Postmenopausal Osteoporosis
Conditions
Keywords
BA058, Abaloparatide-SC, abaloparatide, ACTIVExtend, osteoporosis, fracture, bone loss
Brief summary
The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).
Detailed description
To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Interventions
DRUGAlendronate
Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.
Sponsors
Radius Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Even though this is an open-label study, participants and Investigators who will be participating in this study (BA058-05-005) will remain blinded to the prior treatment assignment in Study BA058-05-003 (NCT02653417) until all participants completed the first 6 months of BA058-05-005 for prespecified data analysis. Complete data analysis for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417). 2. The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417).
Exclusion criteria
1. Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason. 2. Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline | Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. |
| Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. |
| Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. |
| Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. |
| Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. |
| Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 | Serum Chemistry laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: sodium (Low: ≤129; High: ≥148 milliequivalent per liter \[mEq/L\]), potassium (Low: ≤3.2; High: ≥5.5 mEq/L), albumin (\<2.5 grams \[g\]/deciliter \[dL\]), total protein (\<5 g/dL), glucose (Low: ≤54; High: \>125 mg/dL \[fasting\] or \>200 milligrams \[mg\]/dL \[random\]), creatinine (≥2.1 mg/dL), aspartate aminotransferase (AST) (≥5.1\*upper limit of normal \[ULN\]), alanine aminotransferase (ALT) (≥5.1\*ULN), alkaline phosphatase (AP) (≥3.1\*ULN), total bilirubin (≥1.51\*ULN \[with any increase in liver function tests\] ≥2.0\*ULN \[with normal liver function tests\]), creatine kinase (≥3.1\*ULN), total cholesterol (\>226 mg/dL), and total calcium (Low: ≤7.4; High: ≥11.6 mg/dL). Only the serum chemistry parameters with at least 1 participant with a notable laboratory value are presented. |
| Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 | Hematology laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Absolute Eosinophils (\>5000 cells/mm\^3), Absolute Lymphocytes (≤499 cells/mm\^3), Absolute Neutrophils (≤999 cells/mm\^3), % Eosinophils (\>50%), % Lymphocytes (≤5%), % Neutrophils (≤10%), Hemoglobin (Low: ≤9.4 g/dL; High: change from baseline ≥2.1 g/dL), Platelets (≤99000 cells/mm\^3), and White Blood Cells (Low: ≤1499 cells/mm\^3; High: ≥20001 cells/mm\^3). Only the hematology parameters with at least 1 participant with a notable laboratory value are presented. |
| Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only) | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 | Coagulation laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Activated Partial Thromboplastin Time (≥1.41\*ULN), Prothrombin Time (≥1.21\*ULN). Because the Activated Partial Thromboplastin Time was the only coagulation laboratory parameter with at least 1 participant with a notable laboratory value, this is the only parameter presented below. |
| Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 | Urine laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Glucose (2+), Protein (2+), Blood (\>50 red blood cells per high-power field \[rbc/hpf\]). |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 | A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), congenital anomaly/birth defect, or persistent or significant disability/incapacity. Intensity for each AE was defined as mild, moderate, or severe. AEs included both SAEs and non-serious AEs. AEs whose causal relation was characterized as Possible or Probable were considered as related to study drug. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Countries
Argentina, Brazil, Czechia, Denmark, Estonia, Hong Kong, Lithuania, Poland, Romania, United States
Participant flow
Recruitment details
Eligible participants who received abaloparatide or placebo in the double-blind study (BA058-05-003 \[Study 003\]), were enrolled to this open-label extension study. Complete results for Study 003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Pre-assignment details
The procedures performed for the Follow-up visit (Month 19) for Study 003 served as Baseline for Day 1 of Study BA058-05-005 (Study 005).
Participants by arm
| Arm | Count |
|---|---|
| Abaloparatide-SC/Alendronate Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 mcg SC daily for 18 months. | 558 |
| Placebo/Alendronate Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months. | 581 |
| Total | 1,139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 26 | 36 |
| Overall Study | Continuing Significant Deterioration | 9 | 3 |
| Overall Study | Death | 2 | 3 |
| Overall Study | Hypersensitivity to Alendronate | 0 | 1 |
| Overall Study | Inability to Complete Study Procedures | 1 | 7 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Other than Specified | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Refusal of Treatment | 4 | 6 |
| Overall Study | Withdrawal by Subject | 13 | 13 |
Baseline characteristics
| Characteristic | Abaloparatide-SC/Alendronate | Total | Placebo/Alendronate |
|---|---|---|---|
| Age, Customized 65 to <74 years | 351 Participants | 721 Participants | 370 Participants |
| Age, Customized <65 years | 106 Participants | 220 Participants | 114 Participants |
| Age, Customized ≥75 years | 101 Participants | 198 Participants | 97 Participants |
| Femoral Neck BMD T-Score | -1.951 T-score STANDARD_DEVIATION 0.656 | -2.077 T-score STANDARD_DEVIATION 0.687 | -2.196 T-score STANDARD_DEVIATION 0.695 |
| Lumbar Spine Bone Mineral Density (BMD) T-Score | -2.11 T-score STANDARD_DEVIATION 0.997 | -2.50 T-score STANDARD_DEVIATION 1.008 | -2.87 T-score STANDARD_DEVIATION 0.867 |
| Sex: Female, Male Female | 558 Participants | 1139 Participants | 581 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total Hip BMD T-Score | -1.63 T-score STANDARD_DEVIATION 0.742 | -1.78 T-score STANDARD_DEVIATION 0.765 | -1.93 T-score STANDARD_DEVIATION 0.758 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 145 / 553 | 158 / 580 |
| serious Total, serious adverse events | 65 / 553 | 58 / 580 |
Outcome results
Primary
Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline
Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Time frame: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Population: Study BA058-05-005 mITT Population: all Study BA058-05-003 mITT participants with a Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) evaluable radiologic assessment (spine X-ray). Study BA058-05-003 mITT population included all ITT participants with a pretreatment and postbaseline evaluable radiologic assessment during Study BA058-05-003.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abaloparatide-SC/Alendronate | Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline | 3 Participants |
| Placebo/Alendronate | Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline | 25 Participants |
Secondary
Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)
Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Time frame: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Population: Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abaloparatide-SC/Alendronate | Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | 2.7 percentage of events |
| Placebo/Alendronate | Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | 5.6 percentage of events |
Secondary
Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only)
Coagulation laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Activated Partial Thromboplastin Time (≥1.41\*ULN), Prothrombin Time (≥1.21\*ULN). Because the Activated Partial Thromboplastin Time was the only coagulation laboratory parameter with at least 1 participant with a notable laboratory value, this is the only parameter presented below.
Time frame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Population: All Study BA058-05-005 ITT participants who received 1 or more doses of alendronate (Study BA058-05-005 Safety Population) with available data for the respective coagulation parameter. Only participants with a notable laboratory value are presented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only) | 9 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only) | 4 Participants |
Secondary
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
Hematology laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Absolute Eosinophils (\>5000 cells/mm\^3), Absolute Lymphocytes (≤499 cells/mm\^3), Absolute Neutrophils (≤999 cells/mm\^3), % Eosinophils (\>50%), % Lymphocytes (≤5%), % Neutrophils (≤10%), Hemoglobin (Low: ≤9.4 g/dL; High: change from baseline ≥2.1 g/dL), Platelets (≤99000 cells/mm\^3), and White Blood Cells (Low: ≤1499 cells/mm\^3; High: ≥20001 cells/mm\^3). Only the hematology parameters with at least 1 participant with a notable laboratory value are presented.
Time frame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Population: All Study BA058-05-005 ITT participants who received 1 or more doses of alendronate (Study BA058-05-005 Safety Population) with available data for the respective hematology parameter. Only participants with a notable laboratory value are presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Absolute Neutrophils | 0 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Hemoglobin (Low) | 7 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Lymphocytes (Absolute Count or Percentage) | 15 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Hemoglobin (High) | 19 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Neutrophils (Absolute Count or Percentage) | 0 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Platelets | 1 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Absolute Lymphocytes | 15 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Platelets | 0 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Absolute Lymphocytes | 11 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Lymphocytes (Absolute Count or Percentage) | 11 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Absolute Neutrophils | 2 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Neutrophils (Absolute Count or Percentage) | 2 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Hemoglobin (Low) | 2 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Hemoglobin (High) | 17 Participants |
Secondary
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Serum Chemistry laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: sodium (Low: ≤129; High: ≥148 milliequivalent per liter \[mEq/L\]), potassium (Low: ≤3.2; High: ≥5.5 mEq/L), albumin (\<2.5 grams \[g\]/deciliter \[dL\]), total protein (\<5 g/dL), glucose (Low: ≤54; High: \>125 mg/dL \[fasting\] or \>200 milligrams \[mg\]/dL \[random\]), creatinine (≥2.1 mg/dL), aspartate aminotransferase (AST) (≥5.1\*upper limit of normal \[ULN\]), alanine aminotransferase (ALT) (≥5.1\*ULN), alkaline phosphatase (AP) (≥3.1\*ULN), total bilirubin (≥1.51\*ULN \[with any increase in liver function tests\] ≥2.0\*ULN \[with normal liver function tests\]), creatine kinase (≥3.1\*ULN), total cholesterol (\>226 mg/dL), and total calcium (Low: ≤7.4; High: ≥11.6 mg/dL). Only the serum chemistry parameters with at least 1 participant with a notable laboratory value are presented.
Time frame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Population: All Study BA058-05-005 ITT participants who received 1 or more doses of alendronate (Study BA058-05-005 Safety Population) with available data for the respective serum chemistry parameter. Only participants with a notable laboratory value are presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Cholesterol Total | 75 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Potassium (Low) | 1 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Glucose (Fasting; High) | 22 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Potassium (High) | 4 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Creatine Kinase | 2 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Sodium (Low) | 1 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Sodium (High) | 6 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Glucose (Random) | 1 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Alkaline Phosphatase | 1 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Sodium (Low) | 1 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Alkaline Phosphatase | 0 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Cholesterol Total | 73 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Creatine Kinase | 1 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Glucose (Fasting; High) | 18 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Glucose (Random) | 2 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Potassium (Low) | 3 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Potassium (High) | 3 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Sodium (High) | 2 Participants |
Secondary
Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)
Urine laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Glucose (2+), Protein (2+), Blood (\>50 red blood cells per high-power field \[rbc/hpf\]).
Time frame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Population: All Study BA058-05-005 ITT participants who received 1 or more doses of alendronate (Study BA058-05-005 Safety Population) with available data for the respective urine laboratory parameter. Only participants with a notable laboratory value are presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Glucose | 4 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Protein | 6 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Blood | 77 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Glucose | 3 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Protein | 6 Participants |
| Placebo/Alendronate | Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Blood | 50 Participants |
Secondary
Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)
Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Time frame: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Population: Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abaloparatide-SC/Alendronate | Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | 15 Participants |
| Placebo/Alendronate | Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | 32 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), congenital anomaly/birth defect, or persistent or significant disability/incapacity. Intensity for each AE was defined as mild, moderate, or severe. AEs included both SAEs and non-serious AEs. AEs whose causal relation was characterized as Possible or Probable were considered as related to study drug. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Population: Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abaloparatide-SC/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | TEAEs | 452 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | TEAEs Related to Study Treatment | 85 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | Severe TEAEs | 38 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | Serious TEAEs | 65 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | TEAEs Leading to Death | 0 Participants |
| Abaloparatide-SC/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | TEAEs Leading to Discontinuation | 30 Participants |
| Placebo/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | TEAEs Leading to Death | 2 Participants |
| Placebo/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | TEAEs | 466 Participants |
| Placebo/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | Serious TEAEs | 58 Participants |
| Placebo/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | TEAEs Related to Study Treatment | 80 Participants |
| Placebo/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | TEAEs Leading to Discontinuation | 36 Participants |
| Placebo/Alendronate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | Severe TEAEs | 40 Participants |
Secondary
Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Time frame: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Population: Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into Study BA058-05-003. Missing BMD data were imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide-SC/Alendronate | Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | 4.5113 percent change | Standard Deviation 4.8042 |
| Placebo/Alendronate | Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | 0.4649 percent change | Standard Deviation 3.7913 |
Secondary
Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Time frame: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Population: Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into Study BA058-05-003. Missing BMD data were imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide-SC/Alendronate | Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | 12.7921 percent change | Standard Deviation 7.979 |
| Placebo/Alendronate | Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | 3.5133 percent change | Standard Deviation 4.2765 |
Secondary
Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Time frame: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Population: Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into Study BA058-05-003. Missing BMD data were imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide-SC/Alendronate | Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | 5.4737 percent change | Standard Deviation 3.9884 |
| Placebo/Alendronate | Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | 1.3698 percent change | Standard Deviation 2.9712 |