Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Placebo
|
BA058 80 mcg (Abaloparatide)
|
Teriparatide
|
Arm/Group Description |
Placebo identical in appearance to ...
|
BA058 80 mcg: BA058 80 mcg subcutan...
|
Blinded until after randomization, ...
|
Arm/Group Description |
Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily
|
BA058 80 mcg: BA058 80 mcg subcutaneous daily
|
Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily
|
|
|
Placebo
|
BA058 80 mcg (Abaloparatide)
|
Teriparatide
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
|
|
Placebo
|
BA058 80 mcg (Abaloparatide)
|
Teriparatide
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
90/820 (10.98%) |
80/822 (9.73%) |
82/818 (10.02%) |
Blood and lymphatic system disorders |
|
|
|
Anaemia |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Cardiac disorders |
|
|
|
Myocardial ischaemia |
0/820 (0.00%) |
2/822 (0.24%) |
1/818 (0.12%) |
Supraventricular tachycardia |
0/820 (0.00%) |
2/822 (0.24%) |
1/818 (0.12%) |
Atrioventricular block |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Cardio-respiratory arrest |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Myocardial infraction |
2/820 (0.24%) |
1/822 (0.12%) |
0/818 (0.00%) |
Palpitations |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Acute coronary syndrome |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Acute myocardial infarction |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Angina pectoris |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Angina unstable |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Atrial fibrillation |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Cardiac failure congestive |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Cardiomyopathy |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Coronary artery stenosis |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Mitral valve stenosis |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Sinus bradycardia |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Ear and labyrinth disorders |
|
|
|
Vertigo |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Vestibular disorder |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Endocrine disorders |
|
|
|
Goitre |
1/820 (0.12%) |
1/822 (0.12%) |
2/818 (0.24%) |
Thyroid cyst |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Eye disorders |
|
|
|
Malculopathy |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Retinal artery occulusion |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Cataract |
2/820 (0.24%) |
0/822 (0.00%) |
1/818 (0.12%) |
Gastrointestinal disorders |
|
|
|
Gastric Ulcer |
0/820 (0.00%) |
2/822 (0.24%) |
1/818 (0.12%) |
Abdominal pain |
3/820 (0.37%) |
1/822 (0.12%) |
0/818 (0.00%) |
Colitis |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Constipation |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Duodenal ulcer |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Haemorrhoids |
1/820 (0.12%) |
1/822 (0.12%) |
1/818 (0.12%) |
Intestinal obstruction |
1/820 (0.12%) |
1/822 (0.12%) |
0/818 (0.00%) |
Pancreatitis acute |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Vomiting |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Change of bowel habit |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Diverticulum |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Enterocele |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Gastric haemorrhage |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Gastritis |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Gastrointestinal haemorrhage |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Inguinal hernia |
2/820 (0.24%) |
0/822 (0.00%) |
0/818 (0.00%) |
Large intestine polyp |
2/820 (0.24%) |
0/822 (0.00%) |
0/818 (0.00%) |
General disorders |
|
|
|
Chest pain |
2/820 (0.24%) |
1/822 (0.12%) |
1/818 (0.12%) |
Pyrexia |
1/820 (0.12%) |
1/822 (0.12%) |
0/818 (0.00%) |
Chest discomfort |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
General physical health deterioration |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Sudden death |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Hepatobiliary disorders |
|
|
|
Cholelithiasis |
0/820 (0.00%) |
3/822 (0.36%) |
1/818 (0.12%) |
Cholangitis |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Bile duct stenosis |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Biliary dyskinesia |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Cholecystitis acute |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Infections and infestations |
|
|
|
Sepsis |
0/820 (0.00%) |
2/822 (0.24%) |
0/818 (0.00%) |
Urinary tract infection |
1/820 (0.12%) |
2/822 (0.24%) |
0/818 (0.00%) |
Appendicitis |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Bronchiolitis |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Bronchitis |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Bronchopneumonia |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Influenza |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Pneumonia |
1/820 (0.12%) |
1/822 (0.12%) |
1/818 (0.12%) |
Bacterial infection |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Dengue fever |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Gastroenteritis |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Helicobacter infection |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Localised infection |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Nasopharyngitis |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Paronychia |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Pyelonephritis acute |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Respiratory tract infection |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Viral infection |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
Craniocerebral injury |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Fibula fracture |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Humerus fracture |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Incisional hernia |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Joint dislocation |
2/820 (0.24%) |
1/822 (0.12%) |
0/818 (0.00%) |
Ligament rupture |
1/820 (0.12%) |
1/822 (0.12%) |
0/818 (0.00%) |
Patella fracture |
1/820 (0.12%) |
1/822 (0.12%) |
0/818 (0.00%) |
Postoperative hernia |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Spinal compression fracture |
0/820 (0.00%) |
1/822 (0.12%) |
2/818 (0.24%) |
Upper limb fracture |
2/820 (0.24%) |
1/822 (0.12%) |
1/818 (0.12%) |
Ankle fracture |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Contusion |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Extradural haematoma |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Femur fracture |
3/820 (0.37%) |
0/822 (0.00%) |
0/818 (0.00%) |
Fracture displacement |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Hand fracture |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Lower limb fracture |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Lumbar vertebral fracture |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Meniscus injury |
3/820 (0.37%) |
0/822 (0.00%) |
2/818 (0.24%) |
Pelvic fracture |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Radius fracture |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Tibia fracture |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Ulna fracture |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Wrist fracture |
0/820 (0.00%) |
0/822 (0.00%) |
2/818 (0.24%) |
Investigations |
|
|
|
Weight decreased |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Blood glucose increased |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Body temperature increased |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Bronchoscopy |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Liver function test abnormal |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
Hypoglycaemia |
0/820 (0.00%) |
2/822 (0.24%) |
0/818 (0.00%) |
Hyperglycaemia |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Gout |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Hypercalcaemia |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Osteoarthritis |
1/820 (0.12%) |
3/822 (0.36%) |
3/818 (0.37%) |
Back pain |
3/820 (0.37%) |
2/822 (0.24%) |
1/818 (0.12%) |
Foot deformity |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Spinal column stenosis |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Spinal pain |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Arthralgia |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Arthritis reactive |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Lumbar spine stenosis |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Spinal osteoarthritis |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Spondylisthesis |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Breast cancer |
1/820 (0.12%) |
3/822 (0.36%) |
6/818 (0.73%) |
Adenocarcinoma of colon |
0/820 (0.00%) |
2/822 (0.24%) |
0/818 (0.00%) |
Breast cancer stage II |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Melanocytic naevus |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Pancreatic neoplasm |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Adenocarcinoma gastric |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Angiolipoma |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Benign neoplasm of thyroid gland |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Bile duct adenocarcinoma |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Breast neoplasm |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Chronic leukaemia |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Gastric neoplasm |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Gastrointestinal carcinoma |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Invasive ductal breast carcinoma |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Lung adenocarcinoma |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Lung neoplasm malignant |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Malignant melanoma |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Metastatic malignant melanoma |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Metastatic squamous cell carcinoma |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Myeloproliferative disorder |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Uterine cancer |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Nervous system disorders |
|
|
|
Transient ischaemic attack |
2/820 (0.24%) |
2/822 (0.24%) |
2/818 (0.24%) |
Depressed level of consciousness |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Hydrocephalus |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Intracranial aneurysm |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Radicular syndrome |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Sciatica |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Subarchnoid haemorrhage |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Syncope |
1/820 (0.12%) |
1/822 (0.12%) |
0/818 (0.00%) |
Tension headache |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Carpal tunnel syndrome |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Cerebrovascular accident |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Dizziness |
1/820 (0.12%) |
0/822 (0.00%) |
2/818 (0.24%) |
Ischaemic stroke |
3/820 (0.37%) |
0/822 (0.00%) |
0/818 (0.00%) |
Lacunar infarction |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Loss of consciousness |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
VIIth nerve paralysis |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Renal and urinary disorders |
|
|
|
Hydronephrosis |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Calculus urinary |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Reproductive system and breast disorders |
|
|
|
Ovarian cyst |
0/820 (0.00%) |
2/822 (0.24%) |
1/818 (0.12%) |
Postmenopausal haemorrhage |
0/820 (0.00%) |
2/822 (0.24%) |
0/818 (0.00%) |
Uterine prolapse |
2/820 (0.24%) |
2/822 (0.24%) |
1/818 (0.12%) |
Cervical dysplasia |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Cystocele |
0/820 (0.00%) |
0/822 (0.00%) |
3/818 (0.37%) |
Uterine polyp |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Bronchiectasis |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Dyspnoea |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Pulmonary embolism |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Sinus polyp |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Allergic bronchitis |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Pulmonary mass |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Skin and subcutaneous tissue disorders |
|
|
|
Dermititis allergic |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Drug eruption |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Hypersensitivity vasculitis |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Surgical and medical procedures |
|
|
|
Cholecystectomy |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Colporrhaphy |
1/820 (0.12%) |
1/822 (0.12%) |
0/818 (0.00%) |
Coronary angioplasty |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Hip arthroplasty |
0/820 (0.00%) |
1/822 (0.12%) |
0/818 (0.00%) |
Joint arthroplasty |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Knee arthroplasty |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Osteosynthesis |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Rectocele repair |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Removal of internal fixation |
1/820 (0.12%) |
0/822 (0.00%) |
0/818 (0.00%) |
Toe operation |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Vascular disorders |
|
|
|
Intermittent claudication |
0/820 (0.00%) |
1/822 (0.12%) |
1/818 (0.12%) |
Aortic dissection |
1/820 (0.12%) |
0/822 (0.00%) |
1/818 (0.12%) |
Essential hypertension |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
Hypertension |
2/820 (0.24%) |
0/822 (0.00%) |
2/818 (0.24%) |
Hypertensive crisis |
0/820 (0.00%) |
0/822 (0.00%) |
1/818 (0.12%) |
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Placebo
|
BA058 80 mcg (Abaloparatide)
|
Teriparatide
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
447/820 (54.51%) |
492/822 (59.85%) |
456/818 (55.75%) |
Cardiac disorders |
|
|
|
Palpitations |
3/820 (0.37%) |
42/822 (5.11%) |
13/818 (1.59%) |
Gastrointestinal disorders |
|
|
|
Constipation |
42/820 (5.12%) |
36/822 (4.38%) |
34/818 (4.16%) |
Nausea |
25/820 (3.05%) |
68/822 (8.27%) |
42/818 (5.13%) |
Infections and infestations |
|
|
|
Influenza |
39/820 (4.76%) |
52/822 (6.33%) |
34/818 (4.16%) |
Nasopharyngitis |
66/820 (8.05%) |
48/822 (5.84%) |
52/818 (6.36%) |
Upper respiratory tract infection |
63/820 (7.68%) |
68/822 (8.27%) |
73/818 (8.92%) |
Urinary tract infection |
38/820 (4.63%) |
43/822 (5.23%) |
41/818 (5.01%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
80/820 (9.76%) |
71/822 (8.64%) |
70/818 (8.56%) |
Back pain |
81/820 (9.88%) |
69/822 (8.39%) |
58/818 (7.09%) |
Pain in extremity |
49/820 (5.98%) |
40/822 (4.87%) |
42/818 (5.13%) |
Nervous system disorders |
|
|
|
Dizziness |
50/820 (6.10%) |
82/822 (9.98%) |
59/818 (7.21%) |
Headache |
49/820 (5.98%) |
62/822 (7.54%) |
51/818 (6.23%) |
Renal and urinary disorders |
|
|
|
Hypercalciuria |
74/820 (9.02%) |
93/822 (11.31%) |
102/818 (12.47%) |
Vascular disorders |
|
|
|
Hypertension |
52/820 (6.34%) |
59/822 (7.18%) |
41/818 (5.01%) |