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Trial record 48 of 150 for:    tetracycline

A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00887965
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : October 17, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Low Bone Mass
Low Bone Mineral Density
Osteoporosis
Postmenopausal Osteoporosis
Intervention Drug: Previous denosumab
Enrollment 15
Recruitment Details First subject enrolled on 02-JUN-09. Last subject enrolled on 28-APR-2010.
Pre-assignment Details  
Arm/Group Title Previous Denosumab
Hide Arm/Group Description Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Previous Denosumab
Hide Arm/Group Description Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
62.1  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Ethnic group: White or Caucasian  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
15
1.Primary Outcome
Title Number of Participants With Normal/Abnormal Bone Histology
Hide Description The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who had at least one evaluable biopsy
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
Normal lamellar bone 15
Normal mineralization 15
Osteoid 15
Osteomalacia 0
Marrow fibrosis 0
Clinically significant marrow abnormality 0
Woven bone 0
2.Secondary Outcome
Title Bone Histomorphometry: Cancellous Bone Volume
Hide Description Cancellous (trabecular) bone volume (Tb.V) is the relative volume of total cancellous bone measured (TV), expressed as percentage, that is occupied by trabeculae. Cancellous bone volume was measured using Fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of total volume
Fluorochrome labeling
13.765
(10.190 to 18.080)
TRAP staining
17.320
(12.540 to 23.230)
3.Secondary Outcome
Title Bone Histomorphometry: Trabecular Number
Hide Description Trabecular number (Tb.N) is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Tb.N is a measure of trabecular connectivity and decreases with bone loss.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: mm^-1
1.050
(1.000 to 1.160)
4.Secondary Outcome
Title Bone Histomorphometry: Trabecular Separation
Hide Description Trabecular separation (Tb.Sp) is the mean distance in mm between trabeculae (measured by integrated computer graphics). Tb.Sp increases with trabecular bone loss.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: μm
807.270
(705.690 to 896.110)
5.Secondary Outcome
Title Bone Histomorphometry: Trabecular Thickness
Hide Description Mean trabecular thickness (Tb.Th) is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Tb.Th is reduced by aging and osteoporosis.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: μm
131.465
(117.090 to 159.030)
6.Secondary Outcome
Title Bone Histomorphometry: Cortical Width
Hide Description Cortical width correlates with dual photon absorptiometric (DPX) measurements of bone density.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: μm
747.45
(524.50 to 845.40)
7.Secondary Outcome
Title Bone Histomorphometry: Surface Density
Hide Description Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: mm^2 /mm^3
2.110
(2.000 to 2.320)
8.Secondary Outcome
Title Bone Histomorphometry: Osteoblast - Osteoid Interface
Hide Description Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of osteoid surface
30.165
(8.990 to 41.210)
9.Secondary Outcome
Title Bone Histomorphometry: Osteoid Surface
Hide Description Osteoid surface is expressed as a percentage total bone surface.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of bone surface
3.280
(1.200 to 8.370)
10.Secondary Outcome
Title Bone Histomorphometry: Osteoid Width
Hide Description Osteoid thickness (width; O.Th) is the mean thickness of osteoid seams on cancellous surfaces. O.Th is normally <12.5 µm. Increased O.Th suggests abnormal mineralization (osteomalacia).
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: μm
7.675
(6.680 to 11.880)
11.Secondary Outcome
Title Bone Histomorphometry: Wall Thickness
Hide Description Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: μm
40.30
(38.10 to 53.30)
12.Secondary Outcome
Title Bone Histomorphometry: Eroded Surface/Bone Surface
Hide Description Eroded surface is expressed as a percentage of total bone surface.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of bone surface
0.525
(0.300 to 1.110)
13.Secondary Outcome
Title Bone Histomorphometry: Osteoclast Number - Length Based
Hide Description Osteoclast number expressed per mm of bone. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: 1/mm
Fluorochrome labeling
0.150
(0.047 to 0.214)
TRAP staining
0.122
(0.070 to 0.250)
14.Secondary Outcome
Title Bone Histomorphometry: Osteoclast Number - Surface Based
Hide Description Osteoclast number expressed per bone surface area. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: 1/100 mm
Fluorochrome labeling
15.0
(14.7 to 21.4)
TRAP staining
12.2
(7.0 to 25.0)
15.Secondary Outcome
Title Bone Histomorphometry: Single-label Surface
Hide Description Single-label surface is expressed as a percentage of total bone surface. The presence of a single label indicates that mineralization was occurring during only one labeling period.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of bone surface
2.655
(1.520 to 3.550)
16.Secondary Outcome
Title Bone Histomorphometry: Double-label Surface
Hide Description Double-label surface is expressed as a percentage of total bone surface. The presence of double labels indicates that normal bone mineralization was actively occurring over the labeling interval.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of bone surface
2.895
(1.610 to 4.230)
17.Secondary Outcome
Title Bone Histomorphometry: Total Mineralizing Surface
Hide Description Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of bone surface
4.470
(3.130 to 5.880)
18.Secondary Outcome
Title Bone Histomorphometry: Mineral Apposition Rate
Hide Description The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: μm/day
0.740
(0.630 to 0.890)
19.Secondary Outcome
Title Bone Histomorphometry: Adjusted Mineral Apposition Rate
Hide Description The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface).
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: μm/day
0.750
(0.410 to 1.340)
20.Secondary Outcome
Title Bone Histomorphometry: Bone Formation Rate - Surface Based
Hide Description Bone formation rate - surface based (BFR/BS) is the calculated rate at which cancellous bone surface is being replaced annually. BFR/BS is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface /total bone surface).
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: μm^3 /μm^2 /year
11.930
(10.560 to 14.860)
21.Secondary Outcome
Title Bone Histomorphometry: Bone Formation Rate - Volume Based
Hide Description Bone formation rate - volume based (BFR/BV) is the calculated rate at which cancellous bone volume is being replaced annually. BFR/BV is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume).
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percent of bone volume per year
18.780
(12.050 to 27.340)
22.Secondary Outcome
Title Bone Histomorphometry: Formation Period
Hide Description The formation period is the duration of an interval when a place on the bone surface is actively forming bone. The formation period is calculated as the wall width (thickness of new bone made in one cycle) divided by the mineral apposition rate.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: days
60.7
(32.4 to 88.4)
23.Secondary Outcome
Title Bone Histomorphometry: Activation Frequency
Hide Description The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency (Ac.f). Activation frequency is calculated as the bone formation rate / wall width.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: /year
0.261
(0.198 to 0.360)
24.Secondary Outcome
Title Bone Histomorphometry: Osteoid Volume
Hide Description Osteoid volume is expressed as a percentage of total bone volume.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of total volume
0.515
(0.120 to 1.360)
25.Secondary Outcome
Title Bone Histomorphometry: Mineralization Lag Time
Hide Description The mineralization lag time is the time interval between osteoid secretion and its subsequent mineralization, in days.
Time Frame 25-34 days post-Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one biopsy evaluable for histomorphometry.
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: days
11.9
(7.6 to 19.9)
26.Secondary Outcome
Title C-Telopeptide (CTX-1)
Hide Description C-Telopeptide is a biochemical marker for bone turnover. Blood samples were drawn for assessment of CTX-1 levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.
Time Frame Day 3 or Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one evaluable biopsy
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
0.646
(0.494 to 0.789)
27.Secondary Outcome
Title Procollagen Type 1 N-terminal Peptide (P1NP)
Hide Description Procollagen Type 1 N-terminal Peptide is a biochemical marker of bone turnover. Blood samples were drawn for assessment of P1NP levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.
Time Frame Day 3 or Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with at least one evaluable biopsy
Arm/Group Title Previous Denosumab
Hide Arm/Group Description:
Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: μg/L
50.70
(40.80 to 58.90)
Time Frame up to 50 days
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Previous Denosumab
Hide Arm/Group Description Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
All-Cause Mortality
Previous Denosumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Previous Denosumab
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Previous Denosumab
Affected / at Risk (%)
Total   15/15 (100.00%) 
Gastrointestinal disorders   
Dyspepsia  1  1/15 (6.67%) 
Nausea  1  2/15 (13.33%) 
Vomiting  1  1/15 (6.67%) 
Injury, poisoning and procedural complications   
Post procedural haematoma  1  6/15 (40.00%) 
Procedural pain  1  12/15 (80.00%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/15 (6.67%) 
Nervous system disorders   
Hypoaesthesia  1  1/15 (6.67%) 
Vascular disorders   
Hot flush  1  2/15 (13.33%) 
Hypertension  1  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator’s discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00887965     History of Changes
Other Study ID Numbers: 20080287
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: June 30, 2011
Results First Posted: October 17, 2013
Last Update Posted: November 15, 2013