Osteoporosis
Conditions
Brief summary
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
Interventions
DRUGTeriparatide
daily, subcutaneous
DRUGPlacebo
daily, subcutaneous
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
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Japanese patients diagnosed with osteoporosis * Aged 55 or older * Patients who are at high risk for fracture
Exclusion criteria
* History of metabolic bone disorders other than primary osteoporosis * History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. * Severe or chronically disabling conditions other than osteoporosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Baseline to 52 weeks | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) at Total Hip | Baseline to 52 Weeks | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. |
| Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Baseline to 52 Weeks | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Baseline to Weeks 4, 12, 24, and 52 | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Baseline to Weeks 4, 12, 24, 52 | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Baseline to Weeks 4, 12, 24, 52 | Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point. |
| Vertebral Fractures by Central X-ray Assessment | Baseline through 52 weeks | Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. |
| Fractures by Investigators Assessment | Baseline through 52 Weeks | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma. |
| Back Pain Severity | Baseline, Weeks 12, 24, 36, 52 | Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe). |
| Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. |
| Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Baseline to 52 Weeks | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. |
| Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. |
| Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point. |
| Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | Baseline through 104 Weeks | Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. |
| Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Baseline Through 104 Weeks | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma. |
| Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe). |
| Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. |
Countries
Japan
Participant flow
Pre-assignment details
Results from 4 patients aren't included in baseline and outcomes: 3 (2 placebo and 1 teriparatide) didn't receive study drug; 1 (placebo) had a significant good clinical practice issue of receiving study drug assigned to another patient.
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide 20 micrograms for 104 weeks | 136 |
| Placebo Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks | 67 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 104 Weeks, 28-Week OL Period | Adverse Event | 2 | 0 |
| 104 Weeks, 28-Week OL Period | Physician Decision | 0 | 1 |
| 104 Weeks, 28-Week OL Period | Withdrawal by Subject | 8 | 2 |
| 52-Week Double-Blind (DB) Period | Adverse Event | 6 | 2 |
| 52-Week Double-Blind (DB) Period | Death | 0 | 0 |
| 52-Week Double-Blind (DB) Period | Entry Criteria Exclusion | 0 | 1 |
| 52-Week Double-Blind (DB) Period | Lack of Efficacy | 1 | 2 |
| 52-Week Double-Blind (DB) Period | Lost to Follow-up | 0 | 0 |
| 52-Week Double-Blind (DB) Period | Physician Decision | 4 | 2 |
| 52-Week Double-Blind (DB) Period | Protocol Violation | 0 | 2 |
| 52-Week Double-Blind (DB) Period | Sponsor Decision | 0 | 0 |
| 52-Week Double-Blind (DB) Period | Withdrawal by Subject | 6 | 1 |
| 76 Weeks, 24-Week Open Label (OL) Period | Adverse Event | 3 | 1 |
| 76 Weeks, 24-Week Open Label (OL) Period | Lack of Efficacy | 0 | 1 |
| 76 Weeks, 24-Week Open Label (OL) Period | Physician Decision | 2 | 0 |
| 76 Weeks, 24-Week Open Label (OL) Period | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Teriparatide | Total | Placebo |
|---|---|---|---|
| Age Continuous | 69.2 years STANDARD_DEVIATION 6.3 | 69.6 years STANDARD_DEVIATION 6 | 70.4 years STANDARD_DEVIATION 5.4 |
| Alcohol Consumption No | 99 participants | 150 participants | 51 participants |
| Alcohol Consumption Yes | 37 participants | 53 participants | 16 participants |
| Body Mass Index | 21.58 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.03 | 21.80 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.15 | 22.24 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.34 |
| Bone Mineral Density (BMD) Total Spine | 0.6153 grams per square centimeter (g/cm^2) STANDARD_DEVIATION 0.0701 | 0.6143 grams per square centimeter (g/cm^2) STANDARD_DEVIATION 0.0726 | 0.6123 grams per square centimeter (g/cm^2) STANDARD_DEVIATION 0.078 |
| Height | 150.40 centimeters (cm) STANDARD_DEVIATION 5.97 | 150.36 centimeters (cm) STANDARD_DEVIATION 5.89 | 150.30 centimeters (cm) STANDARD_DEVIATION 5.74 |
| Number of Previous Vertebral Fractures 0 Fractures | 82 participants | 120 participants | 38 participants |
| Number of Previous Vertebral Fractures 1 Fracture | 35 participants | 51 participants | 16 participants |
| Number of Previous Vertebral Fractures 2 Fractures | 10 participants | 18 participants | 8 participants |
| Number of Previous Vertebral Fractures 3 Fractures | 3 participants | 6 participants | 3 participants |
| Number of Previous Vertebral Fractures 4 Fractures | 4 participants | 5 participants | 1 participants |
| Number of Previous Vertebral Fractures 5 or More Fractures | 2 participants | 3 participants | 1 participants |
| Previous Osteoporosis Drug Use No | 86 participants | 130 participants | 44 participants |
| Previous Osteoporosis Drug Use Yes | 50 participants | 73 participants | 23 participants |
| Region of Enrollment Japan | 136 participants | 203 participants | 67 participants |
| Sex: Female, Male Female | 127 Participants | 189 Participants | 62 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 5 Participants |
| Smoking History Current Smoker | 16 participants | 21 participants | 5 participants |
| Smoking History Non-Smoker | 114 participants | 167 participants | 53 participants |
| Smoking History Past Smoker | 6 participants | 15 participants | 9 participants |
| Weight | 48.74 kilograms (kg) STANDARD_DEVIATION 6.83 | 49.24 kilograms (kg) STANDARD_DEVIATION 7.29 | 50.25 kilograms (kg) STANDARD_DEVIATION 8.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 115 / 136 | 59 / 67 | 123 / 136 | 60 / 67 | 125 / 136 | 64 / 67 |
| serious Total, serious adverse events | 7 / 136 | 7 / 67 | 10 / 136 | 9 / 67 | 12 / 136 | 13 / 67 |
Outcome results
Primary
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Time frame: Baseline to 52 weeks
Population: Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Percent Change to Last Measurement Point | 9.82 percent change in BMD | Standard Deviation 5.36 |
| Placebo | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Percent Change to Last Measurement Point | 0.04 percent change in BMD | Standard Deviation 4.34 |
Comparison: Null hypothesis: there is no difference in the percent change in bone mineral density at lumbar spine (L2-L4) after 52-week treatment between the two treatment groups.p-value: <0.001t-test, 2 sided
Secondary
Back Pain Severity
Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).
Time frame: Baseline, Weeks 12, 24, 36, 52
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Back Pain Severity | Week 52: 2 - Mild | 32 participants |
| Teriparatide | Back Pain Severity | Baseline: 1 - None | 77 participants |
| Teriparatide | Back Pain Severity | Baseline: 2 - Mild | 47 participants |
| Teriparatide | Back Pain Severity | Baseline: 3 - Moderate | 12 participants |
| Teriparatide | Back Pain Severity | Baseline: 4 - Severe | 0 participants |
| Teriparatide | Back Pain Severity | Week 12: 1 - None | 79 participants |
| Teriparatide | Back Pain Severity | Week 12: 2 - Mild | 44 participants |
| Teriparatide | Back Pain Severity | Week 12: 3 - Moderate | 8 participants |
| Teriparatide | Back Pain Severity | Week 12: 4 - Severe | 0 participants |
| Teriparatide | Back Pain Severity | Week 24: 1 - None | 87 participants |
| Teriparatide | Back Pain Severity | Week 24: 2 - Mild | 34 participants |
| Teriparatide | Back Pain Severity | Week 24: 3 - Moderate | 6 participants |
| Teriparatide | Back Pain Severity | Week 24: 4 - Severe | 0 participants |
| Teriparatide | Back Pain Severity | Week 36: 1 - None | 82 participants |
| Teriparatide | Back Pain Severity | Week 36: 2 - Mild | 36 participants |
| Teriparatide | Back Pain Severity | Week 36: 4 - Severe | 0 participants |
| Teriparatide | Back Pain Severity | Week 52: 1 - None | 84 participants |
| Teriparatide | Back Pain Severity | Week 36: 3 - Moderate | 5 participants |
| Teriparatide | Back Pain Severity | Week 52: 3 - Moderate | 5 participants |
| Teriparatide | Back Pain Severity | Week 52: 4 - Severe | 0 participants |
| Teriparatide | Back Pain Severity | Last Measurement: 1 - None | 90 participants |
| Teriparatide | Back Pain Severity | Last Measurement: 2 - Mild | 36 participants |
| Teriparatide | Back Pain Severity | Last Measurement: 3 - Moderate | 5 participants |
| Teriparatide | Back Pain Severity | Last Measurement: 4 - Severe | 0 participants |
| Placebo | Back Pain Severity | Week 52: 2 - Mild | 12 participants |
| Placebo | Back Pain Severity | Last Measurement: 3 - Moderate | 5 participants |
| Placebo | Back Pain Severity | Week 24: 4 - Severe | 0 participants |
| Placebo | Back Pain Severity | Baseline: 1 - None | 36 participants |
| Placebo | Back Pain Severity | Last Measurement: 1 - None | 44 participants |
| Placebo | Back Pain Severity | Baseline: 2 - Mild | 26 participants |
| Placebo | Back Pain Severity | Week 36: 1 - None | 42 participants |
| Placebo | Back Pain Severity | Baseline: 3 - Moderate | 4 participants |
| Placebo | Back Pain Severity | Week 52: 3 - Moderate | 5 participants |
| Placebo | Back Pain Severity | Baseline: 4 - Severe | 1 participants |
| Placebo | Back Pain Severity | Week 36: 2 - Mild | 15 participants |
| Placebo | Back Pain Severity | Week 12: 1 - None | 41 participants |
| Placebo | Back Pain Severity | Week 36: 3 - Moderate | 4 participants |
| Placebo | Back Pain Severity | Week 12: 2 - Mild | 18 participants |
| Placebo | Back Pain Severity | Last Measurement: 4 - Severe | 1 participants |
| Placebo | Back Pain Severity | Week 12: 3 - Moderate | 5 participants |
| Placebo | Back Pain Severity | Week 36: 4 - Severe | 0 participants |
| Placebo | Back Pain Severity | Week 12: 4 - Severe | 0 participants |
| Placebo | Back Pain Severity | Week 52: 4 - Severe | 1 participants |
| Placebo | Back Pain Severity | Week 24: 1 - None | 42 participants |
| Placebo | Back Pain Severity | Week 52: 1 - None | 42 participants |
| Placebo | Back Pain Severity | Week 24: 2 - Mild | 15 participants |
| Placebo | Back Pain Severity | Last Measurement: 2 - Mild | 14 participants |
| Placebo | Back Pain Severity | Week 24: 3 - Moderate | 4 participants |
Secondary
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).
Time frame: Baseline, 76 Weeks, 104 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 76: 1- None | 78 participants |
| Teriparatide | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 76: 2- Mild | 31 participants |
| Teriparatide | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 76: 3- Moderate | 4 participants |
| Teriparatide | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 76: 4- Severe | 0 participants |
| Teriparatide | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 104: 1- None | 66 participants |
| Teriparatide | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 104: 2- Mild | 23 participants |
| Teriparatide | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 104: 3- Moderate | 3 participants |
| Teriparatide | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 104: 4- Severe | 0 participants |
| Placebo | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 104: 4- Severe | 0 participants |
| Placebo | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 76: 1- None | 38 participants |
| Placebo | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 104: 1- None | 32 participants |
| Placebo | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 76: 2- Mild | 13 participants |
| Placebo | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 104: 3- Moderate | 2 participants |
| Placebo | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 76: 3- Moderate | 4 participants |
| Placebo | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 104: 2- Mild | 13 participants |
| Placebo | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Week 76: 4- Severe | 0 participants |
Secondary
Fractures by Investigators Assessment
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma.
Time frame: Baseline through 52 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Fractures by Investigators Assessment | Vertebral Fracture - Fragility | 0 number of fractures |
| Teriparatide | Fractures by Investigators Assessment | Vertebral Fracture - Traumatic | 0 number of fractures |
| Teriparatide | Fractures by Investigators Assessment | Non-Vertebra Fracture - Fragility | 1 number of fractures |
| Teriparatide | Fractures by Investigators Assessment | Non-Vertebra Fracture - Traumatic | 2 number of fractures |
| Placebo | Fractures by Investigators Assessment | Non-Vertebra Fracture - Traumatic | 3 number of fractures |
| Placebo | Fractures by Investigators Assessment | Vertebral Fracture - Fragility | 1 number of fractures |
| Placebo | Fractures by Investigators Assessment | Non-Vertebra Fracture - Fragility | 1 number of fractures |
| Placebo | Fractures by Investigators Assessment | Vertebral Fracture - Traumatic | 0 number of fractures |
Secondary
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma.
Time frame: Baseline Through 104 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Vertebral Fracture - Fragility - 104 Weeks | 0 number of fractures |
| Teriparatide | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Non-Vertebra Fracture - Fragility - 104 Weeks | 1 number of fractures |
| Teriparatide | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Non-Vertebra Fracture - Traumatic - 104 Weeks | 3 number of fractures |
| Teriparatide | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Vertebral Fracture - Traumatic - 104 Weeks | 0 number of fractures |
| Placebo | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Non-Vertebra Fracture - Traumatic - 104 Weeks | 4 number of fractures |
| Placebo | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Vertebral Fracture - Fragility - 104 Weeks | 1 number of fractures |
| Placebo | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Vertebral Fracture - Traumatic - 104 Weeks | 0 number of fractures |
| Placebo | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Non-Vertebra Fracture - Fragility - 104 Weeks | 1 number of fractures |
Secondary
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Time frame: Baseline to Weeks 4, 12, 24, 52
Population: Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Week 12 (n=131, n=62) | 3.23 percent change in BAP | Standard Deviation 49.05 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Week 52 (n=120, n=59) | -17.69 percent change in BAP | Standard Deviation 58.12 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Week 24 (n=127, n=60) | -4.60 percent change in BAP | Standard Deviation 43.44 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Last Measurement (n=136, n=66) | -17.32 percent change in BAP | Standard Deviation 56.06 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Week 4 (n=135, n=66) | 3.74 percent change in BAP | Standard Deviation 37.86 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Last Measurement (n=136, n=66) | -28.34 percent change in BAP | Standard Deviation 46.96 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Week 4 (n=135, n=66) | -9.63 percent change in BAP | Standard Deviation 33.62 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Week 12 (n=131, n=62) | -16.97 percent change in BAP | Standard Deviation 40.54 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Week 24 (n=127, n=60) | -28.46 percent change in BAP | Standard Deviation 23.81 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent Change to Week 52 (n=120, n=59) | -32.24 percent change in BAP | Standard Deviation 46.95 |
Comparison: Null hypothesis: there is no difference in the percent change in BAP after 4-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups.p-value: 0.06Wicoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups.p-value: 0.13Wilcoxon's Rank Sum Test
Secondary
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Time frame: Baseline, 76 Weeks, 104 Weeks
Population: Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=113, n=55 | 17.49 percent change in BAP | Standard Deviation 66.4 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=92, n=47 | -1.52 percent change in BAP | Standard Deviation 54.38 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=113, n=55 | 15.71 percent change in BAP | Standard Deviation 64.96 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=92, n=47 | 16.45 percent change in BAP | Standard Deviation 71.72 |
Secondary
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Time frame: Baseline to Weeks 4, 12, 24, and 52
Population: Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Week 12 (n=131, n=64) | 89.58 percent change in PINP | Standard Deviation 66.58 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Week 52 (n=121, n=60) | 116.11 percent change in PINP | Standard Deviation 139.72 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Week 24 (n=127, n=61) | 114.12 percent change in PINP | Standard Deviation 112.04 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Last Measurement (n=136,n=66) | 111.74 percent change in PINP | Standard Deviation 134.38 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Week 4 (n=136, n=66) | 90.67 percent change in PINP | Standard Deviation 49.85 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Last Measurement (n=136,n=66) | -13.82 percent change in PINP | Standard Deviation 28.42 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Week 4 (n=136, n=66) | -9.58 percent change in PINP | Standard Deviation 14.39 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Week 12 (n=131, n=64) | -16.89 percent change in PINP | Standard Deviation 17.35 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Week 24 (n=127, n=61) | -19.10 percent change in PINP | Standard Deviation 29.17 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent Change to Week 52 (n=121, n=60) | -14.18 percent change in PINP | Standard Deviation 29.02 |
Comparison: Null hypothesis: there is no difference in the percent change in PINP after 4-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Secondary
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Time frame: Baseline, 76 Weeks, 104 Weeks
Population: Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change to Week 76; n=113, n=55 | 115.45 percent change in PINP | Standard Deviation 174.07 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change to Week 104; n=92, n=47 | 74.71 percent change in PINP | Standard Deviation 112.48 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change to Week 76; n=113, n=55 | 97.28 percent change in PINP | Standard Deviation 131.64 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change to Week 104; n=92, n=47 | 134.89 percent change in PINP | Standard Deviation 180.76 |
Secondary
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
Time frame: Baseline to Weeks 4, 12, 24, 52
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Week 12 (n=121, n=61) | 46.52 percent change in CTX | Standard Deviation 69.52 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Week 52 (n=113, n=58) | 84.81 percent change in CTX | Standard Deviation 124.23 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Week 24 (n=119, n=59) | 82.27 percent change in CTX | Standard Deviation 110.54 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Last Measurement (n=126, n=65) | 79.41 percent change in CTX | Standard Deviation 119.61 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Week 4 (n=124, n=63) | 2.78 percent change in CTX | Standard Deviation 40.73 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Last Measurement (n=126, n=65) | 11.64 percent change in CTX | Standard Deviation 38.61 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Week 4 (n=124, n=63) | -2.05 percent change in CTX | Standard Deviation 28.17 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Week 12 (n=121, n=61) | -3.56 percent change in CTX | Standard Deviation 27.9 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Week 24 (n=119, n=59) | 4.39 percent change in CTX | Standard Deviation 37.97 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent Change to Week 52 (n=113, n=58) | 13.50 percent change in CTX | Standard Deviation 39.47 |
Comparison: Null hypothesis: there is no difference in the percent change in CTX after 4-week treatment between the two treatment groups.p-value: 0.976Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Comparison: Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups.p-value: <0.001Wilcoxon's Rank Sum Test
Secondary
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
Time frame: Baseline, 76 Weeks, 104 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=104, n=53 | 85.85 percent change in CTX | Standard Deviation 137.13 |
| Teriparatide | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=85, n=45 | 54.39 percent change in CTX | Standard Deviation 111.97 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=104, n=53 | 86.98 percent change in CTX | Standard Deviation 132.81 |
| Placebo | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=85, n=45 | 72.84 percent change in CTX | Standard Deviation 100.91 |
Secondary
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Time frame: Baseline, 76 Weeks, 104 Weeks
Population: Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=113, n=55 | 11.93 percent change in BMD | Standard Deviation 5.79 |
| Teriparatide | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=92, n=47 | 13.42 percent change in BMD | Standard Deviation 6.12 |
| Placebo | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=113, n=55 | 6.39 percent change in BMD | Standard Deviation 4.74 |
| Placebo | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=92, n=47 | 9.11 percent change in BMD | Standard Deviation 5.14 |
Secondary
Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Time frame: Baseline to 52 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Percent Change to Last Measurement Point | 2.24 percent change in BMD | Standard Deviation 6.01 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Percent Change to Last Measurement Point | 0.46 percent change in BMD | Standard Deviation 3.89 |
Secondary
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Time frame: Baseline, 76 Weeks, 104 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=112, n=54 | 2.68 percent change in BMD | Standard Deviation 4.45 |
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=91, n=46 | 3.26 percent change in BMD | Standard Deviation 4.25 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=112, n=54 | 1.17 percent change in BMD | Standard Deviation 4.81 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=91, n=46 | 2.19 percent change in BMD | Standard Deviation 4.81 |
Secondary
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Time frame: Baseline to 52 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Percent Change to Last Measurement Point | 10.23 percent change in BMD | Standard Deviation 5.74 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Percent Change to Last Measurement Point | 0.11 percent change in BMD | Standard Deviation 4.42 |
Secondary
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Time frame: Baseline, 76 Weeks, 104 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=113, n=55 | 12.24 percent change in BMD | Standard Deviation 5.86 |
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=92, n=47 | 14.01 percent change in BMD | Standard Deviation 6.41 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=113, n=55 | 6.63 percent change in BMD | Standard Deviation 4.69 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=92, n=47 | 9.46 percent change in BMD | Standard Deviation 5.35 |
Secondary
Percent Change in Bone Mineral Density (BMD) at Total Hip
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Time frame: Baseline to 52 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Total Hip | Percent Change to Last Measurement Point | 2.66 percent change in BMD | Standard Deviation 4.22 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Total Hip | Percent Change to Last Measurement Point | -0.22 percent change in BMD | Standard Deviation 3.38 |
Secondary
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Time frame: Baseline, 76 Weeks, 104 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=112, n=54 | 3.02 percent change in BMD | Standard Deviation 3.79 |
| Teriparatide | Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=91, n=46 | 3.67 percent change in BMD | Standard Deviation 3.98 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 76; n=112, n=54 | 1.64 percent change in BMD | Standard Deviation 4.63 |
| Placebo | Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Percent Change to Week 104; n=91, n=46 | 2.46 percent change in BMD | Standard Deviation 3.54 |
Secondary
Vertebral Fractures by Central X-ray Assessment
Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Time frame: Baseline through 52 weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Vertebral Fractures by Central X-ray Assessment | New Fractures (n=5, n=4) | 7 number of fractures |
| Teriparatide | Vertebral Fractures by Central X-ray Assessment | Worsening Fractures (n=2, n=0) | 3 number of fractures |
| Placebo | Vertebral Fractures by Central X-ray Assessment | New Fractures (n=5, n=4) | 5 number of fractures |
| Placebo | Vertebral Fractures by Central X-ray Assessment | Worsening Fractures (n=2, n=0) | 0 number of fractures |
Secondary
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Time frame: Baseline through 104 Weeks
Population: Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. The n's are the number of participants with fractures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | New Fractures at 104 Weeks (n=5, n=6) | 7 number of fractures |
| Teriparatide | Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | Worsening Fractures at 104 Weeks (n=2, n=2) | 3 number of fractures |
| Placebo | Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | New Fractures at 104 Weeks (n=5, n=6) | 7 number of fractures |
| Placebo | Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | Worsening Fractures at 104 Weeks (n=2, n=2) | 3 number of fractures |