A Multi-Center, Randomized, Open-Label Study to Assess th... | NCT00515463

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Denosumab - Vial	Experimental	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.	Biological: denosumab
Denosumab - Prefilled syringe	Experimental	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.	Biological: denosumab

Name	Type	Description	Arm Group Labels	Other Names
denosumab	Biological	60 mg denosumab in 1mL	Denosumab - Vial
denosumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6	An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12	An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.	12 months
Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
FG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6

An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.

Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 6 months.

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe (PFS) on Day 1 and at Month 6.

Units	Counts
Participants	OG000140 OG001146

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

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						Risk Difference (RD)	0				95	-0.7	0.7			Risk difference > 0 indicates that incidence of binding anti-denosumab antibodies in denosumab PFS is greater than denosumab vial. 95% CI based on a normal approximation with continuity correction.	No	Superiority or Other

Secondary

Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12

An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.

Posted

Number

Participants

12 months

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12

Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.

Patients testing positive for binding antibodies to denosumab.

Posted

Month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Sodium Change From Baseline at Month 1

Laboratory chemistry sodium

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Sodium Change From Baseline at Month 6

Laboratory chemistry sodium

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Sodium Change From Baseline at Month 12

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

mmol/L

Baseline, Month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Potassium Change From Baseline at Month 1

Laboratory chemistry potassium

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Potassium Change From Baseline at Month 6

Laboratory chemistry potassium

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Potassium Change From Baseline at Month 12

Laboratory chemistry potassium

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Chloride Change From Baseline at Month 1

Laboratory chemistry chloride

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Chloride Change From Baseline at Month 6

Laboratory chemistry chloride

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Chloride Change From Baseline at Month 12

Laboratory chemistry chloride

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Bicarbonate Change From Baseline at Month 1

Laboratory chemistry bicarbonate

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Bicarbonate Change From Baseline at Month 6

Laboratory chemistry bicarbonate

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Bicarbonate Change From Baseline at Month 12

Laboratory chemistry bicarbonate

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Magnesium Change From Baseline at Month 1

Laboratory chemistry magnesium

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Magnesium Change From Baseline at Month 6

Laboratory chemistry magnesium

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Magnesium Change From Baseline at Month 12

Laboratory chemistry magnesium

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Blood Urea Nitrogen Change From Baseline at Month 1

Laboratory chemistry blood urea nitrogen

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Blood Urea Nitrogen Change From Baseline at Month 6

Laboratory chemistry blood urea nitrogen

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Blood Urea Nitrogen Change From Baseline at Month 12

Laboratory chemistry blood urea nitrogen

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Creatinine Change From Baseline at Month 1

Laboratory chemistry creatinine

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

umol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Creatinine Change From Baseline at Month 6

Laboratory chemistry creatinine

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

umol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Creatinine Change From Baseline at Month 12

Laboratory chemistry creatinine

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

umol/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Aspartate Amino Transferase Change From Baseline at Month 1

Laboratory chemistry aspartate amino transferase

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

U/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Aspartate Amino Transferase Change From Baseline at Month 6

Laboratory chemistry aspartate amino transferase

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

U/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Aspartate Amino Transferase Change From Baseline at Month 12

Laboratory chemistry aspartate amino transferase

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

U/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Alanine Amino Transferase Change From Baseline at Month 1

Laboratory chemistry alanine amino transferase

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

U/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Alanine Amino Transferase Change From Baseline at Month 6

Laboratory chemistry alanine amino transferase

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

U/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Alanine Amino Transferase Change From Baseline at Month 12

Laboratory chemistry alanine amino transferase

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

U/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Bilirubin Change From Baseline at Month 1

Laboratory chemistry total bilirubin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

umol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Bilirubin Change From Baseline at Month 6

Laboratory chemistry total bilirubin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

umol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Bilirubin Change From Baseline at Month 12

Laboratory chemistry total bilirubin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

umol/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Albumin Change From Baseline at Month 1

Laboratory chemistry albumin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

g/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Albumin Change From Baseline at Month 6

Laboratory chemistry albumin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

g/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Albumin Change From Baseline at Month 12

Laboratory chemistry albumin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

g/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Protein Change From Baseline at Month 1

Laboratory chemistry total protein

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

g/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Protein Change From Baseline at Month 6

Laboratory chemistry total protein

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

g/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Protein Change From Baseline at Month 12

Laboratory chemistry total protein

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

g/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Glucose Change From Baseline at Month 1

Laboratory chemistry glucose

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Glucose Change From Baseline at Month 6

Laboratory chemistry glucose

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Glucose Change From Baseline at Month 12

Laboratory chemistry glucose

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

mmol/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Red Blood Cells Change From Baseline at Month 1

Laboratory hematology red blood cells

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^12/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Red Blood Cells Change From Baseline at Month 6

Laboratory hematology red blood cells

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^12/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Red Blood Cells Change From Baseline at Month 12

Laboratory hematology red blood cells

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^12/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Hemoglobin Change From Baseline at Month 1

Laboratory hematology hemoglobin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

g/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Hemoglobin Change From Baseline at Month 6

Laboratory hematology hemoglobin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

g/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Hemoglobin Change From Baseline at Month 12

Laboratory hematology hemoglobin

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

g/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Reticulocytes Change From Baseline at Month 1

Laboratory hematology reticulocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Reticulocytes Change From Baseline at Month 6

Laboratory hematology reticulocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Reticulocytes Change From Baseline at Month 12

Laboratory hematology reticulocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Platelets Change From Baseline at Month 1

Laboratory hematology platelets

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Platelets Change From Baseline at Month 6

Laboratory hematology platelets

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Platelets Change From Baseline at Month 12

Laboratory hematology platelets

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

White Blood Cells Change From Baseline at Month 1

Laboratory hematology white blood cells

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

White Blood Cells Change From Baseline at Month 6

Laboratory hematology white blood cells

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

White Blood Cells Change From Baseline at Month 12

Laboratory hematology white blood cells

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Neutrophils Change From Baseline at Month 1

Laboratory hematology total neutrophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Neutrophils Change From Baseline at Month 6

Laboratory hematology total neutrophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Total Neutrophils Change From Baseline at Month 12

Laboratory hematology total neutrophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Eosinophils Change From Baseline at Month 1

Laboratory hematology eosinophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Eosinophils Change From Baseline at Month 6

Laboratory hematology eosinophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Eosinophils Change From Baseline at Month 12

Laboratory hematology eosinophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Basophils Change From Baseline at Month 1

Laboratory hematology basophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Basophils Change From Baseline at Month 6

Laboratory hematology basophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Basophils Change From Baseline at Month 12

Laboratory hematology basophils

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Lymphocytes Change From Baseline at Month 1

Laboratory hematology lymphocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Lymphocytes Change From Baseline at Month 6

Laboratory hematology lymphocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Lymphocytes Change From Baseline at Month 12

Laboratory hematology lymphocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Monocytes Change From Baseline at Month 1

Laboratory hematology monocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 1

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Monocytes Change From Baseline at Month 6

Laboratory hematology monocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 6

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Monocytes Change From Baseline at Month 12

Laboratory hematology monocytes

Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.

Posted

Mean

Standard Deviation

10^9/L

Baseline, month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3

Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.

Patients who received ≥ 1 dose of investigational product.

Posted

Number

Participants

Day 1 to Month 12

ID	Title	Description
OG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
OG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0011 affected156 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected156 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected156 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0012 affected156 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0011 affected156 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected156 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected156 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected156 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected156 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected156 at risk
Aortic stenosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk
Temporal arteritis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected156 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sinusitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 affected154 at risk EG0018 affected156 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 affected154 at risk EG00110 affected156 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected154 at risk EG00113 affected156 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected154 at risk EG00111 affected156 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected154 at risk EG0018 affected156 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected154 at risk EG0018 affected156 at risk

ID	Term
D001851	Bone Diseases, Metabolic
D010024	Osteoporosis

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

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
BG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Denosumab - Vial	Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.			7	154	32	154
EG001	Denosumab - Pre-filled Syringe	Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.			12	156	49	156