Postmenopausal Osteoporosis
Conditions
Keywords
Postmenopausal Osteoporosis
Brief summary
The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.
Interventions
DRUGRomozosumab
Administered by subcutaneous injection once a month.
DRUGTeriparatide
Administered by subcutaneous injection once a day.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women, aged ≥ 55 to ≤ 90. * Received oral bisphosphonate therapy for at least 3 years immediately prior to screening * BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck * History of nonvertebral fracture after age 50, or vertebral fracture.
Exclusion criteria
* Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids: * History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome. * Vitamin D insufficiency, defined as 25 (OH) vitamin D levels \< 20 ng/mL, as determined by the central laboratory. * Current hyper- or hypocalcemia * Current, uncontrolled hyper- or hypothyroidism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | Baseline, month 6 and month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Hip BMD at Month 12 | Baseline and month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). |
| Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | Baseline and month 6 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. |
| Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | Baseline and month 12 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. |
| Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 | Baseline and month 6 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. |
| Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 | Baseline and month 12 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. |
| Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 | Baseline and month 6 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. |
| Percent Change From Baseline in Total Hip BMD at Month 6 | Baseline and month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). |
| Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 | Baseline and month 6 | Total hip integral BMC was measured using quantitative computed tomography (QCT). |
| Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12 | Baseline and month 12 | Total hip integral BMC was measured using quantitative computed tomography (QCT). |
| Percent Change From Baseline in Femoral Neck BMD at Month 6 | Baseline and month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). |
| Percent Change From Baseline in Femoral Neck BMD at Month 12 | Baseline and month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). |
| Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Baseline and month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). |
| Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Baseline and month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). |
| Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 | Baseline and month 12 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. |
Countries
Argentina, Belgium, Canada, Colombia, Czechia, Denmark, Hungary, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 46 sites in North America, Latin America, and Europe. Participants were enrolled from 31 January 2013 to 29 April 2014.
Pre-assignment details
A total of 777 subjects were screened for participation; 341 (43.9%) were excluded prior to randomization, primarily due to not meeting inclusion/exclusion criteria (306 \[39.4%\] subjects). A total of 436 participants were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months. | 218 |
| Romosozumab Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. | 218 |
| Total | 436 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Decision by Sponsor | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 15 | 15 |
Baseline characteristics
| Characteristic | Romosozumab | Teriparatide | Total |
|---|---|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 7.4 | 71.2 years STANDARD_DEVIATION 7.7 | 71.5 years STANDARD_DEVIATION 7.5 |
| Age, Customized ≥ 65 to < 75 years | 83 Participants | 96 Participants | 179 Participants |
| Age, Customized < 65 years | 50 Participants | 48 Participants | 98 Participants |
| Age, Customized ≥ 75 years | 85 Participants | 74 Participants | 159 Participants |
| Femoral Neck BMD T-score | -2.49 T-score STANDARD_DEVIATION 0.67 | -2.43 T-score STANDARD_DEVIATION 0.66 | -2.46 T-score STANDARD_DEVIATION 0.66 |
| Lumbar Spine BMD T-score | -2.83 T-score STANDARD_DEVIATION 1.1 | -2.87 T-score STANDARD_DEVIATION 1.04 | -2.85 T-score STANDARD_DEVIATION 1.07 |
| Prior Fracture No | 0 Participants | 1 Participants | 1 Participants |
| Prior Fracture Yes | 218 Participants | 217 Participants | 435 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 23 Participants | 18 Participants | 41 Participants |
| Race/Ethnicity, Customized White | 191 Participants | 196 Participants | 387 Participants |
| Serum Type 1 Collagen C-telopeptide (sCTX) | 252.3 ng/L STANDARD_DEVIATION 136.4 | 260.1 ng/L STANDARD_DEVIATION 124.9 | 256.2 ng/L STANDARD_DEVIATION 130.7 |
| Sex: Female, Male Female | 218 Participants | 218 Participants | 436 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total Hip BMD T-score | -2.27 T-score STANDARD_DEVIATION 0.75 | -2.21 T-score STANDARD_DEVIATION 0.72 | -2.24 T-score STANDARD_DEVIATION 0.74 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 76 / 214 | 79 / 218 |
| serious Total, serious adverse events | 23 / 214 | 17 / 218 |
Outcome results
Primary
Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.
Time frame: Baseline, month 6 and month 12
Population: The primary efficacy analysis set includes randomized participants with a non-missing baseline and at least one post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | -0.6 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | 2.6 percent change | Standard Error 0.2 |
Comparison: The primary analysis to assess the treatment difference (Romosozumab - Teriparatide) employed a linear mixed effects model for repeated measures. The model included main effects for treatment group, visit (categorical), baseline sCTX, baseline hip DXA BMD value, machine type (categorical), and machine type-by-baseline value interaction (to adjust for the effect of machine type on baseline DXA BMD value) as fixed main effects using an unstructured within-subject variance-covariance structure.p-value: <0.000195% CI: [2.7, 3.8]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
Time frame: Baseline and month 12
Population: The primary efficacy analysis set with values at baseline and month 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | -3.6 percent change | Standard Error 0.3 |
| Romosozumab | Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | 1.1 percent change | Standard Error 0.3 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [3.9, 5.3]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
Time frame: Baseline and month 6
Population: The primary efficacy analysis set with values at baseline and month 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | -2.7 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | 0.7 percent change | Standard Error 0.2 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.8, 4]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
Time frame: Baseline and month 12
Population: The primary efficacy analysis set with values at baseline and month 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 | -0.7 percent change | Standard Error 0.4 |
| Romosozumab | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 | 2.5 percent change | Standard Error 0.4 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.1, 4.3]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
Time frame: Baseline and month 6
Population: The primary efficacy analysis set with values at baseline and month 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 | -1.0 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 | 2.1 percent change | Standard Error 0.2 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.4, 3.8]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Femoral Neck BMD at Month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline and month 12
Population: The primary efficacy analysis set with values at baseline and month 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Femoral Neck BMD at Month 12 | -0.2 percent change | Standard Error 0.3 |
| Romosozumab | Percent Change From Baseline in Femoral Neck BMD at Month 12 | 3.2 percent change | Standard Error 0.3 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.6, 4.2]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Femoral Neck BMD at Month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline and month 6
Population: The primary efficacy analysis set with values at baseline and month 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Femoral Neck BMD at Month 6 | -1.1 percent change | Standard Error 0.3 |
| Romosozumab | Percent Change From Baseline in Femoral Neck BMD at Month 6 | 2.1 percent change | Standard Error 0.3 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.5, 3.9]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
Time frame: Baseline and month 12
Population: The primary efficacy analysis set with values at baseline and month 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 | -0.2 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 | 3.4 percent change | Standard Error 0.2 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.9, 4.2]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
Time frame: Baseline and month 6
Population: The primary efficacy analysis set with values at baseline and month 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 | -0.8 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 | 2.3 percent change | Standard Error 0.2 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.5, 3.6]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline and month 12
Population: The primary efficacy analysis set with values at baseline and month 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | 5.4 percent change | Standard Error 0.4 |
| Romosozumab | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | 9.8 percent change | Standard Error 0.4 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [3.4, 5.4]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline and month 6
Population: The primary efficacy analysis set with values at baseline and month 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | 3.5 percent change | Standard Error 0.3 |
| Romosozumab | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | 7.2 percent change | Standard Error 0.3 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.9, 4.6]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Total Hip BMD at Month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline and month 12
Population: The primary efficacy analysis set with values at baseline and month 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Total Hip BMD at Month 12 | -0.5 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Total Hip BMD at Month 12 | 2.9 percent change | Standard Error 0.2 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.8, 4]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Total Hip BMD at Month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline and month 6
Population: The primary efficacy analysis set with values at baseline and month 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Total Hip BMD at Month 6 | -0.8 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Total Hip BMD at Month 6 | 2.3 percent change | Standard Error 0.2 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.5, 3.7]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Time frame: Baseline and month 12
Population: The primary efficacy analysis set with values at baseline and month 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12 | 0.0 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12 | 3.6 percent change | Standard Error 0.2 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.9, 4.2]Linear mixed effects repeated measures
Secondary
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Time frame: Baseline and month 6
Population: The primary efficacy analysis set with values at baseline and month 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 | -0.7 percent change | Standard Error 0.2 |
| Romosozumab | Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 | 2.4 percent change | Standard Error 0.2 |
Comparison: Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.p-value: <0.000195% CI: [2.6, 3.6]Linear mixed effects repeated measures