | Participants | Up to ~ 16 weeks and 14 days after treatment discontinuation |
|
|
|
| Primary | Number of Participants With Non-Serious AEs | An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators. | Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit. | Posted | Number | Participants | Up to ~ 16 weeks and 14 days after treatment discontinuation |
|
|
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| Primary | Number of Participants With Improved, Unchanged, or Worsened Disease | Evaluation of disease improvement was conducted in 3 categories of "improved", "unchanged", or "worsened". Changes in biochemical markers and vitamin D levels were reviewed before (baseline) and after treatment using statistical analyses to determine disease status, which was reported as either "improved", "unchanged", or "worsened". | Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. | Posted | Number | Participants | Baseline and end of Treatment (Up to ~ 16 weeks) |
|
|
|
| Primary | Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment | For efficacy evaluation, changes in Serum 25-hydroxyvitamin D were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. | Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included. | Posted | Mean | Standard Deviation | ng/mL | Baseline and End of Treatment (Up to ~ 16 weeks) |
|
|
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| Primary | Change From Baseline in Serum Osteocalcin at End of Treatment | For efficacy evaluation, changes in Serum Osteocalcin were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. | Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included. | Posted | Mean | Standard Deviation | ng/mL | Baseline and End of Treatment (Up to ~ 16 weeks) |
|
|
|
| Primary | Change From Baseline in Urine Deoxypyridinoline at End of Treatment | For efficacy evaluation, changes in Serum Deoxypyridinoline were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. | Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included. | Posted | Mean | Standard Deviation | nmol/mmol | Baseline and End of Treatment (Up to ~ 16 weeks) |
|
|
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| Primary | Change From Baseline in Alkaline Phosphatase at End of Treatment | For efficacy evaluation, changes in Serum Alkaline Phosphatase were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. | Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included. | Posted | Mean | Standard Deviation | mg/dL | Baseline and End of Treatment (Up to ~ 16 weeks) |
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| 0 |
| 798 |
| 0 |
| 798 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| Title | Measurements |
|---|---|
|