An Open-label, Single-arm Extension Study to Evaluate the... | NCT00325468

An Open-label, Single-arm Extension Study to Evaluate the... | NCT00325468 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMG 162	Experimental	AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42	Drug: AMG 162

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMG 162	Drug	AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42	AMG 162

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8		8 years
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8		8 years
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8		8 years

Secondary Outcomes

Measure	Description	Time Frame
Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8		8 years
Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8		8 years

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21159841	Derived	Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.

Label	URL
AmgenTrials clinical trials website	View source

Arm/Group Information

ID	Title	Description
FG000	Placebo	In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
FG001	Denosumab 210 mg Q6M	In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
FG002	Denosumab 30 mg Q3M	In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
FG003	Denosumab Continuous Treatment	In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
FG004	Alendronate 70mg QW	In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00023 subjects FG00117 subjects FG00214 subjects FG003124 subjects FG00422 subjects
COMPLETED		FG00012 subjects FG00112 subjects FG00210 subjects FG00390 subjects FG004
NOT COMPLETED		FG00011 subjects FG0015 subjects FG0024 subjects FG00334 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0011 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
BG001	Denosumab 210 mg Q6M

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Subjects with nonmissing value at parent study 20010223 baseline and Year 8

Posted

Oct 2012

Least Squares Mean

95% Confidence Interval

percent

8 years

ID	Title	Description
OG000	Placebo	In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
OG001	Denosumab 210 mg Q6M	In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Study Director	Amgen Inc.	866-572-6436

Condition Browse Module

ID	Term
D001851	Bone Diseases, Metabolic
D010024	Osteoporosis

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

Intervention Browse Module

ID	Term
D000069448	Denosumab

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White or Caucasian

Title	Measurements
	BG00018 BG00116 BG00212 BG003112 BG00420 BG005178

Black or African American

Title	Measurements
	BG0000 BG0010 BG0021 BG003

Hispanic or Latino

Title	Measurements
	BG0005 BG0011 BG0021 BG003

Asian

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Japanese

Title	Measurements
	BG0000 BG0010 BG0020 BG003

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Native Hawaiian or Other Pacific Islander

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Aborigine

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Other

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Baseline Bone Mineral Density T-score of Each Anatomic Site

A bone mineral density (BMD) T-score is unit-less and represents the difference, in terms of number of standard deviations, between a subject's BMD value and the average BMD value of a gender-specific young normal reference.

Mean

Standard Deviation

T-score

Title

Denominators

Categories

Lumbar spine BMD T-score

Title	Measurements
	BG000-2.36± 0.62 BG001-2.02± 1.16 BG002-1.29± 0.94 BG003-1.35± 0.87 BG004-1.64± 1.09 BG005-1.55± 0.96

Total hip BMD T-score

Title	Measurements
	BG000-1.63± 0.75 BG001-1.39± 0.67 BG002-1.05± 0.75 BG003

Distal 1/3 radius T-score

Title	Measurements
	BG000-1.91± 1.25 BG001-1.45± 0.98 BG002-1.14± 1.29 BG003

Secondary

Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8

Subjects with nonmissing value at parent study 20010223 baseline and Year 8

Posted

Oct 2012

Median

Inter-Quartile Range

percent

8 years

ID	Title	Description
OG000	Placebo	In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
OG001	Denosumab 210 mg Q6M	In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
OG002	Denosumab 30 mg Q3M	In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
OG003	Denosumab Continuous Treatment	In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
OG004	Alendronate 70mg QW	In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.

Units	Counts
Participants	OG00012 OG00112 OG00210 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-55.8(-66.7 to -24.4) OG001-44.7(-63.6 to -23.8) OG002-52.5(-60.4 to -27.1) OG003

Primary

Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Subjects with nonmissing value at parent study 20010223 baseline and Year 8

Posted

Oct 2012

Least Squares Mean

95% Confidence Interval

percent

8 years

ID	Title	Description
OG000	Placebo	In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
OG001	Denosumab 210 mg Q6M	In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
OG002	Denosumab 30 mg Q3M	In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
OG003	Denosumab Continuous Treatment	In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
OG004	Alendronate 70mg QW	In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.

Units	Counts
Participants	OG00012 OG00112 OG0029 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.1(-1.2 to 3.5) OG0014.3(2.0 to 6.6) OG0022.3(-0.5 to 5.1) OG003

Primary

Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Subjects with nonmissing value at parent study 20010223 baseline and Year 8

Posted

Oct 2012

Least Squares Mean

95% Confidence Interval

percent

8 years

ID	Title	Description
OG000	Placebo	In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
OG001	Denosumab 210 mg Q6M	In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
OG002	Denosumab 30 mg Q3M	In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
OG003	Denosumab Continuous Treatment	In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
OG004	Alendronate 70mg QW	In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.

Units	Counts
Participants	OG00011 OG00110 OG0029 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-5.2(-7.4 to -2.9) OG0011.4(-0.9 to 3.8) OG0020.6(-1.9 to 3.1) OG003

Secondary

Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8

Subjects with nonmissing value at parent study 20010223 baseline and Year 8

Posted

Oct 2012

Median

Inter-Quartile Range

percent

8 years

ID	Title	Description
OG000	Placebo	In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
OG001	Denosumab 210 mg Q6M	In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
OG002	Denosumab 30 mg Q3M	In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
OG003	Denosumab Continuous Treatment	In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
OG004	Alendronate 70mg QW	In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.

Units	Counts
Participants	OG00012 OG00113 OG00210 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-66.4(-90.8 to -27.3) OG001-72.0(-84.9 to -57.4) OG002-48.0(-87.9 to 26.8) OG003