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

Participant Flow

Recruitment Details
Pre-assignment Details


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
Period Title: Overall Study
Started	821	824	818
Completed	637	606	658
Not Completed	184	218	160

Baseline Characteristics

Arm/Group Title		Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide	Total
Arm/Group Description		Placebo identical in appearance to ...	BA058 80 mcg: BA058 80 mcg subcutan...	Blinded until after randomization, ...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Number of Participants With New Vertebral Fractures at 18 Months
Description	[Not Specified]
Description	[Not Specified]
Time Frame	18 months

Outcome Measure Data

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
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
Overall Number of Participants Analyzed	711	690	717
Measure Type: Number Unit of Measure: participants
	30	4	6

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]

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Basline and 18 months

Outcome Measure Data

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
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
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)

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.

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.

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline and 18 months

Outcome Measure Data

Analysis Population Description


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
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)

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.

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.

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline and 18 months

Outcome Measure Data

Analysis Population Description


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
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)

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.

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.

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	18 months

Outcome Measure Data

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
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
Overall Number of Participants Analyzed	821	824	818
Measure Type: Number Unit of Measure: Participants
	33	18	24

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]

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]

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	18 months

Outcome Measure Data

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
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
Overall Number of Participants Analyzed	820	822	818
Measure Type: Number Unit of Measure: Hypercalcemic events
	5	15	34

Adverse Events

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
All-Cause Mortality
	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events 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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

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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):

Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7:CD013424. doi: 10.1002/14651858.CD013424.pub2.

Cosman F, Peterson LR, Towler DA, Mitlak B, Wang Y, Cummings SR. Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial. J Clin Endocrinol Metab. 2020 Nov 1;105(11). pii: dgaa450. doi: 10.1210/clinem/dgaa450.

Saag KG, Williams SA, Wang Y, Weiss RJ, Cauley JA. Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture. Clin Ther. 2020 Jun;42(6):1099-1107.e1. doi: 10.1016/j.clinthera.2020.04.012. Epub 2020 Jun 6. Erratum in: Clin Ther. 2020 Oct;42(10):2117.

Leder BZ, Mitlak B, Hu MY, Hattersley G, Bockman RS. Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2020 Mar 1;105(3). pii: dgz162. doi: 10.1210/clinem/dgz162. Erratum in: J Clin Endocrinol Metab. 2020 Aug 1;105(8):.

Leder BZ, Zapalowski C, Hu MY, Hattersley G, Lane NE, Singer AJ, Dore RK. Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial. J Bone Miner Res. 2019 Dec;34(12):2213-2219. doi: 10.1002/jbmr.3848. Epub 2019 Sep 11.

Moreira CA, Fitzpatrick LA, Wang Y, Recker RR. Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: The ACTIVE phase 3 trial. Bone. 2017 Apr;97:314-319. doi: 10.1016/j.bone.2016.11.004. Epub 2016 Nov 5.

Cosman F, Hattersley G, Hu MY, Williams GC, Fitzpatrick LA, Black DM. Effects of Abaloparatide-SC on Fractures and Bone Mineral Density in Subgroups of Postmenopausal Women With Osteoporosis and Varying Baseline Risk Factors. J Bone Miner Res. 2017 Jan;32(1):17-23. doi: 10.1002/jbmr.2991. Epub 2016 Sep 28.

Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016 Aug 16;316(7):722-33. doi: 10.1001/jama.2016.11136. Erratum in: JAMA. 2017 Jan 24;317(4):442.

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

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