Osteoporosis, Postmenopausal
Conditions
Keywords
osteoporosis, teriparatide, postmenopausal, MRI, finite element analysis
Brief summary
The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.
Detailed description
As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.
Interventions
DRUGteriparatide
20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* postmenopausal (after the change of life) women with osteoporosis * between the ages of 45-85 * have low bone mass as determined by a bone density test * have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites) * could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate
Exclusion criteria
* have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study * have a metal implant or have had a hip replacement in either hip which might affect results of study * have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton * currently have active or suspected diseases that affect the bone, other than osteoporosis * have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint | Baseline, 18 months | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
| Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
| Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
| Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | Baseline, 3, 6, 12, 18, 24 months | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
| Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint | Baseline, 18 months | Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
| Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint | Baseline, 18 months | Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint | Baseline, 24 months | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
| Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint | Baseline, 18 months | Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
| Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
| Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
| Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
| Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint | Baseline, 18, 24 months | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
| Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint | Baseline, 3, 6, 24 months | PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
| Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint | Baseline, 3, 6, 24 months | CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
| Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint | Baseline, 18 months | Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Participants who completed the 18 month main study had an option to continue treatment for an additional 6 months (Extension Phase).
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide 20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extension Phase (18 - 24 Months) | Adverse Event | 1 |
| Extension Phase (18 - 24 Months) | Lost to Follow-up | 1 |
| Extension Phase (18 - 24 Months) | Physician Decision | 2 |
| Extension Phase (18 - 24 Months) | Protocol Violation | 1 |
| Main Study (0 - 18 Months) | Adverse Event | 4 |
| Main Study (0 - 18 Months) | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Teriparatide |
|---|---|
| Age Continuous | 61.96 years STANDARD_DEVIATION 8.14 |
| Dominant Hand Left | 1 participants |
| Dominant Hand Right | 33 participants |
| Femoral Neck T-Score | -2.38 units on a scale STANDARD_DEVIATION 0.67 |
| Lumbar Spine T-Score | -2.91 units on a scale STANDARD_DEVIATION 1.04 |
| Prevalent Fractures Any non-vertebral fracture | 17 participants |
| Prevalent Fractures Any vertebral fracture | 4 participants |
| Prevalent Fractures None | 14 participants |
| Prior Bisphosphonate Use No | 13 participants |
| Prior Bisphosphonate Use Yes | 21 participants |
| Race/Ethnicity, Customized Caucasian | 31 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants |
| Race/Ethnicity, Customized West Asian | 1 participants |
| Region of Enrollment Canada | 6 participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 0 Participants |
| Total Hip T-Score | -1.80 units on a scale STANDARD_DEVIATION 0.81 |
| Years Postmenopausal | 16.97 years STANDARD_DEVIATION 12.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 35 |
| serious Total, serious adverse events | 5 / 35 |
Outcome results
Primary
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time frame: Baseline, 18 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint | 4.53 percent (%) change of ratio | Standard Error 4.89 |
p-value: 0.363Mixed Model Repeated Measurements
Secondary
Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint | 18 month percent change (n=28) | -2.068 % change of g/cm² | Standard Error 0.763 |
| Teriparatide | Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint | 24 month percent change (n=25) | -2.733 % change of g/cm² | Standard Error 0.864 |
p-value: 0.013ANOVA
p-value: 0.005ANOVA
Secondary
Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint | 18 month percent change (n=28) | 2.792 % change of g/cm² | Standard Error 0.998 |
| Teriparatide | Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint | 24 month percent change (n=25) | 2.762 % change of g/cm² | Standard Error 1.312 |
p-value: 0.011ANOVA
p-value: 0.049ANOVA
Secondary
Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint | 24 month percent change (n=25) | 8.702 % change of g/square centimeter (g/cm²) | Standard Error 0.939 |
| Teriparatide | Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint | 18 month percent change (n=28) | 7.215 % change of g/square centimeter (g/cm²) | Standard Error 1.166 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint | 18 month percent change (n=28) | -1.891 % change of g/cm² | Standard Error 1.122 |
| Teriparatide | Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint | 24 month percent change (n=25) | 0.776 % change of g/cm² | Standard Error 0.975 |
p-value: 0.106ANOVA
p-value: 0.436ANOVA
Secondary
Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint
Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint | 18 month percent change (n=28) | 0.292 % change of g/cm² | Standard Error 0.747 |
| Teriparatide | Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint | 24 month percent change (n=25) | 1.482 % change of g/cm² | Standard Error 0.836 |
p-value: 0.7ANOVA
p-value: 0.092ANOVA
Secondary
Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint
BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time frame: Baseline, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | 18 month percent change (n=25) | 0.36 % change of ratio | Standard Error 1.85 |
| Teriparatide | Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | 24 month percent change (n=21) | -3.14 % change of ratio | Standard Error 2.4 |
p-value: 0.847Mixed Model Repeated Measurements
p-value: 0.212Mixed Model Repeated Measurements
Secondary
Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint
Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time frame: Baseline, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | 18 month percent change (n=25) | -0.61 % change of millimeter (mm) | Standard Error 2.56 |
| Teriparatide | Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | 24 month percent change (n=21) | -0.22 % change of millimeter (mm) | Standard Error 2.59 |
p-value: 0.816Mixed Model Repeated Measurements
p-value: 0.934Mixed Model Repeated Measurements
Secondary
Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint
CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time frame: Baseline, 3, 6, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint | 3 month percent change (n=32) | 63.53 % change of nanogram/milliliter (ng/mL) | Standard Error 23.78 |
| Teriparatide | Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint | 6 month percent change (n=30) | 102.56 % change of nanogram/milliliter (ng/mL) | Standard Error 38.42 |
| Teriparatide | Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint | 24 month percent change (n=23) | 48.28 % change of nanogram/milliliter (ng/mL) | Standard Error 18.36 |
p-value: 0.012Mixed Model Repeated Measurements
p-value: 0.012Mixed Model Repeated Measurements
p-value: 0.016Mixed Model Repeated Measurements
Secondary
Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint
PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time frame: Baseline, 3, 6, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint | 3 month percent change (n=32) | 145.35 % change of microgram/Liter (µg/L) | Standard Error 23.36 |
| Teriparatide | Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint | 6 month percent change (n=30) | 238.04 % change of microgram/Liter (µg/L) | Standard Error 44.29 |
| Teriparatide | Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint | 24 month percent change (n=23) | 118.91 % change of microgram/Liter (µg/L) | Standard Error 22.72 |
p-value: <0.001Mixed Model Repeated Measurements
p-value: <0.001Mixed Model Repeated Measurements
p-value: <0.001Mixed Model Repeated Measurements
Secondary
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time frame: Baseline, 3, 6, 12, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | 3 month percent change (n=32) | -3.38 % change of ratio | Standard Error 3.46 |
| Teriparatide | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | 6 month percent change (n=30) | 0.43 % change of ratio | Standard Error 4.05 |
| Teriparatide | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | 12 month percent change (n=28) | 2.36 % change of ratio | Standard Error 4.56 |
| Teriparatide | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | 18 month percent change (n=25) | 4.53 % change of ratio | Standard Error 4.89 |
| Teriparatide | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | 24 month percent change (n=21) | 1.44 % change of ratio | Standard Error 6.88 |
p-value: 0.335Mixed Model Repeated Measurements
p-value: 0.916Mixed Model Repeated Measurements
p-value: 0.61Mixed Model Repeated Measurements
p-value: 0.363Mixed Model Repeated Measurements
p-value: 0.837Mixed Model Repeated Measurements
Secondary
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time frame: Baseline, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint | 1.44 % change of ratio | Standard Error 6.88 |
p-value: 0.837Mixed Model Repeated Measurements
Secondary
Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint
Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint | 2.54 % change of Newtons | Standard Error 1.18 |
p-value: 0.045ANOVA
Secondary
Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint
Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint | 17.43 % change of Newtons | Standard Error 2.57 |
p-value: <0.001ANOVA
Secondary
Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint
TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
Time frame: Baseline, 18, 24 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | 18 month percent change (n=25) | 3.36 % change of ratio | Standard Error 3.31 |
| Teriparatide | Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | 24 month percent change (n=21) | 8.46 % change of ratio | Standard Error 4.63 |
p-value: 0.324Mixed Model Repeated Measures
p-value: 0.089Mixed Model Repeated Measures
Secondary
Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint
Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint | 2.22 % change of mg/cm³ | Standard Error 0.88 |
p-value: 0.021ANOVA
Secondary
Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint
Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time frame: Baseline, 18 months
Population: Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint | 10.05 % change of mg/cm³ | Standard Error 1.55 |
p-value: <0.001ANOVA