Comparison of Teriparatide With Alendronate for Treating... | NCT00051558

ID	Type	Description	Link
B3D-US-GHBZ

Label	Type	Description	Intervention Names
A	Experimental	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months	Drug: Teriparatide Drug: Placebo
B	Active Comparator	Alendronate 10 mg/day oral plus injection placebo, 36 months	Drug: Alendronate Sodium Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Teriparatide	Drug	20 micrograms/day, injection, 36 months	A	LY333334

Measure	Description	Time Frame
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)	change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)	18 month endpoint

Measure	Description	Time Frame
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset	change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)	18 month endpoint
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician		Loma Linda	California

PubMed Identifier	Type	Citation	Retractions
27111239	Derived	Saag KG, Agnusdei D, Hans D, Kohlmeier LA, Krohn KD, Leib ES, MacLaughlin EJ, Alam J, Simonelli C, Taylor KA, Marcus R. Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide. Arthritis Rheumatol. 2016 Sep;68(9):2122-8. doi: 10.1002/art.39726.
19918047

ID	Title	Description
FG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
FG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)

change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients.

Posted

Least Squares Mean

Standard Error

grams per square centimeters

18 month endpoint

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000198 OG001195

Title

Denominators

Categories

Title	Measurements
	OG0000.059± 0.006 OG0010.028± 0.006

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.	ANOVA	ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.	<0.001	All comparisons were conducted using a 2-sided significance level of 0.05.						95						No	Superiority or Other

Secondary

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset

change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients (female only subset).

Posted

Least Squares Mean

Standard Error

grams per square centimeters

18 month endpoint

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.

Posted

Least Squares Mean

Standard Error

grams per square centimeters

3, 6, 12, 18, 24, 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.

Posted

Least Squares Mean

Standard Error

grams per square centimeters

3, 6, 12, and 18 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied.

Posted

Least Squares Mean

Standard Error

grams per square centimeters

24 and 36 months and Endpoint at 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied.

Posted

Least Squares Mean

Standard Error

grams per square centimeters

18, 24, 36 months, and 18 and 36 month endpoints

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.

Posted

Least Squares Mean

Standard Error

grams per square centimeters

18, 24, 36 months, and 18 and 36 month endpoints

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.

Posted

Least Squares Mean

Standard Error

grams per square centimeters

12, 18, 24, and 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)

The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.

Posted

Least Squares Mean

Standard Error

grams per square centimeters

12, 18, 24, and 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen

Subset of patients with measures of biochemical markers

Posted

Mean

Standard Error

percent

1, 6, 18, and 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen

Subset of patients with measures of biochemical markers.

Posted

Mean

Standard Error

percent

1, 6, 18, and 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase

Subset of patients with measures of biochemical markers

Posted

Mean

Standard Error

percent

1, 6, 18, and 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments

Subset of patients with measures of biochemical markers

Posted

Mean

Standard Error

percent

1, 6, 18, and 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin

Subset of patients with measures of biochemical markers

Posted

Mean

Standard Error

percent

1, 6, 18, and 36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Secondary

Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures

Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.

For vertebral fractures, only those patients with baseline and postbaseline spinal radiographs were included in the analysis.

Posted

Number

participants

36 months

ID	Title	Description
OG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
OG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0011 events1 affected214 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events1 affected214 at risk EG0011 events1 affected214 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Cardiac arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Cardiac failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0012 events2 affected214 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0012 events2 affected214 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Epidermolysis	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Blindness	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0012 events1 affected214 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0010 events0 affected214 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0010 events0 affected214 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected214 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Subileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Death	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0014 events4 affected214 at risk
Impaired healing	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Multi-organ failure	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Ulcer	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected214 at risk
Antiphospholipid syndrome	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Sarcoidosis	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Abscess bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Arthritis bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected214 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Bronchopneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0016 events2 affected214 at risk
Cardiac infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected214 at risk EG0013 events3 affected214 at risk
Chronic sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Corneal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Escherichia infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0012 events2 affected214 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Herpes zoster	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0010 events0 affected214 at risk
Intervertebral discitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Labyrinthitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Lobar pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0011 events1 affected214 at risk
Lung abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Lung infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Osteomyelitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected214 at risk EG0016 events6 affected214 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Salmonella sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0012 events2 affected214 at risk
Septic shock	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0012 events2 affected214 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Tracheobronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0015 events4 affected214 at risk
Urosepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Device failure	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected214 at risk EG0013 events3 affected214 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected214 at risk
Renal injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Suture rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected214 at risk EG0010 events0 affected214 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected214 at risk EG0010 events0 affected214 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected214 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected214 at risk EG0012 events2 affected214 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Renal cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Cervical myelopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Sensory disturbance	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected214 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Agitation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Confusional state	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Delusion	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0011 events1 affected214 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Prostatic intraepithelial neoplasia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 events5 affected214 at risk EG0012 events2 affected214 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected214 at risk EG0012 events2 affected214 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0013 events1 affected214 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected214 at risk EG0012 events2 affected214 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected214 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0012 events2 affected214 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0012 events2 affected214 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Arthrodesis	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected214 at risk EG0010 events0 affected214 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected214 at risk EG0012 events1 affected214 at risk
Surgery	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Vertebroplasty	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0012 events2 affected214 at risk
Arterial insufficiency	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0011 events1 affected214 at risk
Haematoma	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk
Shock	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Thrombophlebitis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected214 at risk
Venous thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected214 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00010 events10 affected214 at risk EG00116 events16 affected214 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00012 events11 affected214 at risk EG00112 events10 affected214 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00019 events18 affected214 at risk EG00116 events16 affected214 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected214 at risk EG00116 events15 affected214 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected214 at risk EG0018 events8 affected214 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00044 events36 affected214 at risk EG00123 events18 affected214 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00013 events13 affected214 at risk EG00112 events11 affected214 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00032 events20 affected214 at risk EG00122 events17 affected214 at risk
Influenza	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00024 events18 affected214 at risk EG00129 events24 affected214 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events7 affected214 at risk EG00121 events13 affected214 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00023 events15 affected214 at risk EG00124 events18 affected214 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00027 events20 affected214 at risk EG00131 events26 affected214 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00026 events21 affected214 at risk EG00123 events19 affected214 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00025 events24 affected214 at risk EG00128 events26 affected214 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00012 events10 affected214 at risk EG00115 events12 affected214 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected214 at risk EG00118 events18 affected214 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00020 events17 affected214 at risk EG00115 events15 affected214 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00023 events18 affected214 at risk EG00117 events14 affected214 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00019 events18 affected214 at risk EG00116 events16 affected214 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00012 events12 affected214 at risk EG0013 events3 affected214 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00017 events13 affected214 at risk EG0016 events4 affected214 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00021 events21 affected214 at risk EG00118 events18 affected214 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months			70		190
EG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months			64		177

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D010281	Parathyroid Hormone
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

ID	Title	Description
BG000	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
BG001	Alendronate	Alendronate 10 mg/day oral plus injection placebo, 36 months
BG002	Total	Total of all reporting groups