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Trial record 6 of 22 for:    paget's disease of bone

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

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ClinicalTrials.gov Identifier: NCT00051636
Recruitment Status : Completed
First Posted : January 15, 2003
Results First Posted : May 7, 2012
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Paget's Disease of Bone
Interventions Drug: Zoledronic Acid
Drug: Risedronate
Drug: Placebo to Risedronate
Drug: Placebo to Zoledronic Acid
Dietary Supplement: Calcium and Vitamin D
Enrollment 172
Recruitment Details  
Pre-assignment Details 172 participants entered period 1; of these, 127 were identified as treatment responders and entered the extended observation period 2. Responders defined as patient who had ≥75% decrease from baseline in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint of normal range) or SAP within normal range at 6 months.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Period Title: Period 1 - Core
Started 90 82
Completed 86 76
Not Completed 4 6
Reason Not Completed
Adverse Event             2             2
Protocol Violation             1             0
Withdrawal by Subject             1             2
Lost to Follow-up             0             2
Period Title: Period 2- Extended Observation Period
Started 75 52
Completed 5 [1] 22 [2]
Not Completed 70 30
Reason Not Completed
Lost to Follow-up             5             4
withdrew for nonclinical reason             12             7
Clinical reasons other than Paget's             9             2
Death             4             5
Amendment 6 Informed Consent Not Signed             40             12
[1]
Includes patients retreated for Paget's disease and patients discontinued when sponsor ended study
[2]
Includes patients retreated for Paget's disease
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid Total
Hide Arm/Group Description Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. Total of all reporting groups
Overall Number of Baseline Participants 90 82 172
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 82 participants 172 participants
70.4  (10.25) 72.1  (9.91) 71.2  (10.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 82 participants 172 participants
Female
28
  31.1%
21
  25.6%
49
  28.5%
Male
62
  68.9%
61
  74.4%
123
  71.5%
1.Primary Outcome
Title Number of Patients Who Achieve Therapeutic Response at 6 Months.
Hide Description Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 88 82
Measure Type: Number
Unit of Measure: participants
85 60
2.Secondary Outcome
Title Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28
Hide Description The percent change in serum alkaline phosphatase from baseline to day 28 was measured.
Time Frame Baseline and day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 79 79
Mean (Standard Deviation)
Unit of Measure: percent change
-48.8  (11.51) -28.4  (17.72)
3.Secondary Outcome
Title Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
Hide Description The percent change in serum C-telopeptide from baseline to day 10 was measured.
Time Frame Baseline and day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 75 72
Mean (Standard Deviation)
Unit of Measure: percent change
-85.4  (18.00) -36.7  (69.58)
4.Secondary Outcome
Title Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10
Hide Description The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.
Time Frame Baseline and day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Deviation)
Unit of Measure: Percent change
-90.3  (13.19) -29.9  (37.52)
5.Secondary Outcome
Title Time to First Therapeutic Response
Hide Description A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.
Time Frame 182 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all randomized patients.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 90 82
Median (Inter-Quartile Range)
Unit of Measure: Days
64
(61 to 65)
78
(64 to 178)
6.Secondary Outcome
Title Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline
Hide Description Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.
Time Frame Baseline and day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 88 82
Measure Type: Number
Unit of Measure: Participants
5 0
7.Secondary Outcome
Title Change in Pain Severity Score
Hide Description Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
Time Frame Baseline and day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 51 46
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.5  (1.77) -0.7  (2.22)
8.Secondary Outcome
Title Change in Pain Interference Score
Hide Description Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
Time Frame Baseline and day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 51 45
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.2  (1.97) 0.1  (1.72)
9.Secondary Outcome
Title Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
Hide Description Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.
Time Frame 8 years was the maximum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 75 52
Measure Type: Number
Unit of Measure: Participants
8 29
10.Secondary Outcome
Title Number of Participants With a Partial Disease Relapse During the Extended Observation Period
Hide Description Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.
Time Frame 8 years was the maximum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 75 52
Measure Type: Number
Unit of Measure: Participants
6 26
11.Secondary Outcome
Title Number of Participants With a Disease Relapse During the Extended Observation Period
Hide Description Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.
Time Frame 8 years was the maximum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description:
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Overall Number of Participants Analyzed 75 52
Measure Type: Number
Unit of Measure: Participants
0 7
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population consisted of all randomized patients who were exposed to study drug.
 
Arm/Group Title Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Hide Arm/Group Description Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
All-Cause Mortality
Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   5/89 (5.62%)   8/82 (9.76%) 
Cardiac disorders     
Acute coronary syndrome  1  0/89 (0.00%)  1/82 (1.22%) 
Gastrointestinal disorders     
Abdominal pain  1  0/89 (0.00%)  1/82 (1.22%) 
Abdominal pain upper  1  0/89 (0.00%)  1/82 (1.22%) 
Constipation  1  0/89 (0.00%)  1/82 (1.22%) 
Dysphagia  1  0/89 (0.00%)  1/82 (1.22%) 
General disorders     
Asthenia  1  1/89 (1.12%)  0/82 (0.00%) 
Difficulty in walking  1  1/89 (1.12%)  0/82 (0.00%) 
Pyrexia  1  0/89 (0.00%)  1/82 (1.22%) 
Rigors  1  0/89 (0.00%)  1/82 (1.22%) 
Hepatobiliary disorders     
Hepatic cyst  1  0/89 (0.00%)  1/82 (1.22%) 
Infections and infestations     
Cellulitis orbital  1  1/89 (1.12%)  0/82 (0.00%) 
Lower respiratory tract infection  1  0/89 (0.00%)  1/82 (1.22%) 
Staphylococcal infection  1  0/89 (0.00%)  1/82 (1.22%) 
Urinary tract infection  1  0/89 (0.00%)  1/82 (1.22%) 
Injury, poisoning and procedural complications     
Lower limb fracture  1  0/89 (0.00%)  1/82 (1.22%) 
Metabolism and nutrition disorders     
Hypocalcaemia  1  0/89 (0.00%)  1/82 (1.22%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/89 (1.12%)  0/82 (0.00%) 
Back pain  1  0/89 (0.00%)  1/82 (1.22%) 
Spinal column stenosis  1  1/89 (1.12%)  0/82 (0.00%) 
Nervous system disorders     
Embolic stroke  1  1/89 (1.12%)  0/82 (0.00%) 
Psychiatric disorders     
Confusional state  1  0/89 (0.00%)  1/82 (1.22%) 
Renal and urinary disorders     
Renal impairment  1  0/89 (0.00%)  1/82 (1.22%) 
Surgical and medical procedures     
Leg amputation  1  1/89 (1.12%)  0/82 (0.00%) 
Sympathectomy  1  1/89 (1.12%)  0/82 (0.00%) 
Vascular disorders     
Peripheral ischaemia  1  1/89 (1.12%)  0/82 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zoledronic Acid and Placebo to Risedronate Risedronate and Placebo to Zoledronic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   71/89 (79.78%)   58/82 (70.73%) 
Gastrointestinal disorders     
Constipation  1  5/89 (5.62%)  6/82 (7.32%) 
Diarrhoea  1  5/89 (5.62%)  3/82 (3.66%) 
Dyspepsia  1  7/89 (7.87%)  3/82 (3.66%) 
Nausea  1  10/89 (11.24%)  8/82 (9.76%) 
General disorders     
Fatigue  1  8/89 (8.99%)  5/82 (6.10%) 
Influenza like illness  1  6/89 (6.74%)  4/82 (4.88%) 
Oedema peripheral  1  5/89 (5.62%)  1/82 (1.22%) 
Pain  1  7/89 (7.87%)  5/82 (6.10%) 
Pyrexia  1  11/89 (12.36%)  1/82 (1.22%) 
Rigors  1  13/89 (14.61%)  0/82 (0.00%) 
Infections and infestations     
Influenza  1  8/89 (8.99%)  6/82 (7.32%) 
Nasopharyngitis  1  8/89 (8.99%)  10/82 (12.20%) 
Injury, poisoning and procedural complications     
Fall  1  8/89 (8.99%)  4/82 (4.88%) 
Metabolism and nutrition disorders     
Hypocalcaemia  1  5/89 (5.62%)  0/82 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  11/89 (12.36%)  15/82 (18.29%) 
Back pain  1  5/89 (5.62%)  8/82 (9.76%) 
Bone pain  1  9/89 (10.11%)  6/82 (7.32%) 
Myalgia  1  10/89 (11.24%)  4/82 (4.88%) 
Pain in extremity  1  9/89 (10.11%)  9/82 (10.98%) 
Nervous system disorders     
Dizziness  1  10/89 (11.24%)  3/82 (3.66%) 
Headache  1  10/89 (11.24%)  11/82 (13.41%) 
Lethargy  1  9/89 (10.11%)  1/82 (1.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00051636     History of Changes
Obsolete Identifiers: NCT00050258
Other Study ID Numbers: CZOL446H2304
ZOL446K2304 ( Other Identifier: Novartis Pharmaceuticals )
First Submitted: January 14, 2003
First Posted: January 15, 2003
Results First Submitted: April 5, 2012
Results First Posted: May 7, 2012
Last Update Posted: May 15, 2012