Back Pain, Osteoporosis, Postmenopausal, Spinal Fracture
Conditions
Brief summary
The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.
Interventions
DRUGteriparatide
20 ug/day, subcutaneous, 18 months
DRUGrisedronate
35 mg/once weekly, oral, 18 months
DRUGplacebo
once weekly, oral, 18 months
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women 45 years or older. No period for at least two years. * History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator). * Minimum of one moderate spinal bone fracture. * Beginning pain level of at least four on an eleven point scale. * Bone Mineral Density (BMD) must meet criteria * Able to read, understand, and administer self-questionnaires. * Be willing and able to use a pen-injector to deliver the medication.
Exclusion criteria
* Are at increased risk for osteosarcoma. * Have an active or suspected diseases that affects bone metabolism other than osteoporosis. * Participants that already know that they will require procedures to repair their spinal bone fractures. * Abnormal values of certain lab tests. * Anything that would make it difficult to determine if the back pain was due to the fracture. * Poor medical or psychiatric condition. * Alcohol or drug abuse within a year of the study start. * Certain malignant neoplasms in the 5 years prior to enrollment. * Active liver disease or clinical jaundice. * Significantly impaired renal function. * History of nephrolithiasis or urolithiasis within 2 years prior to enrollment. * Known contraindication or intolerance to risedronate and/or teriparatide therapy. * Treatment with oral strontium or certain therapeutic doses of fluoride.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint | 6 Months | 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint | 6 Months | 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint. |
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint | 12 Months | 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint. |
| Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300 | Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. |
| Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 | Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. |
| Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300 | Time to first occurrence of \>=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. |
| Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 | Time to first occurrence of \>= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. |
| Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire. | Baseline, 3 Months | Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). |
| Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire. | Baseline, 6 Months | Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). |
| Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire. | Baseline, 12 Months | Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). |
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint | 12 Months | 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint. |
| Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | Baseline, 12 Months | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. |
| Number of Participants With Adverse Events (Safety) During 12 Months | Baseline through 12 Months | Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section. |
| Number of Participants With Adverse Events (Safety) During 18 Months | Baseline through 18 Months | Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section. |
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint | 18 Months | 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint. |
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint | 18 Months | 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint. |
| Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months | Baseline through 18 Months | Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. |
| Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months | Baseline through 18 Months | Time to first occurrence of \>=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. |
| Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire. | Baseline, 18 Months | Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for. |
| Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | Baseline, 18 Months | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. |
| Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | Baseline, 6 Months | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, Spain, Sweden, United States
Participant flow
Pre-assignment details
712 participants were randomized: 361 to teriparatide; 351 to risedronate. 2 participants did not receive drug. Only randomized participants who received at least 1 dose of drug were analyzed. At 18 months, reason for discontinuation was corrected from sponsor decision to entry criteria not met (1) and protocol violation (1) for 2 participants.
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo | 360 |
| Risedronate Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo | 350 |
| Total | 710 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Months (All Treated Participants) | Adverse Event | 22 | 20 |
| 12 Months (All Treated Participants) | Death | 3 | 3 |
| 12 Months (All Treated Participants) | Entry Criteria Not Met | 10 | 10 |
| 12 Months (All Treated Participants) | Lack of Efficacy | 1 | 1 |
| 12 Months (All Treated Participants) | Lost to Follow-up | 1 | 5 |
| 12 Months (All Treated Participants) | Physician Decision | 4 | 5 |
| 12 Months (All Treated Participants) | Protocol Violation | 3 | 2 |
| 12 Months (All Treated Participants) | Sponsor Decision | 9 | 6 |
| 12 Months (All Treated Participants) | Withdrawal by Subject | 33 | 17 |
| 18 Months (All Treated Participants) | Adverse Event | 31 | 23 |
| 18 Months (All Treated Participants) | Death | 4 | 5 |
| 18 Months (All Treated Participants) | Entry Criteria Not Met | 11 | 10 |
| 18 Months (All Treated Participants) | Lack of Efficacy | 1 | 1 |
| 18 Months (All Treated Participants) | Lost to Follow-up | 3 | 7 |
| 18 Months (All Treated Participants) | Physician Decision | 4 | 7 |
| 18 Months (All Treated Participants) | Protocol Violation | 3 | 3 |
| 18 Months (All Treated Participants) | Sponsor Decision | 8 | 5 |
| 18 Months (All Treated Participants) | Withdrawal by Subject | 36 | 20 |
| 6 Months (All Treated Participants) | Adverse Event | 17 | 11 |
| 6 Months (All Treated Participants) | Death | 0 | 2 |
| 6 Months (All Treated Participants) | Entry Criteria Not Met | 10 | 8 |
| 6 Months (All Treated Participants) | Lack of Efficacy | 0 | 1 |
| 6 Months (All Treated Participants) | Lost to Follow-up | 0 | 4 |
| 6 Months (All Treated Participants) | Physician Decision | 1 | 3 |
| 6 Months (All Treated Participants) | Protocol Violation | 2 | 2 |
| 6 Months (All Treated Participants) | Sponsor Decision | 7 | 4 |
| 6 Months (All Treated Participants) | Withdrawal by Subject | 19 | 9 |
Baseline characteristics
| Characteristic | Teriparatide | Total | Risedronate |
|---|---|---|---|
| 24-Hour Average Back Pain Score | 5.34 units on a scale STANDARD_DEVIATION 1.86 | 5.37 units on a scale STANDARD_DEVIATION 1.85 | 5.40 units on a scale STANDARD_DEVIATION 1.85 |
| 24-Hour Worst Back Pain Score | 6.80 units on a scale STANDARD_DEVIATION 1.63 | 6.85 units on a scale STANDARD_DEVIATION 1.59 | 6.91 units on a scale STANDARD_DEVIATION 1.54 |
| Age Continuous | 70.54 years STANDARD_DEVIATION 8.8 | 71.04 years STANDARD_DEVIATION 8.48 | 71.55 years STANDARD_DEVIATION 8.12 |
| Body Mass Index | 26.30 kilograms/meters squared STANDARD_DEVIATION 5.01 | 26.33 kilograms/meters squared STANDARD_DEVIATION 4.96 | 26.36 kilograms/meters squared STANDARD_DEVIATION 4.91 |
| Duration of Back Pain | 550.33 days STANDARD_DEVIATION 918.18 | 550.58 days STANDARD_DEVIATION 842.78 | 550.88 days STANDARD_DEVIATION 750.47 |
| Height | 154.82 centimeters STANDARD_DEVIATION 7.41 | 154.23 centimeters STANDARD_DEVIATION 7.66 | 153.62 centimeters STANDARD_DEVIATION 7.86 |
| Number of Vertebral Fractures 1 Vertebral Fracture | 126 participants | 230 participants | 104 participants |
| Number of Vertebral Fractures >=2 Vertebral Fractures | 197 participants | 408 participants | 211 participants |
| Number of Vertebral Fractures Unknown or No Vertebral Fractures | 37 participants | 72 participants | 35 participants |
| Prior Osteoporosis Drug Use No | 93 participants | 185 participants | 92 participants |
| Prior Osteoporosis Drug Use Yes | 267 participants | 525 participants | 258 participants |
| Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) Score | 47.08 units on a scale STANDARD_DEVIATION 14.61 | 47.03 units on a scale STANDARD_DEVIATION 14.49 | 46.98 units on a scale STANDARD_DEVIATION 14.39 |
| Race/Ethnicity, Customized African Descent | 2 participants | 5 participants | 3 participants |
| Race/Ethnicity, Customized Caucasian | 285 participants | 571 participants | 286 participants |
| Race/Ethnicity, Customized East Asian | 3 participants | 3 participants | 0 participants |
| Race/Ethnicity, Customized Hispanic | 67 participants | 128 participants | 61 participants |
| Race/Ethnicity, Customized Native American | 3 participants | 3 participants | 0 participants |
| Region of Enrollment Argentina | 38 participants | 80 participants | 42 participants |
| Region of Enrollment Australia | 30 participants | 60 participants | 30 participants |
| Region of Enrollment Belgium | 7 participants | 13 participants | 6 participants |
| Region of Enrollment Brazil | 30 participants | 60 participants | 30 participants |
| Region of Enrollment Canada | 54 participants | 109 participants | 55 participants |
| Region of Enrollment France | 13 participants | 23 participants | 10 participants |
| Region of Enrollment Germany | 36 participants | 70 participants | 34 participants |
| Region of Enrollment Italy | 22 participants | 42 participants | 20 participants |
| Region of Enrollment Mexico | 23 participants | 46 participants | 23 participants |
| Region of Enrollment Puerto Rico | 12 participants | 22 participants | 10 participants |
| Region of Enrollment Spain | 32 participants | 64 participants | 32 participants |
| Region of Enrollment Sweden | 13 participants | 23 participants | 10 participants |
| Region of Enrollment United States | 50 participants | 98 participants | 48 participants |
| Roland-Morris Disability Questionnaire Score | 11.88 units on a scale STANDARD_DEVIATION 5.47 | 12.00 units on a scale STANDARD_DEVIATION 5.44 | 12.12 units on a scale STANDARD_DEVIATION 5.4 |
| Severity of Vertebral Fracture Moderate Severity (Grade 2) | 160 participants | 326 participants | 166 participants |
| Severity of Vertebral Fracture Severe (Grade 3) | 142 participants | 273 participants | 131 participants |
| Severity of Vertebral Fracture Unknown or Not Reported | 8 participants | 15 participants | 7 participants |
| Severity of Vertebral Fracture Zero or Mild Severity (Grade 0) | 50 participants | 96 participants | 46 participants |
| Sex: Female, Male Female | 360 Participants | 710 Participants | 350 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Spinal Deformity Index 0 | 29 units on a scale | 57 units on a scale | 28 units on a scale |
| Spinal Deformity Index 1 | 11 units on a scale | 27 units on a scale | 16 units on a scale |
| Spinal Deformity Index 2 | 76 units on a scale | 143 units on a scale | 67 units on a scale |
| Spinal Deformity Index >=3 | 236 units on a scale | 468 units on a scale | 232 units on a scale |
| Spinal Deformity Index Unknown or Not Reported | 8 units on a scale | 15 units on a scale | 7 units on a scale |
| Weight | 63.02 kilograms STANDARD_DEVIATION 12.7 | 62.65 kilograms STANDARD_DEVIATION 12.63 | 62.27 kilograms STANDARD_DEVIATION 12.58 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 277 / 360 | 273 / 350 |
| serious Total, serious adverse events | 55 / 360 | 66 / 350 |
Outcome results
Primary
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Time frame: 6 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint | Responder to Treatment | 206 participants |
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint | Non-Responder to Treatment | 142 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint | Responder to Treatment | 193 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint | Non-Responder to Treatment | 143 participants |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.p-value: 0.642Chi-square
Secondary
Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time frame: Baseline, 12 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | -5.74 units on a scale | Standard Error 1.23 |
| Risedronate | Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | -5.27 units on a scale | Standard Error 1.22 |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.p-value: 0.572ANCOVA
Secondary
Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time frame: Baseline, 12 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire. | -2.09 units on a scale | Standard Error 0.54 |
| Risedronate | Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire. | -2.12 units on a scale | Standard Error 0.53 |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.p-value: 0.932ANCOVA
Secondary
Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time frame: Baseline, 18 Months
Population: Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | -5.67 units on a scale | Standard Error 1.27 |
| Risedronate | Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | -5.17 units on a scale | Standard Error 1.26 |
p-value: 0.553ANCOVA
Secondary
Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.
Time frame: Baseline, 18 Months
Population: Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire. | -3.21 units on a scale | Standard Error 0.54 |
| Risedronate | Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire. | -3.19 units on a scale | Standard Error 0.53 |
p-value: 0.943ANCOVA
Secondary
Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time frame: Baseline, 3 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire. | -1.42 units on a scale | Standard Error 0.45 |
| Risedronate | Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire. | -1.41 units on a scale | Standard Error 0.45 |
Comparison: Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.p-value: 0.968ANCOVA
Secondary
Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time frame: Baseline, 6 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | -2.80 units on a scale | Standard Error 1.11 |
| Risedronate | Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | -2.63 units on a scale | Standard Error 1.1 |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.p-value: 0.814ANCOVA
Secondary
Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time frame: Baseline, 6 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire. | -1.58 units on a scale | Standard Error 0.48 |
| Risedronate | Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire. | -1.77 units on a scale | Standard Error 0.48 |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.p-value: 0.568ANCOVA
Secondary
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
Time frame: 12 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint | Responder to Treatment | 246 participants |
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint | Non-Responder to Treatment | 101 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint | Responder to Treatment | 238 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint | Non-Responder to Treatment | 98 participants |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.p-value: 0.986Chi-square
Secondary
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
Time frame: 18 Months
Population: Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint | Responder | 260 participants |
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint | Non-responder | 100 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint | Responder | 242 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint | Non-responder | 107 participants |
p-value: 0.399Chi-squared
Secondary
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Time frame: 6 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint | Responder to Treatment | 221 participants |
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint | Non-Responder to Treatment | 126 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint | Responder to Treatment | 211 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint | Non-Responder to Treatment | 125 participants |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.p-value: 0.809Chi-square
Secondary
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
Time frame: 12 Months
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint | Responder to Treatment | 233 participants |
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint | Non-Responder to Treatment | 115 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint | Responder to Treatment | 220 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint | Non-Responder to Treatment | 116 participants |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.p-value: 0.683Chi-square
Secondary
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
Time frame: 18 Months
Population: Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint | Responder | 248 participants |
| Teriparatide | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint | Non-Responder | 112 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint | Responder | 234 participants |
| Risedronate | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint | Non-Responder | 115 participants |
p-value: 0.6Chi-squared
Secondary
Number of Participants With Adverse Events (Safety) During 12 Months
Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Time frame: Baseline through 12 Months
Population: Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants With Adverse Events (Safety) During 12 Months | Serious Adverse Events | 39 participants |
| Teriparatide | Number of Participants With Adverse Events (Safety) During 12 Months | Adverse Events | 269 participants |
| Risedronate | Number of Participants With Adverse Events (Safety) During 12 Months | Serious Adverse Events | 50 participants |
| Risedronate | Number of Participants With Adverse Events (Safety) During 12 Months | Adverse Events | 266 participants |
Secondary
Number of Participants With Adverse Events (Safety) During 18 Months
Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Time frame: Baseline through 18 Months
Population: Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants With Adverse Events (Safety) During 18 Months | Serious Adverse Events | 55 participants |
| Teriparatide | Number of Participants With Adverse Events (Safety) During 18 Months | Adverse Events | 277 participants |
| Risedronate | Number of Participants With Adverse Events (Safety) During 18 Months | Adverse Events | 273 participants |
| Risedronate | Number of Participants With Adverse Events (Safety) During 18 Months | Serious Adverse Events | 66 participants |
Secondary
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time frame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 180 | 195 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 360 | 226 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 120 | 151 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 420 | 233 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 240 | 206 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 480 | 233 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 60 | 70 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 540 | 233 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 300 | 224 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 600 | 233 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 0 | 0 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 600 | 220 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 0 | 0 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 60 | 74 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 120 | 145 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 180 | 181 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 240 | 193 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 300 | 206 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 360 | 209 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 420 | 220 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 480 | 220 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | Day 540 | 220 participants |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 12-month endpoint.p-value: 0.71995% CI: [0.86, 1.25]Log Rank
Secondary
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time frame: Baseline through 18 Months
Population: Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months | 248 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months | 234 participants |
p-value: 0.45395% CI: [0.89, 1.28]Log Rank
Secondary
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time frame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 120 | 151 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 0 | 0 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 30 | 26 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 60 | 70 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 240 | 206 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 90 | 110 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 150 | 175 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 180 | 195 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 210 | 206 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 270 | 206 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 300 | 206 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 240 | 193 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 150 | 164 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 0 | 0 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 300 | 193 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 30 | 22 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 180 | 181 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 60 | 74 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 270 | 193 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 210 | 192 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 90 | 111 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | Day 120 | 145 participants |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 6-month endpoint.p-value: 0.74695% CI: [0.85, 1.26]Log Rank
Secondary
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Time to first occurrence of \>= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time frame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 180 | 212 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 360 | 238 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 120 | 175 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 420 | 246 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 240 | 221 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 480 | 246 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 60 | 91 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 540 | 246 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 300 | 234 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 600 | 246 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 0 | 0 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 600 | 238 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 0 | 0 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 60 | 86 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 120 | 162 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 180 | 200 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 240 | 211 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 300 | 220 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 360 | 226 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 420 | 238 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 480 | 238 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | Day 540 | 238 participants |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in average back pain at the 12-month endpoint.p-value: 0.78995% CI: [0.86, 1.23]Log Rank
Secondary
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
Time to first occurrence of \>=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time frame: Baseline through 18 Months
Population: Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months | 260 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months | 242 participants |
p-value: 0.35395% CI: [0.91, 1.3]Log Rank
Secondary
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Time to first occurrence of \>=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time frame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 30 | 40 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 180 | 212 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 90 | 136 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 210 | 221 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 0 | 0 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 240 | 221 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 60 | 91 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 270 | 221 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 150 | 199 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 300 | 221 participants |
| Teriparatide | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 120 | 175 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 300 | 211 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 0 | 0 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 30 | 33 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 60 | 86 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 90 | 130 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 120 | 162 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 150 | 178 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 180 | 200 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 210 | 210 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 240 | 211 participants |
| Risedronate | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | Day 270 | 211 participants |
Comparison: Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction for average back pain at the 6-month endpoint.p-value: 0.68195% CI: [0.86, 1.26]Log Rank