FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)

Study Overview
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Brief Summary
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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).

Official Title
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Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of FOSAMAX PLUS and FOSAMAX PLUS D in Usual Practice

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: FOSAMAX PLUS
* Drug: FOSAMAX PLUS D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are treated with FOSAMAX PLUS / FOSAMAX PLUS D within label for the first time Exclusion Criteria: Participants who have a contraindication to FOSAMAX PLUS / FOSAMAX PLUS D according to the current local label

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FOSAMAX PLUS or FOSAMAX PLUS D<br>Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg/2800 IU) or FOSAMAX PLUS D (70 mg/5600 IU). | Drug: FOSAMAX PLUS<br>* Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly.<br>Drug: FOSAMAX PLUS D<br>* Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: death or was life-threatening prolonged an existing inpatient hospitalization a persistent or significant disability/ incapacity a congenital anomaly/ birth defect a significant medical situation, other important medical event based upon appropriate medical judgment of the investigator | 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 | 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) |