Osteoporosis
Conditions
Keywords
Pharmacological therapy
Brief summary
The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.
Detailed description
This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets 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.
Interventions
Sodium risedronate tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Osteoporosis patients who meet all the following criteria: 1. Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets) 2. Male and postmenopausal female patients aged 50 years or older 3. Ambulatory outpatients
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | From baseline up to Month 36 | The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Percentage of Participants With Femur Fractures | From baseline up to Month 36 | The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36. |
| Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. |
| Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. |
| Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. |
| Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. |
| Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | — |
| Cumulative Percentage of Participants With Non-Vertebral Body Fractures | From baseline up to Month 36 | The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36. |
| Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | — |
| Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | — |
| Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | — |
| Change From Baseline in Height at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | — |
| Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36) | Final assessment (up to Month 36) | — |
| Number of Participants Who Had One or More Adverse Drug Reactions | Up to Month 36 | Adverse drug reaction refers to adverse events related to the administered drug. |
| Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) | — |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 148 investigative sites in Japan, from 13 May 2013 to 30 April 2018.
Pre-assignment details
Participants with a historical diagnosis of osteoporosis were enrolled. Participants received interventions as part of routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Sodium Risedronate 75 mg 75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care. | 542 |
| Total | 542 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 7 |
| Overall Study | Protocol Deviation | 30 |
Baseline characteristics
| Characteristic | Sodium Risedronate 75 mg | — |
|---|---|---|
| Age, Continuous | 75.9 Years STANDARD_DEVIATION 8 | — |
| Back Pain Had Back Pain | 346 Participants | — |
| Back Pain Had No Back Pain | 97 Participants | — |
| Back Pain Unknown | 99 Participants | — |
| BMI | 22.81 Kg/meters (m)^2 STANDARD_DEVIATION 4.81 | — |
| Concurrent Medication Had Concurrent Medication | 452 Participants | — |
| Concurrent Medication Had No Concurrent Medication | 90 Participants | — |
| Duration of Diagnosis of Osteoporosis | 1.5 Years STANDARD_DEVIATION 2.8 | — |
| Fracture Risk Factor: Alcohol Classification Drank <3 Units Daily | 356 Participants | — |
| Fracture Risk Factor: Alcohol Classification Drank >= 3 Units Daily | 27 Participants | — |
| Fracture Risk Factor: Alcohol Classification Unknown | 159 Participants | — |
| Fracture Risk Factor: History of Steroid Use, Excluding Steroids for External Use Had History of Steroid Use | 35 Participants | — |
| Fracture Risk Factor: History of Steroid Use, Excluding Steroids for External Use Had No History of Steroid Use | 477 Participants | — |
| Fracture Risk Factor: History of Steroid Use, Excluding Steroids for External Use Unknown | 30 Participants | — |
| Fracture Risk Factor: Medical History of Fracture Had Medical History | 305 Participants | — |
| Fracture Risk Factor: Medical History of Fracture Had No Medical History | 212 Participants | — |
| Fracture Risk Factor: Medical History of Fracture Unknown | 25 Participants | — |
| Fracture Risk Factor: Parental History of Femur Fracture Had Family History of Femur Fracture | 5 Participants | — |
| Fracture Risk Factor: Parental History of Femur Fracture Had No Family History of Femur Fracture | 243 Participants | — |
| Fracture Risk Factor: Parental History of Femur Fracture Unknown | 294 Participants | — |
| Fracture Risk Factor: Smoking Classification Current Smoker | 22 Participants | — |
| Fracture Risk Factor: Smoking Classification Ex-Smoker | 21 Participants | — |
| Fracture Risk Factor: Smoking Classification Never Smoked | 324 Participants | — |
| Fracture Risk Factor: Smoking Classification Unknown | 175 Participants | — |
| Height | 148.65 Centimeters (cm) STANDARD_DEVIATION 7.88 | — |
| Medical Complications Had Medical Complications | 453 Participants | — |
| Medical Complications Had No Medical Complications | 89 Participants | — |
| Medical History, Excluding History of Fracture Had Medical History | 111 Participants | — |
| Medical History, Excluding History of Fracture Had No Medical History | 397 Participants | — |
| Medical History, Excluding History of Fracture Unknown | 34 Participants | — |
| Osteoporosis Class Primary Osteoporosis | 481 Participants | — |
| Osteoporosis Class Secondary Osteoporosis | 28 Participants | — |
| Osteoporosis Class Unknown | 33 Participants | — |
| Other Concurrent Therapy Had No Other Concurrent Therapy | 378 Participants | — |
| Other Concurrent Therapy Had Other Concurrent Therapy | 164 Participants | — |
| Physical Therapy Had No Physical Therapy | 364 Participants | — |
| Physical Therapy Had Physical Therapy | 178 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 457 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 32 Participants | — |
| Predisposition to Hypersensitivity Unknown | 53 Participants | — |
| Previous Medication for Osteoporosis Had No Previous Medication for Osteoporosis | 341 Participants | — |
| Previous Medication for Osteoporosis Had Previous Medication for Osteoporosis | 201 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 542 Participants | — |
| Sex: Female, Male Female | 479 Participants | — |
| Sex: Female, Male Male | 63 Participants | — |
| Weight | 50.37 Kilograms (kg) STANDARD_DEVIATION 11.79 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 542 |
| other Total, other adverse events | 7 / 542 |
| serious Total, serious adverse events | 4 / 542 |
Outcome results
Primary
Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Time frame: From baseline up to Month 36
Population: Vertebral fractures assessment population; The vertebral fractures assessment population was defined as participants who completed the survey and had evaluable vertebral fractures data at baseline and post-baseline time points. Number analyzed is the number of participants who were evaluable at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | Month 6 | 5.43 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | Month 12 | 7.35 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | Month 18 | 7.80 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | Month 24 | 8.82 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | Month 30 | 9.97 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | Month 36 | 12.58 Percentage of Participants |
Secondary
Change From Baseline in Height at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Change From Baseline in Height at Final Assessment (up to Month 36) | -0.82 Centimeter | Standard Deviation 1.35 |
Secondary
Cumulative Percentage of Participants With Femur Fractures
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Time frame: From baseline up to Month 36
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Femur Fractures | Month 6 | 0.19 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Femur Fractures | Month 12 | 0.46 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Femur Fractures | Month 18 | 0.78 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Femur Fractures | Month 24 | 1.14 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Femur Fractures | Month 30 | 1.14 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Femur Fractures | Month 36 | 1.58 Percentage of Participants |
Secondary
Cumulative Percentage of Participants With Non-Vertebral Body Fractures
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Time frame: From baseline up to Month 36
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Non-Vertebral Body Fractures | Month 6 | 1.72 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Non-Vertebral Body Fractures | Month 12 | 2.78 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Non-Vertebral Body Fractures | Month 18 | 3.40 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Non-Vertebral Body Fractures | Month 24 | 4.11 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Non-Vertebral Body Fractures | Month 30 | 6.15 Percentage of Participants |
| Sodium Risedronate 75 mg | Cumulative Percentage of Participants With Non-Vertebral Body Fractures | Month 36 | 6.59 Percentage of Participants |
Secondary
Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
Time frame: Final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sodium Risedronate 75 mg | Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36) | 116 Participants |
Secondary
Number of Participants Who Had One or More Adverse Drug Reactions
Adverse drug reaction refers to adverse events related to the administered drug.
Time frame: Up to Month 36
Population: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sodium Risedronate 75 mg | Number of Participants Who Had One or More Adverse Drug Reactions | 57 Participants |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were 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 (up to Month 36) | -20.023 Percent Change | Standard Deviation 23.16 |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were 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 (up to Month 36) | -40.838 Percent Change | Standard Deviation 40.776 |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were 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 (up to Month 36) | -15.539 Percent Change | Standard Deviation 130.961 |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were 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 (up to Month 36) | -15.756 Percent Change | Standard Deviation 26.386 |
Secondary
Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were 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 (up to Month 36) | -25.285 Percent Change | Standard Deviation 62.112 |
Secondary
Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
BMD was measured by dual-energy X-ray absorptiometry.
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36) | 1.067 Percent Change | Standard Deviation 6.757 |
Secondary
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
BMD was measured by dual-energy X-ray absorptiometry.
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were 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 (up to Month 36) | 6.848 Percent Change | Standard Deviation 8.971 |
Secondary
Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
BMD was measured by dual-energy X-ray absorptiometry.
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36) | 3.498 Percent Change | Standard Deviation 10.608 |
Secondary
Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
BMD was measured by dual-energy X-ray absorptiometry.
Time frame: Baseline and final assessment (up to Month 36)
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Risedronate 75 mg | Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) | 1.496 Percent Change | Standard Deviation 6.841 |