Change in Bone Mineral Density, Total Spine.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24. (NCT00542425)
Timeframe: 6 months
Intervention | Percent change from baseline (Mean) |
---|
Placebo | 1.22 |
BA058 20 µg | 3.30 |
BA058 40 µg | 5.21 |
BA058 80 µg | 6.11 |
Teriparatide | 5.47 |
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Change in Bone Mineral Density, Femoral Neck.
Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24. (NCT00542425)
Timeframe: 6 months
Intervention | Percent change from baseline (Mean) |
---|
Placebo | 0.79 |
BA058 20 µg | 2.69 |
BA058 40 µg | 2.20 |
BA058 80 µg | 3.07 |
Teriparatide | 1.07 |
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Change in Bone Mineral Density, Total Hip.
Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24. (NCT00542425)
Timeframe: 6 months
Intervention | Percent change from baseline (Mean) |
---|
Placebo | 0.39 |
BA058 20 µg | 1.43 |
BA058 40 µg | 1.97 |
BA058 80 µg | 2.60 |
Teriparatide | 0.45 |
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Change in Bone Mineral Density, Total Spine.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48. (NCT00542425)
Timeframe: 12 months
Intervention | Percent change from baseline (Mean) |
---|
Placebo | 0.74 |
BA058 20 µg | 5.14 |
BA058 40 µg | 9.84 |
BA058 80 µg | 12.94 |
Teriparatide | 8.63 |
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Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
(NCT01343004)
Timeframe: Baseline and 18 months
Intervention | percent change (Mean) |
---|
Placebo | -0.08 |
BA058 80 mcg (Abaloparatide) | 3.44 |
Teriparatide | 2.81 |
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Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
(NCT01343004)
Timeframe: Basline and 18 months
Intervention | percent change from baseline (Mean) |
---|
Placebo | 0.48 |
BA058 80 mcg (Abaloparatide) | 9.20 |
Teriparatide | 9.12 |
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Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
(NCT01343004)
Timeframe: 18 months
Intervention | Hypercalcemic events (Number) |
---|
Placebo | 5 |
BA058 80 mcg (Abaloparatide) | 15 |
Teriparatide | 34 |
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Number of Participants With Non-vertebral Fractures at 18 Months
(NCT01343004)
Timeframe: 18 months
Intervention | Participants (Number) |
---|
Placebo | 33 |
BA058 80 mcg (Abaloparatide) | 18 |
Teriparatide | 24 |
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Number of Participants With New Vertebral Fractures at 18 Months
(NCT01343004)
Timeframe: 18 months
Intervention | participants (Number) |
---|
Placebo | 30 |
BA058 80 mcg (Abaloparatide) | 4 |
Teriparatide | 6 |
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Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
(NCT01343004)
Timeframe: Baseline and 18 months
Intervention | percent change (Mean) |
---|
Placebo | -0.44 |
BA058 80 mcg (Abaloparatide) | 2.90 |
Teriparatide | 2.26 |
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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. (NCT01674621)
Timeframe: Baseline up to 6 Months
Intervention | Participants (Count of Participants) |
---|
Abaloparatide Transdermal (50 mcg) | 6 |
Abaloparatide Transdermal (100 mcg) | 5 |
Abaloparatide Transdermal (150 mcg) | 4 |
Abaloparatide Injection (80 mcg) | 1 |
Abaloparatide Transdermal Placebo (0 mcg) | 5 |
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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. (NCT01674621)
Timeframe: Baseline up to 6 Months
Intervention | Participants (Count of Participants) |
---|
Abaloparatide Transdermal (50 mcg) | 0 |
Abaloparatide Transdermal (100 mcg) | 0 |
Abaloparatide Transdermal (150 mcg) | 0 |
Abaloparatide Injection (80 mcg) | 0 |
Abaloparatide Transdermal Placebo (0 mcg) | 0 |
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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. (NCT01674621)
Timeframe: Baseline up to 6 Months
Intervention | Participants (Count of Participants) |
---|
Abaloparatide Transdermal (50 mcg) | 1 |
Abaloparatide Transdermal (100 mcg) | 0 |
Abaloparatide Transdermal (150 mcg) | 0 |
Abaloparatide Injection (80 mcg) | 0 |
Abaloparatide Transdermal Placebo (0 mcg) | 0 |
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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. (NCT01674621)
Timeframe: Baseline up to 7 Months
Intervention | Participants (Count of Participants) |
---|
Abaloparatide Transdermal (50 mcg) | 0 |
Abaloparatide Transdermal (100 mcg) | 0 |
Abaloparatide Transdermal (150 mcg) | 1 |
Abaloparatide Injection (80 mcg) | 2 |
Abaloparatide Transdermal Placebo (0 mcg) | 0 |
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Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
(NCT01674621)
Timeframe: Baseline, 6 Months
Intervention | Percent change (Mean) |
---|
Abaloparatide Transdermal (50 mcg) | -4.84 |
Abaloparatide Transdermal (100 mcg) | 5.22 |
Abaloparatide Transdermal (150 mcg) | -5.52 |
Abaloparatide Injection (80 mcg) | 17.30 |
Abaloparatide Transdermal Placebo (0 mcg) | 10.23 |
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Percent Change From Baseline in BMD of Forearm at 6 Months
Percent change in BMD as specified by DXA scans of the forearm. (NCT01674621)
Timeframe: Baseline, 6 Months
Intervention | Percent change (Mean) |
---|
Abaloparatide Transdermal (50 mcg) | -0.24 |
Abaloparatide Transdermal (100 mcg) | -0.16 |
Abaloparatide Transdermal (150 mcg) | 0.84 |
Abaloparatide Injection (80 mcg) | 0.33 |
Abaloparatide Transdermal Placebo (0 mcg) | 0.05 |
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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. (NCT01674621)
Timeframe: Baseline, 6 Months
Intervention | Percent change (Mean) |
---|
Abaloparatide Transdermal (50 mcg) | 0.97 |
Abaloparatide Transdermal (100 mcg) | 1.32 |
Abaloparatide Transdermal (150 mcg) | 1.49 |
Abaloparatide Injection (80 mcg) | 2.74 |
Abaloparatide Transdermal Placebo (0 mcg) | -0.02 |
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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. (NCT01674621)
Timeframe: Baseline, 6 Months
Intervention | Percent change (Mean) |
---|
Abaloparatide Transdermal (50 mcg) | 1.87 |
Abaloparatide Transdermal (100 mcg) | 2.33 |
Abaloparatide Transdermal (150 mcg) | 2.95 |
Abaloparatide Injection (80 mcg) | 5.80 |
Abaloparatide Transdermal Placebo (0 mcg) | 0.04 |
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Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
(NCT01674621)
Timeframe: Baseline, 6 Months
Intervention | Percent change (Mean) |
---|
Abaloparatide Transdermal (50 mcg) | -2.61 |
Abaloparatide Transdermal (100 mcg) | 1.65 |
Abaloparatide Transdermal (150 mcg) | -8.22 |
Abaloparatide Injection (80 mcg) | 41.11 |
Abaloparatide Transdermal Placebo (0 mcg) | 9.42 |
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Percent Change From Baseline in Serum Osteocalcin at 6 Months
(NCT01674621)
Timeframe: Baseline, 6 Months
Intervention | Percent change (Mean) |
---|
Abaloparatide Transdermal (50 mcg) | -4.37 |
Abaloparatide Transdermal (100 mcg) | 6.67 |
Abaloparatide Transdermal (150 mcg) | -3.83 |
Abaloparatide Injection (80 mcg) | 69.54 |
Abaloparatide Transdermal Placebo (0 mcg) | -4.21 |
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Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
(NCT01674621)
Timeframe: Baseline, 6 Months
Intervention | Percent change (Mean) |
---|
Abaloparatide Transdermal (50 mcg) | -17.26 |
Abaloparatide Transdermal (100 mcg) | -8.42 |
Abaloparatide Transdermal (150 mcg) | -16.63 |
Abaloparatide Injection (80 mcg) | 10.28 |
Abaloparatide Transdermal Placebo (0 mcg) | -6.76 |
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Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
(NCT01674621)
Timeframe: Baseline, 6 Months
Intervention | Percent change (Mean) |
---|
Abaloparatide Transdermal (50 mcg) | -12.76 |
Abaloparatide Transdermal (100 mcg) | 1.52 |
Abaloparatide Transdermal (150 mcg) | -6.78 |
Abaloparatide Injection (80 mcg) | 97.64 |
Abaloparatide Transdermal Placebo (0 mcg) | -7.26 |
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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. (NCT01674621)
Timeframe: Baseline up to 6 Months
,,,,
Intervention | Participants (Count of Participants) |
---|
| General appearance at Screening | General appearance at 6 months | Skin at Screening | Skin at 6 months | Head at Screening | Head at 6 months | Lungs at Screening | Lungs at 6 months | Breasts at Screening | Breasts at 6 months | Abdomen at Screening | Abdomen at 6 months | Lymph nodes at Screening | Lymph nodes at 6 months | Columna at Screening | Columna at 6 months | Extremities at Screening | Extremities at 6 months | Neurologic at Screening | Neurologic at 6 months |
---|
Abaloparatide Injection (80 mcg) | 1 | 1 | 14 | 14 | 5 | 4 | 1 | 1 | 3 | 4 | 9 | 9 | 0 | 0 | 4 | 3 | 23 | 25 | 2 | 3 |
Abaloparatide Transdermal (100 mcg) | 0 | 0 | 24 | 26 | 3 | 4 | 0 | 0 | 7 | 7 | 8 | 7 | 0 | 0 | 3 | 2 | 13 | 10 | 0 | 0 |
Abaloparatide Transdermal (150 mcg) | 0 | 1 | 17 | 16 | 2 | 3 | 0 | 0 | 3 | 3 | 4 | 3 | 1 | 0 | 7 | 7 | 14 | 14 | 0 | 0 |
Abaloparatide Transdermal (50 mcg) | 0 | 0 | 28 | 29 | 6 | 6 | 0 | 0 | 4 | 4 | 7 | 6 | 0 | 0 | 1 | 1 | 21 | 23 | 0 | 0 |
Abaloparatide Transdermal Placebo (0 mcg) | 0 | 0 | 21 | 17 | 1 | 2 | 1 | 0 | 11 | 10 | 4 | 3 | 0 | 1 | 1 | 1 | 21 | 21 | 1 | 1 |
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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. (NCT01674621)
Timeframe: Baseline up to 7 Months
,,,,
Intervention | Participants (Count of Participants) |
---|
| Hypertension | Blood Pressure Increased | Heart Rate increased | Dyspnoea | Dizziness |
---|
Abaloparatide Injection (80 mcg) | 0 | 1 | 0 | 1 | 1 |
Abaloparatide Transdermal (100 mcg) | 1 | 0 | 0 | 0 | 0 |
Abaloparatide Transdermal (150 mcg) | 0 | 1 | 1 | 0 | 0 |
Abaloparatide Transdermal (50 mcg) | 0 | 0 | 0 | 0 | 0 |
Abaloparatide Transdermal Placebo (0 mcg) | 0 | 0 | 0 | 0 | 0 |
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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. (NCT03512262)
Timeframe: Baseline, Month 12
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide | 8.4820 |
Placebo | 1.1654 |
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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. (NCT03512262)
Timeframe: Month 12
,
Intervention | percentage of participants (Number) |
---|
| BMD Increase >0% at All Three Sites | BMD Increase >3% at All Three Sites | BMD Increase >6% at All Three Sites |
---|
Abaloparatide | 67.2 | 31.9 | 9.2 |
Placebo | 15.2 | 1.5 | 0.0 |
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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." (NCT03512262)
Timeframe: Baseline through Month 12
,
Intervention | percentage of participants (Number) |
---|
| Osteopenia to Normal | Osteopenia to Osteoporosis | Osteoporosis to Normal | Osteoporosis to Osteopenia | Normal to Osteopenia or Osteoporosis |
---|
Abaloparatide | 8.8 | 0 | 2.9 | 57.1 | 0 |
Placebo | 8.0 | 12.0 | 0 | 12.8 | 0 |
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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. (NCT03512262)
Timeframe: Baseline, Month 6
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide | 1.3888 |
Placebo | 0.0267 |
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Number of Participants With New Clinical Fractures
Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit). (NCT03512262)
Timeframe: Baseline through Month 12
Intervention | Participants (Count of Participants) |
---|
Abaloparatide | 1 |
Placebo | 3 |
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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. (NCT03512262)
Timeframe: Baseline, Month 12
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide | -0.0138 |
Placebo | 0.7066 |
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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. (NCT03512262)
Timeframe: Baseline, Month 12
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide | 2.9766 |
Placebo | 0.1545 |
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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. (NCT03512262)
Timeframe: Baseline, Month 6
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide | 1.4790 |
Placebo | -0.1884 |
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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. (NCT03512262)
Timeframe: Baseline, Month 6
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide | 5.5436 |
Placebo | 0.6418 |
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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). (NCT03512262)
Timeframe: Baseline, Month 12
Intervention | percent change (Mean) |
---|
Abaloparatide | 89.639 |
Placebo | 15.359 |
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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. (NCT03512262)
Timeframe: Baseline, Month 12
Intervention | percent change (Mean) |
---|
Abaloparatide | 225.919 |
Placebo | 0.291 |
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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. (NCT03512262)
Timeframe: Baseline, Month 12
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide | 2.1351 |
Placebo | 0.0143 |
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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. (NCT03512262)
Timeframe: Baseline, Month 12
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide | 1.4358 |
Placebo | -0.1915 |
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Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3
Blood samples were taken to measure efficacy related markers of bone metabolism at Day 1, Month 1, and Month 3. (NCT03710889)
Timeframe: Baseline (Day 1), Months 1 and 3
Intervention | nanograms (ng)/milliliter (mL) (Median) |
---|
| Baseline | Change at Month 1 | Change at Month 3 |
---|
Abaloparatide | 54.990 | 119.155 | 141.130 |
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Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3
Blood samples were taken to measure efficacy-related markers of bone metabolism at Day 1, Month 1, and Month 3. (NCT03710889)
Timeframe: Baseline (Day 1), Months 1 and 3
Intervention | ng/mL (Median) |
---|
| Baseline | Change at Month 1 | Change at Month 3 |
---|
Abaloparatide | 0.460 | 0.052 | 0.311 |
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Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3
Change in dynamic histomorphometry indices was assessed in the cancellous envelope. (NCT03710889)
Timeframe: Baseline (Day 1), Month 3
Intervention | percentage of MS/BS (Mean) |
---|
| Baseline | Change at Month 3 |
---|
Abaloparatide | 5.74 | 18.66 |
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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. (NCT04064411)
Timeframe: Baseline, Month 12
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide-SC | 3.4159 |
Abaloparatide-sMTS | 1.9163 |
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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. (NCT04064411)
Timeframe: Baseline, Month 12
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide-SC | 10.8571 |
Abaloparatide-sMTS | 7.1361 |
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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. (NCT04064411)
Timeframe: Baseline, Month 12
Intervention | percent change (Least Squares Mean) |
---|
Abaloparatide-SC | 3.6995 |
Abaloparatide-sMTS | 1.9688 |
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Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29
(NCT04366726)
Timeframe: Baseline, 0 (predose) and 4 hours postdose on Day 29
Intervention | mmol/L (Mean) |
---|
| Day 29, predose | Day 29, postdose |
---|
Abaloparatide-sMTS | 0.051 | 0.006 |
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Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29
(NCT04366726)
Timeframe: Baseline, 0 (predose) and 4 hours postdose on Day 29
Intervention | millimoles/liter (mmol/L) (Mean) |
---|
| Day 29, predose | Day 29, postdose |
---|
Abaloparatide-sMTS | -0.031 | -0.002 |
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Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29
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. (NCT04366726)
Timeframe: Baseline, Day 29
Intervention | percent change (Mean) |
---|
Abaloparatide-sMTS | 103.16 |
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Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29
(NCT04366726)
Timeframe: Baseline, 0 (predose) and 30-minutes postdose on Day 29
Intervention | micromoles/liter (μmol/L) (Mean) |
---|
| Day 29, predose | Day 29, postdose |
---|
Abaloparatide-sMTS | -0.0030 | -0.0006 |
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Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
(NCT04366726)
Timeframe: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29
Intervention | picograms/milliliter (pg/mL) (Geometric Mean) |
---|
Abaloparatide-sMTS | 399.6 |
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Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29
(NCT04366726)
Timeframe: 0 (predose) and 4 hours postdose on Day 29
Intervention | hour*pg/mL (Geometric Mean) |
---|
Abaloparatide-sMTS | 604.7 |
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