Osteoporosis
Conditions
Keywords
Low bone mass, Recent pertrochanteric hip fracture
Brief summary
This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.
Detailed description
The study has 3 periods: a screening phase, a double-blind, double-dummy treatment phase from the time of randomization to the 26 weeks visit, and an open-label treatment phase of approximately 12 month duration, where participants will continue treatment with the same study drug that they were randomized to.
Interventions
DRUGTeriparatide
Administered subcutaneously
DRUGRisedronate
Administered orally
DRUGPlacebo
Weekly: Administered orally Daily: Administered subcutaneously
DIETARY_SUPPLEMENTCalcium
Approximately 500 to 1000 mg/day administered orally throughout study.
DIETARY_SUPPLEMENTVitamin D
Approximately 800 International Units per day (IU/day) administered orally throughout study.
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
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region * Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men
Exclusion criteria
* Clinically significant abnormal laboratory values * History of unresolved skeletal diseases that affect bone metabolism * Polytrauma participants and participants with fractures at more than one site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lumbar Spine Areal Bone Mineral Density (BMD) | Baseline, Week 78 | Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Baseline, Week 26; Baseline, Week 52; Baseline, Week 78 | Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) . Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use. |
| Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26 | SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No). |
| Change in Lumbar Spine Areal Bone Mineral Density | Baseline, Week 26; Baseline, Week 52 | Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No). |
| Visual Analog Scale (VAS) | 6, 12, 18, and 26 Weeks | Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction. |
| Timed Up and Go Test | 6, 12, 18, and 26 Weeks | Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score. |
| Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | Baseline | Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous. |
Countries
Canada, Croatia, Czechia, Denmark, France, Germany, Greece, Italy, Mexico, Norway, Spain, United States
Participant flow
Pre-assignment details
Full Analysis Set (FAS) is defined as all randomized participants receiving at least one dose of study drug with at least one post-baseline efficacy measure.
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide 20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. | 86 |
| Risedronate 35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. | 85 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Open Label Phase (Week 26 to Week 78) | Adverse Event | 1 | 0 |
| Open Label Phase (Week 26 to Week 78) | Death | 0 | 2 |
| Open Label Phase (Week 26 to Week 78) | Lost to Follow-up | 1 | 1 |
| Open Label Phase (Week 26 to Week 78) | Physician Decision | 0 | 1 |
| Open Label Phase (Week 26 to Week 78) | Withdrawal by Subject | 1 | 2 |
| Treatment Phase (Week 0 to Week 26) | Adverse Event | 3 | 3 |
| Treatment Phase (Week 0 to Week 26) | Caregiver Decision | 1 | 2 |
| Treatment Phase (Week 0 to Week 26) | Death | 0 | 1 |
| Treatment Phase (Week 0 to Week 26) | Entry Criteria Not Met | 3 | 3 |
| Treatment Phase (Week 0 to Week 26) | Lost to Follow-up | 2 | 1 |
| Treatment Phase (Week 0 to Week 26) | No efficacy data | 20 | 25 |
| Treatment Phase (Week 0 to Week 26) | Not Treated | 5 | 3 |
| Treatment Phase (Week 0 to Week 26) | Physician Decision | 2 | 1 |
| Treatment Phase (Week 0 to Week 26) | Sponsor Decision | 1 | 1 |
| Treatment Phase (Week 0 to Week 26) | Withdrawal by Subject | 14 | 8 |
Baseline characteristics
| Characteristic | Total | Risedronate | Teriparatide |
|---|---|---|---|
| Age, Continuous | 76.8 years STANDARD_DEVIATION 7.71 | 76.4 years STANDARD_DEVIATION 7.47 | 77.2 years STANDARD_DEVIATION 7.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 171 Participants | 85 Participants | 86 Participants |
| Region of Enrollment Austria | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Canada | 2 participants | 2 participants | 0 participants |
| Region of Enrollment Czech Republic | 20 participants | 12 participants | 8 participants |
| Region of Enrollment Denmark | 22 participants | 9 participants | 13 participants |
| Region of Enrollment France | 13 participants | 8 participants | 5 participants |
| Region of Enrollment Germany | 3 participants | 1 participants | 2 participants |
| Region of Enrollment Greece | 7 participants | 4 participants | 3 participants |
| Region of Enrollment Ireland | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Italy | 26 participants | 10 participants | 16 participants |
| Region of Enrollment Mexico | 18 participants | 12 participants | 6 participants |
| Region of Enrollment Norway | 7 participants | 2 participants | 5 participants |
| Region of Enrollment Spain | 40 participants | 19 participants | 21 participants |
| Region of Enrollment Sweden | 5 participants | 2 participants | 3 participants |
| Region of Enrollment United Kingdom | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 5 participants | 4 participants | 1 participants |
| Sex: Female, Male Female | 132 Participants | 66 Participants | 66 Participants |
| Sex: Female, Male Male | 39 Participants | 19 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 53 / 106 | 47 / 110 |
| serious Total, serious adverse events | 21 / 106 | 27 / 110 |
Outcome results
Primary
Change in Lumbar Spine Areal Bone Mineral Density (BMD)
Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
Time frame: Baseline, Week 78
Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change in Lumbar Spine Areal Bone Mineral Density (BMD) | 0.094 gram per square centimeter (g/cm^2) | Standard Error 0.0075 |
| Risedronate | Change in Lumbar Spine Areal Bone Mineral Density (BMD) | 0.055 gram per square centimeter (g/cm^2) | Standard Error 0.0081 |
p-value: <0.000195% CI: [0.025, 0.055]Mixed Models Analysis
Secondary
Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire
SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).
Time frame: Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26
Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Week 6 | 7.37 units on a scale | Standard Error 1.065 |
| Teriparatide | Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Week 12 | 11.32 units on a scale | Standard Error 1.207 |
| Teriparatide | Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Week 18 | 14.37 units on a scale | Standard Error 1.256 |
| Teriparatide | Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Week 26 | 16.34 units on a scale | Standard Error 1.278 |
| Risedronate | Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Week 26 | 14.36 units on a scale | Standard Error 1.258 |
| Risedronate | Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Week 6 | 5.10 units on a scale | Standard Error 1.087 |
| Risedronate | Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Week 18 | 12.81 units on a scale | Standard Error 1.26 |
| Risedronate | Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire | Week 12 | 11.09 units on a scale | Standard Error 1.208 |
Secondary
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) . Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use.
Time frame: Baseline, Week 26; Baseline, Week 52; Baseline, Week 78
Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Total Hip 26 Weeks | -0.001 g/cm^2 | Standard Error 0.0042 |
| Teriparatide | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Total Hip 52 Weeks | 0.001 g/cm^2 | Standard Error 0.0042 |
| Teriparatide | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Total Hip 78 Weeks | 0.007 g/cm^2 | Standard Error 0.0042 |
| Teriparatide | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Femoral Neck 26 Weeks | 0.002 g/cm^2 | Standard Error 0.0044 |
| Teriparatide | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Femoral Neck 52 Weeks | -0.000 g/cm^2 | Standard Error 0.0044 |
| Teriparatide | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Femoral Neck 78 Weeks | 0.012 g/cm^2 | Standard Error 0.0044 |
| Risedronate | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Femoral Neck 52 Weeks | -0.006 g/cm^2 | Standard Error 0.0044 |
| Risedronate | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Total Hip 26 Weeks | -0.001 g/cm^2 | Standard Error 0.0042 |
| Risedronate | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Femoral Neck 26 Weeks | -0.009 g/cm^2 | Standard Error 0.0043 |
| Risedronate | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Total Hip 52 Weeks | -0.001 g/cm^2 | Standard Error 0.0042 |
| Risedronate | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Femoral Neck 78 Weeks | -0.007 g/cm^2 | Standard Error 0.0045 |
| Risedronate | Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb | Total Hip 78 Weeks | 0.005 g/cm^2 | Standard Error 0.0043 |
Secondary
Change in Lumbar Spine Areal Bone Mineral Density
Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
Time frame: Baseline, Week 26; Baseline, Week 52
Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Change in Lumbar Spine Areal Bone Mineral Density | Week 52 | 0.078 g/cm^2 | Standard Error 0.0074 |
| Teriparatide | Change in Lumbar Spine Areal Bone Mineral Density | Week 26 | 0.053 g/cm^2 | Standard Error 0.0074 |
| Risedronate | Change in Lumbar Spine Areal Bone Mineral Density | Week 26 | 0.032 g/cm^2 | Standard Error 0.0081 |
| Risedronate | Change in Lumbar Spine Areal Bone Mineral Density | Week 52 | 0.044 g/cm^2 | Standard Error 0.0081 |
Secondary
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.
Time frame: Baseline
Population: All randomized participants receiving at least one dose of study drug and having baseline Charnley's Pain Scale data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 0-No pain | 9.4 percentage of participants |
| Teriparatide | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 4- Pain severe on attempting to walk | 20.0 percentage of participants |
| Teriparatide | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 1- Pain slight or intermittent | 4.7 percentage of participants |
| Teriparatide | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 2- Pain occurs only after some activity | 23.5 percentage of participants |
| Teriparatide | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 3- Pain is tolerable | 36.5 percentage of participants |
| Teriparatide | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 5- Pain severe and spontaneous | 5.9 percentage of participants |
| Risedronate | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 4- Pain severe on attempting to walk | 15.3 percentage of participants |
| Risedronate | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 3- Pain is tolerable | 38.8 percentage of participants |
| Risedronate | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 2- Pain occurs only after some activity | 20.0 percentage of participants |
| Risedronate | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 0-No pain | 8.2 percentage of participants |
| Risedronate | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 5- Pain severe and spontaneous | 4.7 percentage of participants |
| Risedronate | Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale | 1- Pain slight or intermittent | 12.9 percentage of participants |
Secondary
Timed Up and Go Test
Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score.
Time frame: 6, 12, 18, and 26 Weeks
Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Timed Up and Go Test | Week 6 | 26.45 seconds (sec) | Standard Error 1.09 |
| Teriparatide | Timed Up and Go Test | Week 12 | 20.13 seconds (sec) | Standard Error 1.092 |
| Teriparatide | Timed Up and Go Test | Week 18 | 17.75 seconds (sec) | Standard Error 1.093 |
| Teriparatide | Timed Up and Go Test | Week 26 | 16.69 seconds (sec) | Standard Error 1.095 |
| Risedronate | Timed Up and Go Test | Week 26 | 19.91 seconds (sec) | Standard Error 1.088 |
| Risedronate | Timed Up and Go Test | Week 6 | 32.38 seconds (sec) | Standard Error 1.085 |
| Risedronate | Timed Up and Go Test | Week 18 | 21.14 seconds (sec) | Standard Error 1.087 |
| Risedronate | Timed Up and Go Test | Week 12 | 24.48 seconds (sec) | Standard Error 1.086 |
Secondary
Visual Analog Scale (VAS)
Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.
Time frame: 6, 12, 18, and 26 Weeks
Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Visual Analog Scale (VAS) | Week 6 | 16.44 millimeter (mm) | Standard Error 3.977 |
| Teriparatide | Visual Analog Scale (VAS) | Week 12 | 9.28 millimeter (mm) | Standard Error 4.048 |
| Teriparatide | Visual Analog Scale (VAS) | Week 18 | 6.90 millimeter (mm) | Standard Error 4.147 |
| Teriparatide | Visual Analog Scale (VAS) | Week 26 | 4.48 millimeter (mm) | Standard Error 4.128 |
| Risedronate | Visual Analog Scale (VAS) | Week 26 | 13.74 millimeter (mm) | Standard Error 4.505 |
| Risedronate | Visual Analog Scale (VAS) | Week 6 | 23.54 millimeter (mm) | Standard Error 4.443 |
| Risedronate | Visual Analog Scale (VAS) | Week 18 | 18.19 millimeter (mm) | Standard Error 4.508 |
| Risedronate | Visual Analog Scale (VAS) | Week 12 | 19.24 millimeter (mm) | Standard Error 4.452 |