Safety And Tolerability Study Of RN564 In Women With Oste... | NCT01293487

Safety And Tolerability Study Of RN564 In Women With Oste... | NCT01293487 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Arm 1	Experimental		Biological: RN564

Name	Type	Description	Arm Group Labels	Other Names
RN564	Biological	Intravenous, single dose with experimental dose	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)	Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose level was also be considered intolerable if, in the judgment of the Investigator and Sponsor, the type, frequency, or severity of AEs becomes unacceptable.	Day 1 to Day 85
Percentage of Participants With All-Causality AEs by Grade	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.	Day 1 to Day 85
Percentage of Participants With Treatment-Related AEs by Grade	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Relatedness to drug was assessed by investigator.

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ambulatory Diagnostic Center		Coral Gables	Florida	33134	United States
Gable Diagnostics

Label	URL
To obtain contact information for a study center near you, click here.	View source

Arm/Group Information

ID	Title	Description
FG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
FG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
FG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
FG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
FG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
FG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
FG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
FG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects FG0048 subjects FG0058 subjects FG0068 subjects FG00720 subjects
COMPLETED		FG0006 subjects FG0016 subjects FG0026 subjects FG0035 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects FG004

Type	Comment	Reasons
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
BG001	PF-04840082 1.0 mg/kg

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

Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)

Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose level was also be considered intolerable if, in the judgment of the Investigator and Sponsor, the type, frequency, or severity of AEs becomes unacceptable.

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Day 1 to Day 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg

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	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Atrial flutter	Cardiac disorders	MedDRA v.15.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v.15.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Pfizer ClinicalTrials.gov Call Center	Pfizer, Inc.	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

Condition Browse Module

ID	Term
D001851	Bone Diseases, Metabolic
D010024	Osteoporosis
D001847	Bone Diseases

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

Primary

Percentage of Participants With All-Causality AEs by Grade

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Number

percentage of participants

Day 1 to Day 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Grade 1

Title	Measurements
	OG000100.0 OG00150.0 OG002100.0 OG003

Primary

Percentage of Participants With Treatment-Related AEs by Grade

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Number

percentage of participants

Day 1 to Day 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Grade 1

Title	Measurements
	OG00050.0 OG00116.7 OG00250.0 OG003

Primary

Number of Participants With Any Laboratory Abnormality

Criteria for abnormality: hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function: blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN), urine casts, granular casts, hyaline casts>1 LPF; hormones: T4, T3, TSH<0.8*LLN.

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Day 1 to 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0013 OG0024 OG003

Primary

Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation

Median change from baseline in platelets, WBC count, lymphocytes (absolute [Abs]), total neutrophils (Abs), basophils (Abs), eosinophils (Abs), and monocytes (Abs)

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

10^3 cells/millimeter cube (mm^3)

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Platelets

Title

Measurements

OG0008(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-9(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

10^6 cells/mm^3

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title

Measurements

OG000-0.05(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.07(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Hematocrit at Last Observation

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

percentage of red blood cells

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title

Measurements

OG0000.6(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0011.4(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

grams/deciliter (g/dL)

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Hemoglobin (HGB)

Title

Measurements

OG000-0.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.6(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation

Includes median changes from baseline in total bilirubin, direct bilirubin, indirect bilirubin, blood urea nitrogen (BUN), creatinine, uric acid, calcium, magnesium, and glucose

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

milligrams/dL (mg/dL)

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Total Bilirubin

Title

Measurements

OG000-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

milliequivalents (mEq)/liter (L)

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Sodium

Title

Measurements

OG000-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Liver Function Tests at Last Observation

Includes median changes in aspartate aminotransferase (AST), alanine aminotransferase (AST), gamma glutamyltransferase (GGT), and alkaline phosphatase

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

international units (IU)/L

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Aminotransferase (AST)

Title

Measurements

OG000-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

micro IU (mIU)/mL

Baseline, Last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title

Measurements

OG0000(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

units (U)/L

Baseline, Last Observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Creatine Kinase (CK)

Title

Measurements

OG000-17(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG00121(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation

Safety Analysis Set: All participants who received at least 1 dose of study medication. Here "0" in the "overall number of participants analyzed" signifies that data not collected because none of the participants were evaluable for the specified arm.

Posted

Median

Full Range

nanograms (ng)/dL

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0000 OG0010 OG0026 OG003

Title

Denominators

Categories

T3 (free)

Title

Measurements

OG002-0.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-0.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007

Primary

Median Change From Baseline in T4 at Last Observation

Posted

Median

Full Range

micrograms (mcg)/dL

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title

Measurements

OG0000.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.9(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Median Change From Baseline in Urine WBC at Last Observation

Posted

Median

Full Range

/high-powered field (HPF)

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0000 OG0016 OG0020 OG003

Title

Denominators

Categories

Title

Measurements

OG001-1.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007

Primary

Median Change From Baseline in Urine pH at Last Observation

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Median

Full Range

Baseline, last observation (up to Day 85)

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title

Measurements

OG0000.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.7(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002

Primary

Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure

Participants with maximum changes from baseline (defined as increases or decreases of greater than or equal to [≥]20 mmHg or ≥30 mmHg) in either standing or supine systolic blood pressure (SBP) or diastolic blood pressure (DBP) measured in millimeters mercury (mmHg).

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Day 1 up to 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

≥30 mmHg decrease from baseline in supine SBP

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Primary

Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters

Participants with maximum changes from baseline (BSL) defined as: ≥25 to 50 percent (%) increase in maximum PR interval or QRS complex; increase from BSL of ≥30 milliseconds (msec) but <60 msec in corrected QT (QTc) interval or QTcF interval (QTc interval corrected using Fridericia's correction); or increase from BSL ≥60 msec in either QTc interval or QTcF interval.

Safety Analysis Set: All participants who received at least 1 dose of study medication.

Posted

Number

participants

Day 1 up to 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

≥25/50% increase from BSL in PR interval

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit

Safety Analysis Population

Posted

Number

Participants

Days -1, 8, 15, 29, 43, 57, and 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Day -1

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Pharmacokinetic (PK) Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= number of participants evaluable for this outcome measure.

Posted

Geometric Mean

Standard Deviation

mcg*h/mL

Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001175± 197.79 OG0017588± 1297.1 OG00286360± 12846 OG003

Secondary

Maximum Observed Serum Concentration (Cmax)

Posted

Geometric Mean

Standard Deviation

mcg/mL

Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0009.580± 0.69545 OG00129.20± 4.3353 OG002205.8± 29.743 OG003

Secondary

Time to Reach Maximum Observed Serum Concentration (Tmax)

Posted

Median

Full Range

hours

Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.49(1.00 to 4.00) OG0012.05(2.00 to 4.00) OG0022.00(1.12 to 4.00) OG003

Secondary

Volume of Distribution at Steady State (Vss)

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Posted

Geometric Mean

Standard Deviation

Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG000NA± NAVss could not be calculated for the 0.3 mg/kg dose since as per plan, reporting criteria for t1/2 were not met. The mean t1/2 could not be determined for the 0.3 mg/kg dose as the duration of sampling relative to the projected t1/2 was too short. OG0013817± 601.08 OG002

Secondary

Clearance (CL)

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= number of participants evaluable for this outcome measure and "0" in the "overall number of participants analyzed" signifies that data not collected because none of the participants were evaluable for the specified arm.

Posted

Geometric Mean

Standard Deviation

mL/hr

Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0000 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0017.647± 1.9804 OG0024.011± 0.72503 OG0045.729± 1.2399 OG005

Secondary

Terminal Elimination Half-Life (t1/2)

Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.

Posted

Mean

Standard Deviation

hours

Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG000NA± NAThe mean t1/2 could not be determined for the 0.3 mg/kg dose range as the duration of sampling relative to the projected t1/2 was too short. OG001358.7± 50.603 OG002

Secondary

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]

AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).

Posted

Geometric Mean

Standard Deviation

mcg*h/mL

Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG000NA± NAAUC(0-inf) could not be calculated for the 0.3 mg/kg dose since reporting criteria for t1/2 were not met. The mean t1/2 could not be determined for the 0.3 mg/kg dose range as the duration of sampling relative to the projected t1/2 was too short. OG0018655± 1390.4 OG002

Secondary

Apparent Volume of Distribution (Vz/F)

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Based on internal clinical pharmacology guidance on the most appropriate parameter calculations for this study design, data for Vz/F was not collected instead Vss was reported.

Based on internal clinical pharmacology guidance on the most appropriate parameter calculations for this study design, Vz/F was not reported. Instead, Vss was reported.

Posted

Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusion

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Percentage Change From Baseline in Total Dickkopf-1 (DKK-1) Concentrations Over Time

Pharmacodynamic (PD) Analysis Population: all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter in at least 1 treatment period. Analytical qualification of a total DKK-1 assay was unsuccessful, thus no data was collected and reported.

Posted

Day -1, Day 1 (predose and at end of infusion) and at 2, 4, 8, and 12 hours postdose, and Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57, and 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time

Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082

Pharmacodynamic (PD) Analysis Population: all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter in at least 1 treatment period; number analyzed=number of participants with an observation at the specified timepoints.

Posted

Mean

Standard Deviation

percentage change from baseline

Baseline (Days -1, 1), Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Day 2

Title	Measurements
	OG0000.161± 6.9455 OG0012.836± 6.4467 OG00211.237± 16.8782 OG003

Secondary

Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time

Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082

PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.

Posted

Mean

Standard Deviation

percentage change from baseline

Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Day 2

Title	Measurements
	OG000-4.602± 14.2023 OG001-6.789± 9.8119 OG002-1.247± 19.0705 OG003

Secondary

Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time

Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082

PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.

Posted

Mean

Standard Deviation

percentage change

Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Day 2

Title	Measurements
	OG0003.467± 7.6528 OG0016.218± 19.6492 OG00226.444± 16.5991 OG003

Secondary

Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time

Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082

PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.

Posted

Mean

Standard Deviation

percentage change

Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Day 2

Title	Measurements
	OG000-6.185± 6.3059 OG001-2.849± 3.8567 OG002-0.796± 7.4823 OG003

Secondary

Mean Percentage Change From Baseline in Serum Osteocalcin Over Time

Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082

PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.

Posted

Mean

Standard Deviation

percentage change

Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Day 2

Title	Measurements
	OG0005.734± 14.0949 OG0011.688± 11.1780 OG0024.798± 8.2785 OG003

Secondary

Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85

PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.

Posted

Mean

Standard Deviation

percentage change

Days -1 and 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

AP Spine L1 BMD

Title	Measurements
	OG000-4.096± 7.5769 OG0013.820± 2.8253 OG002-0.725± 2.8558 OG003

Secondary

Femoral Neck BMD at Day 85

BMD was evaluated by dual energy X-ray absorptiometry (DXA).

PD Analysis Population. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

Gram per centimeter square

Day 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.7308± 0.09688 OG0010.8357± 0.09877 OG0020.8135± 0.10100 OG003

Secondary

Femoral Neck T-Score at Day 85

BMD was evaluated by DXA. T-score was calculated based on actual measured bone density value and is the standardized scores that reflect the standard deviations (SDs) above/below the mean. A BMD T-score of -1.0 or more indicates normal bone density. T-score between -1.0 and -2.5 indicates low bone density known as osteopenia. A T-score of -2.5 or less is diagnostic of osteoporosis.

PD Analysis Population. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

T-score

Day 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-1.2833± 0.81833 OG001-0.7333± 1.55906 OG002-1.2833± 0.36009 OG003

Secondary

Mean Percentage Change From Baseline in Distal Radius BMD at Day 85

BMD was evaluated by DXA.

PD Analysis Population; Here, Overall number of participants analyzed=number of participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percentage change

Baseline (Day -1), Day 85

ID	Title	Description
OG000	PF-04840082 0.3 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG001	PF-04840082 1.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG002	PF-04840082 6.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG003	PF-04840082 24.0 mg/kg	Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG004	PF-04840082 3.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG005	PF-04840082 12.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG006	PF-04840082 18.0 mg/kg	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
OG007	Placebo	Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.

Units	Counts
Participants	OG0006 OG0016 OG0025 OG003

Title

Denominators

Categories

Radius BMD

Title	Measurements
	OG000-0.138± 3.3241 OG0011.673± 5.2845 OG002-1.545± 3.8933 OG003

White Blood Cell Count

Title

Measurements

OG000-0.8(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-0.5(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-0.9(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.8(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.4(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Lymphocytes (Abs)

Title

Measurements

OG000-0.10(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.06(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.06(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-0.06(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.07(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.05(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.09(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Total Neutrophils (Abs)

Title

Measurements

OG000-0.78(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.04(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-0.34(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-0.51(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-0.12(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.61(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-0.11(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.35(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Basophils (Abs)

Title

Measurements

OG0000.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0050.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Eosinophils (Abs)

Title

Measurements

OG0000.03(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.04(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0050.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Monocytes (Abs)

Title

Measurements

OG000-0.10(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.04(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-0.04(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.03(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.03(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.00(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Total Protein

Title

Measurements

OG000-0.5(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-0.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Albumin

Title

Measurements

OG000-0.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-0.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Direct Bilirubin

Title

Measurements

OG0000.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0050.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Indirect Bilirubin

Title

Measurements

OG000-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Blood Urea Nitrogen (BUN)

Title

Measurements

OG000-4.7(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0015.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-3.5(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0033.8(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-2.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0051.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0061.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.4(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Creatinine

Title

Measurements

OG000-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0050.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Uric Acid

Title

Measurements

OG000-1.0(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0051.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Calcium

Title

Measurements

OG000-0.2(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.2(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-0.2(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-0.2(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-0.1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0050.1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-0.1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.2(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Magnesium

Title

Measurements

OG000-0.1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-0.0(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.0(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.0(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0060.0(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.0(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Glucose

Title

Measurements

OG000-11(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0012(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0021(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0033(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-11(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-1(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070(NA to NA)Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Potassium

Title

Measurements

OG0000.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-0.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0.1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Chloride

Title

Measurements

OG000-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0030(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0041(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0052(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Bicarbonate (venous)

Title

Measurements

OG0000.2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0010.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0020.6(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-1.5(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-0.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-0.3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Alanine Aminotransferase (ALT)

Title

Measurements

OG0000(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0022(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0041(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0051(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-8(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Gamma GT

Title

Measurements

OG000-8(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-6(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0021(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG003-2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0044(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0063(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Alkaline Phosphatase

Title

Measurements

OG0001(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-5(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0024(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG00310(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0047(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-2(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-5(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG007-3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Amylase

Title

Measurements

OG0005(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG001-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0024(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0031(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0047(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-12(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

Lipase

Title

Measurements

OG000-1(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0015(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG002-8(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG00314(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG004-7(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG005-8(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG006-3(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0074(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.

T4 (free)

Title

Measurements

OG002-0.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0040.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
OG0070.0(NA to NA)Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.