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

Primary outcomes

1. Number of Participants With Serious Adverse Events

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

   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

2. Number of Participants With Unexpected Adverse Events

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

   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.

3. Number of Participants With Non-Serious AEs

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

   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.

4. Number of Participants With Improved, Unchanged, or Worsened Disease

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

   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".

5. Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment

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

   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.

6. Change From Baseline in Serum Osteocalcin at End of Treatment

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

   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.

7. Change From Baseline in Urine Deoxypyridinoline at End of Treatment

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

   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.

8. Change From Baseline in Alkaline Phosphatase at End of Treatment

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

   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.