Osteoporosis
Conditions
Keywords
Pharmacological therapy
Brief summary
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine the status of treatment compliance - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen
Detailed description
This surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) as well as to evaluate the status of treatment compliance in osteoporosis patients in daily medical practice. The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. For at least 30 minutes after administration, patients should avoid lying in a supine position and should avoid taking food, drink (except for water) or other oral drugs. For more details, see the Precautions related to dosage and administration section of the package insert.
Interventions
Sodium risedronate tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Osteoporosis patients
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to Month 12 | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline. |
| Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline. |
| Percent Change From Baseline in Radius BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline. |
| Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. |
| Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Baseline and final assessment (up to Month 12) | Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule. |
| Change From Baseline in Height | Baseline and final assessment (up to Month 12) | — |
| Number of Participants Who Had Lumbar Backache at Final Assessment | Final assessment (Month 12) | — |
| Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 606 investigative sites in Japan from 27-May 2013 to 30-April 2016 .
Pre-assignment details
Participants with a historical diagnosis of osteoporosis were enrolled to receive sodium risedronate 75 milligram (mg) for up to 12 months as per routine medical practice.
Participants by arm
| Arm | Count |
|---|---|
| Sodium Risedronate 75 mg Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months. | 3,058 |
| Total | 3,058 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case report forms uncollected | 99 |
| Overall Study | Protocol Violation | 147 |
Baseline characteristics
| Characteristic | Sodium Risedronate 75 mg |
|---|---|
| Age, Customized < 65 years | 373 Participants |
| Age, Customized ≥ 65 years | 2678 Participants |
| Age, Customized Unknown | 7 Participants |
| BMI < 18.5kg/m^2 | 162 Participants |
| BMI ≥ 18.5kg/m^2 < 25.0kg/m^2 | 1108 Participants |
| BMI ≥ 25.0kg/m^2 | 291 Participants |
| BMI Unknown | 1497 Participants |
| Concomitant Medication Had Concomitant Medication | 2512 Participants |
| Concomitant Medication Had No Concomitant Medication | 546 Participants |
| Medical Complications Had No Presence of Medical Complications | 409 Participants |
| Medical Complications Had Presence of Medical Complications | 2649 Participants |
| Medical History（not Inclusive of a History of Fractures） Had Medical History | 587 Participants |
| Medical History（not Inclusive of a History of Fractures） Had No Medical History | 2264 Participants |
| Medical History（not Inclusive of a History of Fractures） Unknown | 207 Participants |
| Osteoporosis Class Primary Osteoporosis | 2696 Participants |
| Osteoporosis Class Secondary Osteoporosis | 232 Participants |
| Osteoporosis Class Unknown | 130 Participants |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 2658 Participants |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 151 Participants |
| Predisposition to Hypersensitivity Unknown | 249 Participants |
| Pregnancy Status Not pregnant | 2329 Participants |
| Pregnancy Status Pregnant | 0 Participants |
| Pregnancy Status Unknown | 488 Participants |
| Pretreatment Osteoporosis Drug Had No Treatment Drug | 1909 Participants |
| Pretreatment Osteoporosis Drug Had Treatment Drug | 1149 Participants |
| Region of Enrollment Japan | 3058 Participants |
| Sex: Female, Male Female | 2817 Participants |
| Sex: Female, Male Male | 241 Participants |
| Weight < 50.0 kg | 1050 Participants |
| Weight ≥ 50.0 kg | 953 Participants |
| Weight Unknown | 1055 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 71 / 3,058 |
| serious Total, serious adverse events | 15 / 3,058 |
Outcome results
Primary
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment.
Time frame: Up to Month 12
Population: Safety Analysis Set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sodium Risedronate 75 mg | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 231 Participants |
Secondary
Change From Baseline in Height
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Change From Baseline in Height | -0.37 Centimeter | Standard Deviation 1.1 |
Secondary
Number of Participants Who Had Lumbar Backache at Final Assessment
Time frame: Final assessment (Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sodium Risedronate 75 mg | Number of Participants Who Had Lumbar Backache at Final Assessment | 663 Participants |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | -19.449 Percent change | Standard Deviation 28.058 |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | -46.302 Percent change | Standard Deviation 30.482 |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | -32.016 Percent change | Standard Deviation 30.219 |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | -14.024 Percent change | Standard Deviation 27.863 |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | -22.010 Percent change | Standard Deviation 60.634 |
Secondary
Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment
BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | 1.008 Percent change | Standard Deviation 5.473 |
Secondary
Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment
BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | 1.745 Percent change | Standard Deviation 5.18 |
Secondary
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment
BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | 4.700 Percent change | Standard Deviation 12.118 |
Secondary
Percent Change From Baseline in Radius BMD at Final Assessment
BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline.
Time frame: Baseline and final assessment (up to Month 12)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Radius BMD at Final Assessment | 1.173 Percent change | Standard Deviation 6.909 |