A Study in Korean Postmenopausal Women With Osteoporosis... | NCT01457950

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase	Drug: denosumab
Arm 2	Placebo Comparator	placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase	Drug: placebo
Arm 3	Experimental	open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase	Drug: open-label denosumab

Name	Type	Description	Arm Group Labels	Other Names
denosumab	Drug	double-blind phase: 60mg subcutaneous injection, single dose	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6	Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline * 100.	Baseline and Month 6

Secondary Outcomes

Measure	Description	Time Frame
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1	Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline * 100.

Other Outcomes

Measure	Description	Time Frame
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab	Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ambulatory Korean postmenopausal women with osteoporosis
greater than 5 years postmenopausal
aged 60 to 90 years old
absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded.

Exclusion Criteria:

previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia
current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria
rheumatoid arthritis
cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal
medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates
medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists
malignancy within 5 years except certain resected types
malabsorption syndrome or gastrointestinal disorders associated with malabsorption
abnormal calcium level
vitamin D deficiency
any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results
severe renal impairment or on dialysis
impaired immune system or subject is taking immunosuppressants
oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery
any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures
any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results
known to have tested positive for HIV
less than two lumbar vertebrae evaluable for DXA measurements
height, weight, or girth that may preclude accurate DXA measurements
drug or alcohol abuse within 12 months that interferes with understanding or completing the study
known sensitivity to mammalian cell-derived drug products
use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s)

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Busan		602-739	South Korea
GSK Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
BG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
BG002	Total	Total of all reporting groups

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

Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6

Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline * 100.

Intent-to-Treat Efficacy (ITTE) Population: all participants who received one dose of study medication, and had a Baseline measure and at least one post-Baseline efficacy measure during the Double-Blind Treatment Phase.

Posted

Mean

Standard Error

Percent change

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants	OG00068 OG00166

Title

Denominators

Categories

Title	Measurements
	OG0004.10± 0.407 OG0010.89± 0.413

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		ANCOVA		<0.0001		Mean Difference (Final Values)	3.21			2-Sided	95	2.06	4.36				No	Superiority or Other

Secondary

Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1

Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline * 100.

ITTE Population

Posted

Mean

Standard Error

Percent change

Baseline and Month 1

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts

Secondary

Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6

Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline * 100.

ITTE Population

Posted

Mean

Standard Error

Percent change

Baseline, Month 1 and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Secondary

Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6

Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.

ITTE Population. Only participants at the specified time points were analyzed.

Posted

Median

Inter-Quartile Range

Percent change

Baseline, Months 1, 3 and 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Secondary

Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.

Intent-to-Treat (ITT) Population: all participants who received one dose of study medication.

Posted

Number

Participants

From Baseline up to Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Secondary

Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Ratio

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants

Secondary

Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Grams (G)/Liter (L)

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants

Secondary

Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed. .

Posted

Mean

Standard Deviation

Internationational Units(IU)/Liter (L)

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants

Secondary

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

10^9 cells per liter (GI/L)

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants

Secondary

Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Micromole/liter (UMOL/L)

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants

Secondary

Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimole/Liter (MMOL/L)

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants

Secondary

Change From Baseline in Hematocrit at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Proportion of RBCs in blood

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Corpuscle Hemoglobin at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Picograms (PG)/cell

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Corpuscular Volume at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Femtoliters (FL)

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Red Blood Cell Count at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

10^12 cells per liter (TI/L)

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Red Cell Distribution Width at Month 6

Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Mean

Standard Deviation

percentage (%) of mean RBC volume

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants

Secondary

Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6

Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Number

Participants

Baseline and Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts

Secondary

Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab

Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.

ITT Population. Only participants at the specified time points were analyzed.

Posted

Number

Participants

Month 6

ID	Title	Description
OG000	Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
OG001	Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).

Units	Counts
Participants

Other Pre-specified

Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab

Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.

Intent-to-Treat Open-Label (ITT-OL) Population: all participants from the ITT population in the Double-Blind Phase who continued into the Open-Label Extension Phase of the study and received denosumab at Month 6. Ony those participants with a value at Baseline and Month 12 were analyzed.

Posted

Mean

Standard Error

Percent change

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo

Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 * 100.

ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.

Posted

Mean

Standard Error

Percent change

Month 6 and Month 12

ID	Title	Description
OG000	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Units	Counts
Participants

Other Pre-specified

Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab

Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.

ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.

Posted

Mean

Standard Error

Percent change

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Units	Counts

Other Pre-specified

Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo

Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 * 100.

ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.

Posted

Mean

Standard Error

Percent change

Month 6 and Month 12

ID	Title	Description
OG000	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Units	Counts
Participants

Other Pre-specified

Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab

ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.

Posted

Median

Inter-Quartile Range

Percent change

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Units	Counts
Participants

Other Pre-specified

Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo

Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 * 100.

ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.

Posted

Median

Inter-Quartile Range

Percent change

Month 6 and Month 12

ID	Title	Description
OG000	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Units	Counts
Participants

Other Pre-specified

Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase

ITT-OL Population

Posted

Number

Participants

From Month 6 to Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg

Other Pre-specified

Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.

Posted

Mean

Standard Deviation

Ratio

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

Posted

Mean

Standard Deviation

Grams (G)/Liter (L)

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

Posted

Mean

Standard Deviation

Internationational Units(IU)/Liter (L)

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

Posted

Mean

Standard Deviation

10^9 cells per liter (GI/L)

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

Posted

Mean

Standard Deviation

Micromole/liter (UMOL/L)

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

Posted

Mean

Standard Deviation

Millimole/Liter (MMOL/L)

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change From Baseline in Hematocrit at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.

Posted

Mean

Standard Deviation

Proportion of RBCs in blood

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change From Baseline in Mean Corpuscle Hemoglobin at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.

Posted

Mean

Standard Deviation

Picograms (PG)/cell)

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change From Baseline in Red Blood Cell Count at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.

Posted

Mean

Standard Deviation

10^12 cells per liter (TI/L)

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Change From Baseline in Red Cell Distribution Width at Month 12

Change from Baseline was calculated as the Month 12 value minus the Baseline value.

ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.

Posted

Mean

Standard Deviation

percentage (%) of mean RBC volume

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12

ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.

Posted

Number

Participants

Baseline and Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Other Pre-specified

Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12

Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.

Posted

Number

Participants

Month 12

ID	Title	Description
OG000	Denosumab 60 mg to Open-Label Denosumab 60mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
OG001	Placebo to Open-Label Denosumab 60 mg	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Randomized Phase: Denosumab 60 mg	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).	7	69	13	69
EG001	Randomized Phase: Placebo	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).	2	66	11	66
EG002	Open Label Denosumab 60 mg (Previously Randomized Denosumab)	Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.	1	60	12	60
EG003	Open Label Denosumab 60 mg (Previously Randomized Placebo)	Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.	3	63	7	63

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG0030 affected63 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0011 affected66 at risk EG0020 affected60 at risk EG003
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0011 affected66 at risk EG0020 affected60 at risk EG003
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Skull fractured base	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Traumatic lung injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Macular hole	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0010 affected66 at risk EG0021 affected60 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0010 affected66 at risk EG0020 affected60 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected69 at risk EG0012 affected66 at risk EG0020 affected60 at risk EG0030 affected63 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected69 at risk EG0011 affected66 at risk EG0020 affected60 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected69 at risk EG0018 affected66 at risk EG0026 affected60 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0010 affected66 at risk EG0023 affected60 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0010 affected66 at risk EG0023 affected60 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected69 at risk EG0010 affected66 at risk EG0023 affected60 at risk EG003

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
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