Osteoporosis
Conditions
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).
Interventions
DRUGFOSAMAX PLUS
Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly.
DRUGFOSAMAX PLUS D
Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly.
Sponsors
Organon and Co
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events | 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 |
| Number of Participants With Unexpected Adverse Events | 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. |
| Number of Participants With Non-Serious AEs | 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. |
| Number of Participants With Improved, Unchanged, or Worsened Disease | 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. |
| Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment | 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. |
| Change From Baseline in Serum Osteocalcin at End of Treatment | 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. |
| Change From Baseline in Urine Deoxypyridinoline at End of Treatment | 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. |
| Change From Baseline in Alkaline Phosphatase at End of Treatment | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 880 |
| Total | 880 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Duplicate Investigation | 1 |
| Overall Study | Failed to Follow-up | 10 |
| Overall Study | Inclusion Criteria Violation | 7 |
| Overall Study | Investigation Before Contract Date | 37 |
| Overall Study | Non-enrollment Period Administration | 10 |
| Overall Study | Not Administered With Study Drug | 17 |
Baseline characteristics
| Characteristic | FOSAMAX PLUS/ FOSAMAX PLUS D |
|---|---|
| Age, Continuous | 67.12 years STANDARD_DEVIATION 9.05 |
| Sex/Gender, Customized Excluded from Analysis | 82 participants |
| Sex/Gender, Customized Female | 741 participants |
| Sex/Gender, Customized Male | 57 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 798 |
| serious Total, serious adverse events | 0 / 798 |
Outcome results
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.
Time frame: Baseline and End of Treatment (Up to ~ 16 weeks)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FOSAMAX PLUS/ FOSAMAX PLUS D | Change From Baseline in Alkaline Phosphatase at End of Treatment | -16.36 mg/dL | Standard Deviation 37.58 |
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.
Time frame: Baseline and End of Treatment (Up to ~ 16 weeks)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FOSAMAX PLUS/ FOSAMAX PLUS D | Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment | 1.73 ng/mL | Standard Deviation 1.48 |
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.
Time frame: Baseline and End of Treatment (Up to ~ 16 weeks)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FOSAMAX PLUS/ FOSAMAX PLUS D | Change From Baseline in Serum Osteocalcin at End of Treatment | 0.69 ng/mL | Standard Deviation 0.32 |
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.
Time frame: Baseline and End of Treatment (Up to ~ 16 weeks)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FOSAMAX PLUS/ FOSAMAX PLUS D | Change From Baseline in Urine Deoxypyridinoline at End of Treatment | 1.03 nmol/mmol | Standard Deviation 0.83 |
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.
Time frame: Baseline and end of Treatment (Up to ~ 16 weeks)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FOSAMAX PLUS/ FOSAMAX PLUS D | Number of Participants With Improved, Unchanged, or Worsened Disease | Improved | 549 Participants |
| FOSAMAX PLUS/ FOSAMAX PLUS D | Number of Participants With Improved, Unchanged, or Worsened Disease | Unchanged | 239 Participants |
| FOSAMAX PLUS/ FOSAMAX PLUS D | Number of Participants With Improved, Unchanged, or Worsened Disease | Worsened | 1 Participants |
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.
Time frame: Up to ~ 16 weeks and 14 days after treatment discontinuation
Population: Safety evaluation was performed in participants who took at least one dose of study medication and completed \> 1 follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FOSAMAX PLUS/ FOSAMAX PLUS D | Number of Participants With Non-Serious AEs | 42 Participants |
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: * 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
Time frame: Up to ~ 16 weeks and 14 days after treatment discontinuation
Population: Safety evaluation was performed in participants who took at least one dose of study medication and completed \> 1 follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FOSAMAX PLUS/ FOSAMAX PLUS D | Number of Participants With Serious Adverse Events | 0 Participants |
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.
Time frame: Up to ~ 16 weeks and 14 days after treatment discontinuation
Population: Safety evaluation was performed in participants who took at least one dose of study medication and completed \> 1 follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FOSAMAX PLUS/ FOSAMAX PLUS D | Number of Participants With Unexpected Adverse Events | 2 Participants |