## Protocol Section
### Identification Module
**NCT ID:** NCT01065779

**Brief Title:** FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)

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

#### Organization Study ID Info
**ID:** 0217A-267
#### Organization
**Class:** INDUSTRY
**Full Name:** Organon and Co
#### Secondary ID Infos
**ID:** 2010_007
### Status Module
#### Completion Date
**Date:** 2010-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-03

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2011-09-13

**Type:** ESTIMATED

**Results First Submit Date:** 2011-06-21

**Results First Submit QC Date:** 2011-08-09

#### Start Date
**Date:** 2006-03

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2010-02-09
**Type:** ESTIMATED
**Study First Submit Date:** 2010-02-08
**Study First Submit QC Date:** 2010-02-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Organon and Co

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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).

### Conditions Module

**Conditions:**

- Osteoporosis

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 880

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg/2800 IU) or FOSAMAX PLUS D (70 mg/5600 IU).

**Intervention Names:**

- Drug: FOSAMAX PLUS

- Drug: FOSAMAX PLUS D

**Label:** FOSAMAX PLUS or FOSAMAX PLUS D

### Interventions

#### Intervention 1

**Arm Group Labels:**

- FOSAMAX PLUS or FOSAMAX PLUS D

**Description:** Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly.

**Name:** FOSAMAX PLUS

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- FOSAMAX PLUS or FOSAMAX PLUS D

**Description:** Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly.

**Name:** FOSAMAX PLUS D

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Number of Participants With Serious Adverse Events

**Time Frame:** Up to ~ 16 weeks and 14 days after treatment discontinuation

**Description:** 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.

**Measure:** Number of Participants With Unexpected Adverse Events

**Time Frame:** Up to ~ 16 weeks and 14 days after treatment discontinuation

**Description:** 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.

**Measure:** Number of Participants With Non-Serious AEs

**Time Frame:** Up to ~ 16 weeks and 14 days after treatment discontinuation

**Description:** 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".

**Measure:** Number of Participants With Improved, Unchanged, or Worsened Disease

**Time Frame:** Baseline and end of Treatment (Up to ~ 16 weeks)

**Description:** 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.

**Measure:** Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment

**Time Frame:** Baseline and End of Treatment (Up to ~ 16 weeks)

**Description:** 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.

**Measure:** Change From Baseline in Serum Osteocalcin at End of Treatment

**Time Frame:** Baseline and End of Treatment (Up to ~ 16 weeks)

**Description:** 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.

**Measure:** Change From Baseline in Urine Deoxypyridinoline at End of Treatment

**Time Frame:** Baseline and End of Treatment (Up to ~ 16 weeks)

**Description:** 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.

**Measure:** Change From Baseline in Alkaline Phosphatase at End of Treatment

**Time Frame:** Baseline and End of Treatment (Up to ~ 16 weeks)

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Medical Monitor

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001851

- Term: Bone Diseases, Metabolic

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12947

- Name: Osteoporosis

- Relevance: HIGH

- As Found: Osteoporosis

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5130

- Name: Bone Diseases, Metabolic

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010024

- Term: Osteoporosis

### Intervention Browse Module - Ancestors

- ID: D000050071

- Term: Bone Density Conservation Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: LOW

- As Found: Unknown

- ID: M6003

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M21353

- Name: Alendronate

- Relevance: HIGH

- As Found: Baclofen

- ID: T442

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: T479

- Name: Vitamin D3

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019386

- Term: Alendronate

### Misc Info Module

#### Removed Countries

- Country: Korea, Republic of

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety evaluation was performed in participants who took at least one dose of study medication and completed \> 1 follow up visit.

#### Event Groups

**Group ID:** EG000

**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D

**Description:** 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.

**ID:** EG000

**Other Num at Risk:** 798

**Serious Number At Risk:** 798

**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D

**Frequency Threshold:** 5

**Time Frame:** Up to ~ 16 weeks and 14 days after treatment discontinuation.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 880

**Units:** Participants

### Group

**ID:** BG000

**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D

**Description:** 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.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.05

**Value:** 67.12

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 741

**Class Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 57

**Class Title:** Male

#### Measurement

**Group ID:** BG000

**Value:** 82

**Class Title:** Excluded from Analysis

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Sex/Gender, Customized
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** ClinicalTrialsDisclosure@merck.com
**Organization:** Merck Sharp & Dohme Corp
**Title:** Senior Vice President, Global Clinical Development
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 549
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 239
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.48
- **Upper Limit:** 
- **Value:** 1.73
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.32
- **Upper Limit:** 
- **Value:** 0.69
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.83
- **Upper Limit:** 
- **Value:** 1.03
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 37.58
- **Upper Limit:** 
- **Value:** -16.36
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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
**Parameter Type:** NUMBER
**Population Description:** Safety evaluation was performed in participants who took at least one dose of study medication and completed \> 1 follow up visit.
**Reporting Status:** POSTED
**Time Frame:** Up to ~ 16 weeks and 14 days after treatment discontinuation
**Title:** Number of Participants With Serious Adverse Events
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
#### Outcome Measure 2
**Description:** 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.
**Parameter Type:** NUMBER
**Population Description:** Safety evaluation was performed in participants who took at least one dose of study medication and completed \> 1 follow up visit.
**Reporting Status:** POSTED
**Time Frame:** Up to ~ 16 weeks and 14 days after treatment discontinuation
**Title:** Number of Participants With Unexpected Adverse Events
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
#### Outcome Measure 3
**Description:** 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.
**Parameter Type:** NUMBER
**Population Description:** Safety evaluation was performed in participants who took at least one dose of study medication and completed \> 1 follow up visit.
**Reporting Status:** POSTED
**Time Frame:** Up to ~ 16 weeks and 14 days after treatment discontinuation
**Title:** Number of Participants With Non-Serious AEs
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
#### Outcome Measure 4
**Description:** 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".
**Parameter Type:** NUMBER
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Baseline and end of Treatment (Up to ~ 16 weeks)
**Title:** Number of Participants With Improved, Unchanged, or Worsened Disease
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
#### Outcome Measure 5
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Baseline and End of Treatment (Up to ~ 16 weeks)
**Title:** Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment
**Type:** PRIMARY
**Unit of Measure:** ng/mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
#### Outcome Measure 6
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Baseline and End of Treatment (Up to ~ 16 weeks)
**Title:** Change From Baseline in Serum Osteocalcin at End of Treatment
**Type:** PRIMARY
**Unit of Measure:** ng/mL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
#### Outcome Measure 7
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Baseline and End of Treatment (Up to ~ 16 weeks)
**Title:** Change From Baseline in Urine Deoxypyridinoline at End of Treatment
**Type:** PRIMARY
**Unit of Measure:** nmol/mmol
##### Group
**Description:** 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.
**ID:** OG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
#### Outcome Measure 8
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Baseline and End of Treatment (Up to ~ 16 weeks)
**Title:** Change From Baseline in Alkaline Phosphatase at End of Treatment
**Type:** PRIMARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 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.
**ID:** OG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
### Participant Flow Module
#### Group
**Description:** 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.
**ID:** FG000
**Title:** FOSAMAX PLUS/ FOSAMAX PLUS D
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Duplicate Investigation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Investigation Before Contract Date
###### Reason
**Group ID:** FG000
**Number of Subjects:** 37
##### Withdraw
**Type:** Non-enrollment Period Administration
###### Reason
**Group ID:** FG000
**Number of Subjects:** 10
##### Withdraw
**Type:** Not Administered With Study Drug
###### Reason
**Group ID:** FG000
**Number of Subjects:** 17
##### Withdraw
**Type:** Failed to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 10
##### Withdraw
**Type:** Inclusion Criteria Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 880
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 798
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 82
**Has Results:** True