Trial Outcomes & Findings for Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis (NCT NCT01657162)
NCT ID: NCT01657162
Last Updated: 2020-12-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1139 participants
Primary outcome timeframe
Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
Results posted on
2020-12-11
Participant Flow
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.
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).
Participant milestones
| Measure |
Abaloparatide-SC/Alendronate
Participants received 70 milligrams (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 micrograms (mcg) subcutaneous (SC) daily for 18 months.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
558
|
581
|
|
Overall Study
Study 003 ITT Population
|
824
|
821
|
|
Overall Study
Study 003 Modified ITT (mITT) Population
|
690
|
711
|
|
Overall Study
Completed Study 003
|
606
|
637
|
|
Overall Study
Study 005 ITT Population
|
558
|
581
|
|
Overall Study
Study 005 Safety Population
|
553
|
580
|
|
Overall Study
Study 005 mITT Population
|
544
|
568
|
|
Overall Study
COMPLETED
|
499
|
506
|
|
Overall Study
NOT COMPLETED
|
59
|
75
|
Reasons for withdrawal
| Measure |
Abaloparatide-SC/Alendronate
Participants received 70 milligrams (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 micrograms (mcg) subcutaneous (SC) daily for 18 months.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
26
|
36
|
|
Overall Study
Withdrawal by Subject
|
13
|
13
|
|
Overall Study
Continuing Significant Deterioration
|
9
|
3
|
|
Overall Study
Refusal of Treatment
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Inability to Complete Study Procedures
|
1
|
7
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Hypersensitivity to Alendronate
|
0
|
1
|
|
Overall Study
Other than Specified
|
0
|
2
|
Baseline Characteristics
All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable lumbar spine BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
Baseline characteristics by cohort
| Measure |
Abaloparatide-SC/Alendronate
n=558 Participants
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.
|
Placebo/Alendronate
n=581 Participants
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.
|
Total
n=1139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
106 Participants
n=558 Participants
|
114 Participants
n=581 Participants
|
220 Participants
n=1139 Participants
|
|
Age, Customized
65 to <74 years
|
351 Participants
n=558 Participants
|
370 Participants
n=581 Participants
|
721 Participants
n=1139 Participants
|
|
Age, Customized
≥75 years
|
101 Participants
n=558 Participants
|
97 Participants
n=581 Participants
|
198 Participants
n=1139 Participants
|
|
Sex: Female, Male
Female
|
558 Participants
n=558 Participants
|
581 Participants
n=581 Participants
|
1139 Participants
n=1139 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=558 Participants
|
0 Participants
n=581 Participants
|
0 Participants
n=1139 Participants
|
|
Lumbar Spine Bone Mineral Density (BMD) T-Score
|
-2.11 T-score
STANDARD_DEVIATION 0.997 • n=556 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable lumbar spine BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
-2.87 T-score
STANDARD_DEVIATION 0.867 • n=581 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable lumbar spine BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
-2.50 T-score
STANDARD_DEVIATION 1.008 • n=1137 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable lumbar spine BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
|
Femoral Neck BMD T-Score
|
-1.951 T-score
STANDARD_DEVIATION 0.656 • n=555 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable femoral neck BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
-2.196 T-score
STANDARD_DEVIATION 0.695 • n=581 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable femoral neck BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
-2.077 T-score
STANDARD_DEVIATION 0.687 • n=1136 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable femoral neck BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
|
Total Hip BMD T-Score
|
-1.63 T-score
STANDARD_DEVIATION 0.742 • n=555 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable femoral neck BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
-1.93 T-score
STANDARD_DEVIATION 0.758 • n=581 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable femoral neck BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
-1.78 T-score
STANDARD_DEVIATION 0.765 • n=1136 Participants • All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable femoral neck BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=544 Participants
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.
|
Placebo/Alendronate
n=568 Participants
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.
|
|---|---|---|
|
Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline
|
3 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=558 Participants
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.
|
Placebo/Alendronate
n=581 Participants
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.
|
|---|---|---|
|
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
|
32 Participants
|
SECONDARY outcome
Timeframe: 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).
Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=558 Participants
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.
|
Placebo/Alendronate
n=581 Participants
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.
|
|---|---|---|
|
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
|
1.3698 percent change
Standard Deviation 2.9712
|
SECONDARY outcome
Timeframe: 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).
Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=558 Participants
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.
|
Placebo/Alendronate
n=581 Participants
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.
|
|---|---|---|
|
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
|
0.4649 percent change
Standard Deviation 3.7913
|
SECONDARY outcome
Timeframe: 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).
Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=558 Participants
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.
|
Placebo/Alendronate
n=581 Participants
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.
|
|---|---|---|
|
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 7.9790
|
3.5133 percent change
Standard Deviation 4.2765
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=558 Participants
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.
|
Placebo/Alendronate
n=581 Participants
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.
|
|---|---|---|
|
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
|
5.6 percentage of events
|
SECONDARY outcome
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24Population: Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate.
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.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=553 Participants
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.
|
Placebo/Alendronate
n=580 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
TEAEs
|
452 Participants
|
466 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
TEAEs Related to Study Treatment
|
85 Participants
|
80 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
TEAEs Leading to Death
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
TEAEs Leading to Discontinuation
|
30 Participants
|
36 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
Severe TEAEs
|
38 Participants
|
40 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
Serious TEAEs
|
65 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24Population: 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.
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.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=553 Participants
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.
|
Placebo/Alendronate
n=580 Participants
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.
|
|---|---|---|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Cholesterol Total
|
75 Participants
|
73 Participants
|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Creatine Kinase
|
2 Participants
|
1 Participants
|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Glucose (Fasting; High)
|
22 Participants
|
18 Participants
|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Potassium (Low)
|
1 Participants
|
3 Participants
|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Sodium (High)
|
6 Participants
|
2 Participants
|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Alkaline Phosphatase
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Glucose (Random)
|
1 Participants
|
2 Participants
|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Potassium (High)
|
4 Participants
|
3 Participants
|
|
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
Sodium (Low)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24Population: 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.
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.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=553 Participants
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.
|
Placebo/Alendronate
n=580 Participants
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.
|
|---|---|---|
|
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
Hemoglobin (Low)
|
7 Participants
|
2 Participants
|
|
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
Hemoglobin (High)
|
19 Participants
|
17 Participants
|
|
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
Platelets
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
Absolute Lymphocytes
|
15 Participants
|
11 Participants
|
|
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
Lymphocytes (Absolute Count or Percentage)
|
15 Participants
|
11 Participants
|
|
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
Absolute Neutrophils
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
Neutrophils (Absolute Count or Percentage)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24Population: 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.
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.
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=553 Participants
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.
|
Placebo/Alendronate
n=580 Participants
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.
|
|---|---|---|
|
Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only)
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24Population: 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.
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 \[rbc/hpf\]).
Outcome measures
| Measure |
Abaloparatide-SC/Alendronate
n=553 Participants
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.
|
Placebo/Alendronate
n=580 Participants
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.
|
|---|---|---|
|
Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)
Glucose
|
4 Participants
|
3 Participants
|
|
Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)
Protein
|
6 Participants
|
6 Participants
|
|
Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)
Blood
|
77 Participants
|
50 Participants
|
Adverse Events
Abaloparatide-SC/Alendronate
Serious events: 65 serious events
Other events: 145 other events
Deaths: 0 deaths
Placebo/Alendronate
Serious events: 58 serious events
Other events: 158 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abaloparatide-SC/Alendronate
n=553 participants at risk
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.
|
Placebo/Alendronate
n=580 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.52%
3/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Angina pectoris
|
0.36%
2/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
2/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Left ventricular failure
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.34%
2/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Ear and labyrinth disorders
Vertigo
|
0.72%
4/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Eye disorders
Retinal detachment
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Eye disorders
Visual impairment
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.34%
2/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
General disorders
Chest pain
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
General disorders
Oedema peripheral
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
General disorders
Pyrexia
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Hepatobiliary disorders
Drug induced liver injury
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Bronchopneumonia
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Gastroenteritis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Pericarditis infective
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Pneumonia
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.34%
2/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Pyelonephritis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Infections and infestations
Viral myositis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.52%
3/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.36%
2/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.34%
2/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
2/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.90%
5/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.69%
4/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.36%
2/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal neoplasm
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.34%
2/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
2/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Presyncope
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Sciatica
|
0.36%
2/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Transient global amnesia
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.72%
4/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Psychiatric disorders
Depression
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Psychiatric disorders
Major depression
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Psychiatric disorders
Psychotic disorder
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Renal and urinary disorders
Renal failure acute
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.34%
2/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Surgical and medical procedures
Nasal septal operation
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Vascular disorders
Essential hypertension
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.18%
1/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.00%
0/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
0.17%
1/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
Other adverse events
| Measure |
Abaloparatide-SC/Alendronate
n=553 participants at risk
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.
|
Placebo/Alendronate
n=580 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
40/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
8.8%
51/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
54/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
10.0%
58/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
36/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
5.9%
34/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
23/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
5.3%
31/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
|
Vascular disorders
Hypertension
|
4.9%
27/553 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
5.7%
33/580 • Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
|
Additional Information
Radius Head of Clinical Operations
Radius Health, Inc.
Phone: (617) 551-4700
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place