Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women (NCT NCT01343004)
NCT ID: NCT01343004
Last Updated: 2017-03-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2463 participants
Primary outcome timeframe
18 months
Results posted on
2017-03-01
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
821
|
824
|
818
|
|
Overall Study
COMPLETED
|
637
|
606
|
658
|
|
Overall Study
NOT COMPLETED
|
184
|
218
|
160
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Placebo
n=821 Participants
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=824 Participants
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=818 Participants
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
Total
n=2463 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
|
Gender
Female
|
821 Participants
n=5 Participants
|
824 Participants
n=7 Participants
|
818 Participants
n=5 Participants
|
2463 Participants
n=4 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Modified intent-to-treat (MITT) population included all patients with pre-treatment and end-of-treatment evaluable radiologic assessment (spine X-ray).
Outcome measures
| Measure |
Placebo
n=711 Participants
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=690 Participants
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=717 Participants
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Number of Participants With New Vertebral Fractures at 18 Months
|
30 participants
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Basline and 18 monthsPopulation: Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.
Outcome measures
| Measure |
Placebo
n=821 Participants
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=823 Participants
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=818 Participants
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
|
0.48 percent change from baseline
Standard Deviation 3.82
|
9.20 percent change from baseline
Standard Deviation 7.54
|
9.12 percent change from baseline
Standard Deviation 6.28
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsPopulation: Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.
Outcome measures
| Measure |
Placebo
n=820 Participants
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=822 Participants
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=818 Participants
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
|
-0.08 percent change
Standard Deviation 2.77
|
3.44 percent change
Standard Deviation 3.51
|
2.81 percent change
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsPopulation: Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.
Outcome measures
| Measure |
Placebo
n=820 Participants
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=822 Participants
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=818 Participants
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
|
-0.44 percent change
Standard Deviation 3.57
|
2.90 percent change
Standard Deviation 4.21
|
2.26 percent change
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.
Outcome measures
| Measure |
Placebo
n=821 Participants
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=824 Participants
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=818 Participants
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Number of Participants With Non-vertebral Fractures at 18 Months
|
33 Participants
|
18 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Safety population included all patients who received 1 or more doses of study medication
Outcome measures
| Measure |
Placebo
n=820 Participants
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=822 Participants
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=818 Participants
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
|
5 Hypercalcemic events
|
15 Hypercalcemic events
|
34 Hypercalcemic events
|
Adverse Events
Placebo
Serious events: 90 serious events
Other events: 447 other events
Deaths: 0 deaths
BA058 80 mcg (Abaloparatide)
Serious events: 80 serious events
Other events: 492 other events
Deaths: 0 deaths
Teriparatide
Serious events: 82 serious events
Other events: 456 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=820 participants at risk
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=822 participants at risk
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=818 participants at risk
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/820
|
0.24%
2/822
|
0.12%
1/818
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/820
|
0.24%
2/822
|
0.12%
1/818
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Cardiac disorders
Myocardial infraction
|
0.24%
2/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Cardiac disorders
Palpitations
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Cardiac disorders
Angina pectoris
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Cardiac disorders
Angina unstable
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Cardiac disorders
Cardiac failure congestive
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Cardiac disorders
Cardiomyopathy
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Cardiac disorders
Coronary artery stenosis
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Cardiac disorders
Sinus bradycardia
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Endocrine disorders
Goitre
|
0.12%
1/820
|
0.12%
1/822
|
0.24%
2/818
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Eye disorders
Malculopathy
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Eye disorders
Retinal artery occulusion
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Eye disorders
Cataract
|
0.24%
2/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/820
|
0.24%
2/822
|
0.12%
1/818
|
|
Gastrointestinal disorders
Abdominal pain
|
0.37%
3/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.12%
1/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
1/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Diverticulum
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Gastrointestinal disorders
Enterocele
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.24%
2/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.24%
2/820
|
0.00%
0/822
|
0.00%
0/818
|
|
General disorders
Chest pain
|
0.24%
2/820
|
0.12%
1/822
|
0.12%
1/818
|
|
General disorders
Pyrexia
|
0.12%
1/820
|
0.12%
1/822
|
0.00%
0/818
|
|
General disorders
Chest discomfort
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
General disorders
General physical health deterioration
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
General disorders
Sudden death
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/820
|
0.36%
3/822
|
0.12%
1/818
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Infections and infestations
Sepsis
|
0.00%
0/820
|
0.24%
2/822
|
0.00%
0/818
|
|
Infections and infestations
Urinary tract infection
|
0.12%
1/820
|
0.24%
2/822
|
0.00%
0/818
|
|
Infections and infestations
Appendicitis
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Infections and infestations
Bronchitis
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Infections and infestations
Influenza
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Infections and infestations
Pneumonia
|
0.12%
1/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Infections and infestations
Bacterial infection
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Infections and infestations
Dengue fever
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Infections and infestations
Helicobacter infection
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Infections and infestations
Localised infection
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Infections and infestations
Paronychia
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Infections and infestations
Pyelonephritis acute
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Infections and infestations
Respiratory tract infection
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Infections and infestations
Viral infection
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.24%
2/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.12%
1/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.12%
1/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/820
|
0.12%
1/822
|
0.24%
2/818
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.24%
2/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.37%
3/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.37%
3/820
|
0.00%
0/822
|
0.24%
2/818
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/820
|
0.00%
0/822
|
0.24%
2/818
|
|
Investigations
Weight decreased
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Investigations
Blood glucose increased
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Investigations
Body temperature increased
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Investigations
Bronchoscopy
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Investigations
Liver function test abnormal
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/820
|
0.24%
2/822
|
0.00%
0/818
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
1/820
|
0.36%
3/822
|
0.37%
3/818
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.37%
3/820
|
0.24%
2/822
|
0.12%
1/818
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Musculoskeletal and connective tissue disorders
Lumbar spine stenosis
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Musculoskeletal and connective tissue disorders
Spondylisthesis
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
1/820
|
0.36%
3/822
|
0.73%
6/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/820
|
0.24%
2/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiolipoma
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic leukaemia
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Nervous system disorders
Transient ischaemic attack
|
0.24%
2/820
|
0.24%
2/822
|
0.24%
2/818
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Nervous system disorders
Sciatica
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Nervous system disorders
Subarchnoid haemorrhage
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Nervous system disorders
Syncope
|
0.12%
1/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Nervous system disorders
Tension headache
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Nervous system disorders
Dizziness
|
0.12%
1/820
|
0.00%
0/822
|
0.24%
2/818
|
|
Nervous system disorders
Ischaemic stroke
|
0.37%
3/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Renal and urinary disorders
Calculus urinary
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/820
|
0.24%
2/822
|
0.12%
1/818
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/820
|
0.24%
2/822
|
0.00%
0/818
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.24%
2/820
|
0.24%
2/822
|
0.12%
1/818
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/820
|
0.00%
0/822
|
0.37%
3/818
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Skin and subcutaneous tissue disorders
Dermititis allergic
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Surgical and medical procedures
Colporrhaphy
|
0.12%
1/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/820
|
0.12%
1/822
|
0.00%
0/818
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Surgical and medical procedures
Osteosynthesis
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Surgical and medical procedures
Rectocele repair
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.12%
1/820
|
0.00%
0/822
|
0.00%
0/818
|
|
Surgical and medical procedures
Toe operation
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/820
|
0.12%
1/822
|
0.12%
1/818
|
|
Vascular disorders
Aortic dissection
|
0.12%
1/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
|
Vascular disorders
Hypertension
|
0.24%
2/820
|
0.00%
0/822
|
0.24%
2/818
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/820
|
0.00%
0/822
|
0.12%
1/818
|
Other adverse events
| Measure |
Placebo
n=820 participants at risk
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg (Abaloparatide)
n=822 participants at risk
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Teriparatide
n=818 participants at risk
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.37%
3/820
|
5.1%
42/822
|
1.6%
13/818
|
|
Gastrointestinal disorders
Constipation
|
5.1%
42/820
|
4.4%
36/822
|
4.2%
34/818
|
|
Gastrointestinal disorders
Nausea
|
3.0%
25/820
|
8.3%
68/822
|
5.1%
42/818
|
|
Infections and infestations
Influenza
|
4.8%
39/820
|
6.3%
52/822
|
4.2%
34/818
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
66/820
|
5.8%
48/822
|
6.4%
52/818
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
63/820
|
8.3%
68/822
|
8.9%
73/818
|
|
Infections and infestations
Urinary tract infection
|
4.6%
38/820
|
5.2%
43/822
|
5.0%
41/818
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
80/820
|
8.6%
71/822
|
8.6%
70/818
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
81/820
|
8.4%
69/822
|
7.1%
58/818
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
49/820
|
4.9%
40/822
|
5.1%
42/818
|
|
Renal and urinary disorders
Hypercalciuria
|
9.0%
74/820
|
11.3%
93/822
|
12.5%
102/818
|
|
Vascular disorders
Hypertension
|
6.3%
52/820
|
7.2%
59/822
|
5.0%
41/818
|
|
Nervous system disorders
Dizziness
|
6.1%
50/820
|
10.0%
82/822
|
7.2%
59/818
|
|
Nervous system disorders
Headache
|
6.0%
49/820
|
7.5%
62/822
|
6.2%
51/818
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/\> 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/\> 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.
- Publication restrictions are in place
Restriction type: OTHER