| Primary | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. | Intent-to-Treat (ITT) Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0008.4820± 0.5353
- OG0011.1654± 0.7235
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | Missing values were imputed using a multiple imputation method. | <0.0001 | Significance level of 0.01. | Least Squares (LSM) Means Difference | 7.3165 | | | 2-Sided | 99 | 5.0668 | 9.5663 | | | | | Superiority | | |
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| Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 12 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change in Total Hip BMD From Baseline at Month 6 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 6 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12 | Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Distal One-third Radius BMD at Month 12 | Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12 | Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed is the total number of participants who had s-PINP evaluation at Baseline and Month 12. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12 | Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss). | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed is the total number of participants who had s-CTX evaluation at Baseline and Month 12. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Number of Participants With New Clinical Fractures | Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit). | ITT Population: All participants randomized into the study. | Posted | | Count of Participants | | Participants | | Baseline through Month 12 | | | | ID | Title | Description |
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| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent of Participants With Change in Disease Status | The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following:
- Lumbar spine > -2.5 and total hip BMD T-score > -2.5 and < -1.0
- Lumbar spine > -2.5 and < -1.0 and total hip BMD T-score > -2.5
- Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0.
| ITT Population: All participants randomized into the study. Here, overall number of participants analyzed is the total number of participants who had baseline evaluation and also had end of treatment BMD disease category evaluation (normal, osteopenia, and osteoporosis). . | Posted | | Number | | percentage of participants | | Baseline through Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip | Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory. | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12 | QCT scans were evaluated by a central imaging laboratory. | Only 2 participants per reporting group had volumetric BMD measured by QCT at baseline and Month 12, therefore, no data is reported here to maintain participant confidentiality. | Posted | | | | | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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| Secondary | Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12 | QCT scans were evaluated by a central imaging laboratory. | Only 2 participants per reporting group had volumetric BMD measured by QCT at baseline and Month 12, therefore, no data is reported here to maintain participant confidentiality. | Posted | | | | | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen. | | OG001 | Placebo | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen. |
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