| Primary | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine. | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 | Abaloparatide Injection (80 mcg) | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months | | OG004 | Abaloparatide Transdermal Placebo (0 mcg) | Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months |
| | Units | Counts |
|---|
| Participants | - OG00047
- OG00146
- OG00243
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.87± 2.87
- OG0012.33± 2.96
- OG0022.95± 3.13
- OG003
|
|
| | 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 |
|---|
| | Dunnett's test | P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo. | 0.0066 | Threshold for significance at 0.05 level. | | | | | | | | | | | | | Superiority or Other (legacy) | | | | |
|
| Secondary | Percent Change From Baseline in BMD of Total Hip at 6 Months | Percent change in BMD as specified by DXA scans of the total hip. | mITT population included all participants with pre-treatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 | Abaloparatide Injection (80 mcg) | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months |
|
| Secondary | Percent Change From Baseline in BMD of Forearm at 6 Months | Percent change in BMD as specified by DXA scans of the forearm. | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 | Abaloparatide Injection (80 mcg) | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months |
|
| Secondary | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 | Abaloparatide Injection (80 mcg) | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months | | OG004 |
|
| Secondary | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 | Abaloparatide Injection (80 mcg) | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months | | OG004 |
|
| Secondary | Percent Change From Baseline in Serum Osteocalcin at 6 Months | | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 | Abaloparatide Injection (80 mcg) | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months | | OG004 |
|
| Secondary | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 | Abaloparatide Injection (80 mcg) | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months | | OG004 |
|
| Secondary | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 | Abaloparatide Injection (80 mcg) | Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months | |
|
| Secondary | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section. | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Posted | | Count of Participants | | Participants | | Baseline up to 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months |
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Posted | | Count of Participants | | Participants | | Baseline up to 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months |
|
| Secondary | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Posted | | Count of Participants | | Participants | | Baseline up to 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | | OG003 |
|
| Secondary | Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 | Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 <1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: <25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: <65.0 g/L or <4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, > 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Posted | | Count of Participants | | Participants | | Baseline up to 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months |
|
| Secondary | Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), >1.0 g%, or >10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: >6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: >20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: >3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Posted | | Count of Participants | | Participants | | Baseline up to 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) |
|
| Secondary | Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: >2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: >3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Posted | | Count of Participants | | Participants | | Baseline up to 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | | OG001 | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | | OG002 | Abaloparatide Transdermal (150 mcg) | Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months |
|