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Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women (ACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01343004
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoporosis
Postmenopausal Osteoporosis
Interventions Drug: Placebo
Drug: BA058 80 mcg
Drug: teriparatide
Enrollment 2463
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Hide 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

Period Title: Overall Study
Started 821 824 818
Completed 637 606 658
Not Completed 184 218 160
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide Total
Hide 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

Total of all reporting groups
Overall Number of Baseline Participants 821 824 818 2463
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 821 participants 824 participants 818 participants 2463 participants
68.7  (6.5) 68.9  (6.5) 68.8  (6.6) 68.8  (6.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 821 participants 824 participants 818 participants 2463 participants
Female
821
 100.0%
824
 100.0%
818
 100.0%
2463
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With New Vertebral Fractures at 18 Months
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (MITT) population included all patients with pre-treatment and end-of-treatment evaluable radiologic assessment (spine X-ray).
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Hide 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

Overall Number of Participants Analyzed 711 690 717
Measure Type: Number
Unit of Measure: participants
30 4 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BA058 80 mcg (Abaloparatide)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
Hide Description [Not Specified]
Time Frame Basline and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Hide 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

Overall Number of Participants Analyzed 821 823 818
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
0.48  (3.82) 9.20  (7.54) 9.12  (6.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BA058 80 mcg (Abaloparatide)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BA058 80 mcg (Abaloparatide), Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8155
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
3.Secondary Outcome
Title Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
Hide Description [Not Specified]
Time Frame Baseline and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Hide 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

Overall Number of Participants Analyzed 820 822 818
Mean (Standard Deviation)
Unit of Measure: percent change
-0.08  (2.77) 3.44  (3.51) 2.81  (3.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BA058 80 mcg (Abaloparatide)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BA058 80 mcg (Abaloparatide), Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
4.Secondary Outcome
Title Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
Hide Description [Not Specified]
Time Frame Baseline and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Hide 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

Overall Number of Participants Analyzed 820 822 818
Mean (Standard Deviation)
Unit of Measure: percent change
-0.44  (3.57) 2.90  (4.21) 2.26  (3.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BA058 80 mcg (Abaloparatide)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BA058 80 mcg (Abaloparatide), Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
5.Secondary Outcome
Title Number of Participants With Non-vertebral Fractures at 18 Months
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Hide 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

Overall Number of Participants Analyzed 821 824 818
Measure Type: Number
Unit of Measure: Participants
33 18 24
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BA058 80 mcg (Abaloparatide)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0318
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2304
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BA058 80 mcg (Abaloparatide), Teriparatide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3361
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all patients who received 1 or more doses of study medication
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Hide 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

Overall Number of Participants Analyzed 820 822 818
Measure Type: Number
Unit of Measure: Hypercalcemic events
5 15 34
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Hide 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

All-Cause Mortality
Placebo BA058 80 mcg (Abaloparatide) Teriparatide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
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%) 
Hide Other (Not Including Serious) Adverse Events
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%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Program Director
Organization: Radius Health, Inc.
Phone: (617) 551-4700
EMail: info@radiuspharm.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT01343004    
Other Study ID Numbers: BA058-05-003
ACTIVE Trial ( Other Identifier: Radius Health, Inc. )
First Submitted: April 26, 2011
First Posted: April 27, 2011
Results First Submitted: October 25, 2016
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017