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S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.

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: NCT00127205
Recruitment Status : Active, not recruiting
First Posted : August 5, 2005
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
NSABP Foundation Inc
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: clodronate disodium
Drug: ibandronate sodium
Drug: zoledronic acid
Enrollment 6097
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Zoledronate Arm II Clodronate Arm III Ibandronate
Hide Arm/Group Description

Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.

zoledronic acid: Given IV

Patients receive oral clodronate once daily for 35 months.

clodronate disodium: Given orally

Patients receive oral ibandronate once daily for 35 months.

ibandronate sodium: Given orally
Period Title: Overall Study
Started 2262 2268 1567
Completed 1427 1288 950
Not Completed 835 980 617
Reason Not Completed
Adverse Event             228             386             272
Death             8             6             6
Withdrawal by Subject             318             308             172
Other-non protocol specified             141             129             77
Under Review             13             21             6
Progression             127             130             84
Arm/Group Title Arm I Zoledronate Arm II Clodronate Arm III Ibandronate Total
Hide Arm/Group Description

Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.

zoledronic acid: Given IV

Patients receive oral clodronate once daily for 35 months.

clodronate disodium: Given orally

Patients receive oral ibandronate once daily for 35 months.

ibandronate sodium: Given orally

 Total of all reporting groups
Overall Number of Baseline Participants 2231 2235 1552 6018
Hide Baseline Analysis Population Description
Only eligible patients are included in the analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
53.0
(24.8 to 85.7)
52.6
(21.2 to 86.1)
52.7
(26.1 to 85.8)
52.7
(21.2 to 86.1)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age, Categorized Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
Age < 55
1270
  56.9%
1304
  58.3%
894
  57.6%
3468
  57.6%
Age >= 55
961
  43.1%
931
  41.7%
658
  42.4%
2550
  42.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
Female
2231
 100.0%
2235
 100.0%
1552
 100.0%
6018
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
American Indian or Alaska Native
12
   0.5%
8
   0.4%
4
   0.3%
24
   0.4%
Asian
70
   3.1%
90
   4.0%
57
   3.7%
217
   3.6%
Native Hawaiian or Other Pacific Islander
2
   0.1%
2
   0.1%
3
   0.2%
7
   0.1%
Black or African American
129
   5.8%
118
   5.3%
85
   5.5%
332
   5.5%
White
1975
  88.5%
1976
  88.4%
1374
  88.5%
5325
  88.5%
More than one race
12
   0.5%
5
   0.2%
2
   0.1%
19
   0.3%
Unknown or Not Reported
31
   1.4%
36
   1.6%
27
   1.7%
94
   1.6%
Nodal Status  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
Negative
1089
  48.8%
1152
  51.5%
784
  50.5%
3025
  50.3%
1~3
722
  32.4%
685
  30.6%
489
  31.5%
1896
  31.5%
>=4
404
  18.1%
385
  17.2%
267
  17.2%
1056
  17.5%
ER/PR  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
Negative (ER-, PR-)
480
  21.5%
487
  21.8%
319
  20.6%
1286
  21.4%
Positive (ER+ or PR+)
1747
  78.3%
1747
  78.2%
1231
  79.3%
4725
  78.5%
HER2 status  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
HER2 negative
1787
  80.1%
1786
  79.9%
1247
  80.3%
4820
  80.1%
HER2 positive/equivocal
418
  18.7%
427
  19.1%
288
  18.6%
1133
  18.8%
Breast disease subtype  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
ER+ or PR+, HER2-
1437
  64.4%
1419
  63.5%
1015
  65.4%
3871
  64.3%
ER+ or PR+, HER2+
292
  13.1%
312
  14.0%
205
  13.2%
809
  13.4%
ER/PR-, HER2- (triple neg)
350
  15.7%
367
  16.4%
232
  14.9%
949
  15.8%
ER/PR-, HER2+ (triple neg)
126
   5.6%
115
   5.1%
83
   5.3%
324
   5.4%
Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
Stage I
721
  32.3%
770
  34.5%
509
  32.8%
2000
  33.2%
Stage II
992
  44.5%
954
  42.7%
694
  44.7%
2640
  43.9%
Stage III
472
  21.2%
460
  20.6%
304
  19.6%
1236
  20.5%
[1]
Measure Description: Staging criterial is per AJCC 6th Edition, 2002. Higher staging means worse disease.
Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
Not given or planned
446
  20.0%
454
  20.3%
319
  20.6%
1219
  20.3%
Given or planned
1779
  79.7%
1778
  79.6%
1232
  79.4%
4789
  79.6%
Hormonal Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 2231 participants 2235 participants 1552 participants 6018 participants
Not given or planned
542
  24.3%
535
  23.9%
367
  23.6%
1444
  24.0%
Given or planned
1670
  74.9%
1686
  75.4%
1170
  75.4%
4526
  75.2%
1.Primary Outcome
Title Disease-free Survival
Hide Description Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.
Time Frame Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients will be included in the analysis.
Arm/Group Title Arm I Zoledronate Arm II Clodronate Arm III Ibandronate
Hide Arm/Group Description:

Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.

zoledronic acid: Given IV

Patients receive oral clodronate once daily for 35 months.

clodronate disodium: Given orally

Patients receive oral ibandronate once daily for 35 months.

ibandronate sodium: Given orally
Overall Number of Participants Analyzed 2231 2235 1552
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of analyzed participants
88
(87 to 90)
88
(86 to 89)
87
(86 to 89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I Zoledronate, Arm II Clodronate, Arm III Ibandronate
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I Zoledronate, Arm II Clodronate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.94 to 1.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I Zoledronate, Arm III Ibandronate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.90 to 1.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate.
Time Frame follow up completed every 6 months for 5 years and then annually for 5 years or until death
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients will be included in the analysis.
Arm/Group Title Arm I Zoledronate Arm II Clodronate Arm III Ibandronate
Hide Arm/Group Description:

Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.

zoledronic acid: Given IV

Patients receive oral clodronate once daily for 35 months.

clodronate disodium: Given orally

Patients receive oral ibandronate once daily for 35 months.

ibandronate sodium: Given orally
Overall Number of Participants Analyzed 2231 2235 1552
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of analyzable patients
93
(91 to 94)
92
(91 to 94)
93
(92 to 94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I Zoledronate, Arm II Clodronate, Arm III Ibandronate
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Distributions of Sites of First Recurrence on the Three Arms.
Hide Description All sites of invasive disease documented within 30 days of first documentation of invasive recurrence.
Time Frame Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Zoledronate Arm II Clodronate Arm III Ibandronate
Hide Arm/Group Description:

Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.

zoledronic acid: Given IV

Patients receive oral clodronate once daily for 35 months.

clodronate disodium: Given orally

Patients receive oral ibandronate once daily for 35 months.

ibandronate sodium: Given orally
Overall Number of Participants Analyzed 2231 2235 1552
Measure Type: Count of Participants
Unit of Measure: Participants
Local/Regional only
41
   1.8%
55
   2.5%
36
   2.3%
Contralateral only
17
   0.8%
18
   0.8%
17
   1.1%
Distant recurrence
218
   9.8%
207
   9.3%
146
   9.4%
Unknown location of recurrence
10
   0.4%
15
   0.7%
10
   0.6%
Bone as 1st site of distant recurrence
110
   4.9%
108
   4.8%
82
   5.3%
Bone only
62
   2.8%
48
   2.1%
44
   2.8%
Bone and nodes only
2
   0.1%
2
   0.1%
2
   0.1%
Bone and other distant sites (beside nodes)
46
   2.1%
58
   2.6%
36
   2.3%
Liver/lung/other visceral without bone recurrence
57
   2.6%
67
   3.0%
40
   2.6%
Brain/other CNS (+/- any other site)
31
   1.4%
24
   1.1%
22
   1.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I Zoledronate, Arm II Clodronate, Arm III Ibandronate
Comments Statistical analysis for recurrence to bone
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hide Description Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least one dose of protocol treatment.
Arm/Group Title Arm I Zoledronic Acid Arm II Clodronate Arm III Ibandronate
Hide Arm/Group Description:

Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.

zoledronic acid: Given IV

Patients receive oral clodronate once daily for 35 months.

clodronate disodium: Given orally

Arm III Ibandronate

Patients receive oral ibandronate once daily for 35 months.

ibandronate sodium: Given orally
Overall Number of Participants Analyzed 2113 2169 1518
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 1 3 1
AST, SGOT 1 5 3
Alkaline phosphatase 0 1 0
Allergic reaction/hypersensitivity 2 1 1
Anorexia 0 1 0
Arthritis (non-septic) 5 2 2
Auditory/Ear-Other (Specify) 1 0 0
Bilirubin (hyperbilirubinemia) 0 1 1
Blood/Bone Marrow-Other (Specify) 0 0 1
CNS cerebrovascular ischemia 0 1 0
Calcium, serum-low (hypocalcemia) 3 2 1
Cardiac General-Other (Specify) 0 0 1
Confusion 0 1 0
Constipation 0 1 1
Creatinine 2 1 4
Dehydration 1 2 0
Dental: periodontal disease 2 0 0
Dental: teeth 0 1 0
Diarrhea 2 11 5
Distention/bloating, abdominal 0 1 0
Dizziness 1 3 0
Dysphagia (difficulty swallowing) 0 1 1
Dyspnea (shortness of breath) 3 2 3
Edema: limb 1 1 4
Endocrine-Other (Specify) 0 1 0
Esophagitis 0 2 5
Extremity-upper (function) 0 0 1
Fatigue (asthenia, lethargy, malaise) 11 10 7
Febrile neutropenia 1 1 0
Fever in absence of neutropenia, ANC lt1.0x10e9/L 1 1 0
Flu-like syndrome 3 0 0
Fracture 0 3 1
Gastritis (including bile reflux gastritis) 0 1 1
Glucose, serum-high (hyperglycemia) 0 2 0
Heartburn/dyspepsia 2 22 22
Hemoglobin 3 2 1
Hemorrhage, GI - Rectum 0 1 0
Hemorrhage, GI - Stomach 0 0 1
Hot flashes/flushes 3 5 4
Hypertension 2 2 1
Hypotension 0 1 0
INR (of prothrombin time) 0 1 0
Incontinence, urinary 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 1 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Bone 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus 0 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Dental 0 1 1
Infection with unknown ANC - Appendix 0 0 1
Infection with unknown ANC - Liver 1 0 0
Infection with unknown ANC - Skin (cellulitis) 0 1 0
Insomnia 1 3 0
Irregular menses (change from baseline) 2 0 0
Irritability (children lt3 years of age) 0 1 0
Joint-function 0 0 1
Left ventricular systolic dysfunction 0 0 1
Leukocytes (total WBC) 2 1 0
Lymphopenia 2 3 0
Magnesium, serum-high (hypermagnesemia) 1 2 0
Magnesium, serum-low (hypomagnesemia) 1 0 0
Masculinization of female 0 0 1
Memory impairment 1 0 0
Metabolic/Laboratory-Other (Specify) 0 1 0
Mood alteration - anxiety 0 0 1
Mood alteration - depression 1 1 1
Mood alteration - euphoria 0 1 0
Mucositis/stomatitis (clinical exam) - Oral cavity 1 0 0
Muscle weakness, not d/t neuropathy - Extrem-lower 0 1 0
Muscle weakness, not d/t neuropathy - Extrem-upper 0 1 0
Muscle weakness, not d/t neuropathy - body/general 0 1 0
Nausea 3 5 2
Neuropathy: motor 0 0 1
Neuropathy: sensory 0 6 4
Neutrophils/granulocytes (ANC/AGC) 6 5 0
Obesity 1 1 0
Opportunistic inf associated w/gt=Gr 2 lymphopenia 1 0 0
Osteonecrosis (avascular necrosis) 6 1 3
Pain - Abdomen NOS 0 1 1
Pain - Back 3 2 6
Pain - Bone 47 19 19
Pain - Chest wall 0 1 0
Pain - Chest/thorax NOS 0 0 2
Pain - Extremity-limb 4 3 4
Pain - Head/headache 8 3 1
Pain - Joint 39 35 42
Pain - Muscle 23 5 16
Pain - Neck 1 0 1
Pain - Neuralgia/peripheral nerve 1 0 0
Pain - Oral cavity 0 0 1
Pain - Pain NOS 1 0 0
Pain - Stomach 1 1 1
Pain - Throat/pharynx/larynx 0 0 1
Pain - Vagina 0 0 1
Pain-Other (Specify) 4 4 0
Pancreatitis 0 1 0
Perforation, GI - Duodenum 0 1 0
Phosphate, serum-low (hypophosphatemia) 19 6 8
Platelets 1 0 0
Potassium, serum-high (hyperkalemia) 0 0 1
Potassium, serum-low (hypokalemia) 1 5 1
Proteinuria 0 0 1
Pruritus/itching 0 1 0
Rash/desquamation 0 3 2
Renal failure 2 2 5
Renal/Genitourinary-Other (Specify) 0 0 3
Retinal detachment 1 0 0
Rigors/chills 1 0 0
Secondary Malignancy-poss rel to cancer Tx 0 1 0
Sexual/Reproductive Function-Other (Specify) 1 0 1
Sodium, serum-low (hyponatremia) 0 1 0
Soft tissue necrosis - Head 0 0 1
Syncope (fainting) 2 0 0
Thrombosis/embolism (vascular access-related) 1 1 0
Thrombosis/thrombus/embolism 0 0 1
Tinnitus 1 0 0
Urticaria (hives, welts, wheals) 1 2 1
Vomiting 1 1 1
Weight gain 0 1 0
Weight loss 0 1 1
Time Frame Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
Adverse Event Reporting Description For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
 
Arm/Group Title Arm I Zoledronic Acid Arm II Clodronate Arm III Ibandronate
Hide Arm/Group Description

Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.

zoledronic acid: Given IV

Patients receive oral clodronate once daily for 35 months.

clodronate disodium: Given orally

Patients receive oral ibandronate once daily for 35 months.

ibandronate sodium: Given orally
All-Cause Mortality
Arm I Zoledronic Acid Arm II Clodronate Arm III Ibandronate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   238/2231 (10.67%)   263/2235 (11.77%)   182/1552 (11.73%) 
Hide Serious Adverse Events
Arm I Zoledronic Acid Arm II Clodronate Arm III Ibandronate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/2125 (0.99%)   190/2186 (8.69%)   141/1530 (9.22%) 
Blood and lymphatic system disorders       
Febrile neutropenia † 1  0/2125 (0.00%)  3/2186 (0.14%)  6/1530 (0.39%) 
Hemoglobin † 1  0/2125 (0.00%)  3/2186 (0.14%)  2/1530 (0.13%) 
Cardiac disorders       
Cardiac General-Other † 1  0/2125 (0.00%)  2/2186 (0.09%)  2/1530 (0.13%) 
Cardiac-ischemia/infarction † 1  1/2125 (0.05%)  1/2186 (0.05%)  4/1530 (0.26%) 
Conduction abnorm/AV block - Sick sinus syndrome † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Left ventricular diastolic dysfunction † 1  0/2125 (0.00%)  3/2186 (0.14%)  1/1530 (0.07%) 
Left ventricular systolic dysfunction † 1  0/2125 (0.00%)  1/2186 (0.05%)  4/1530 (0.26%) 
Pain - Cardiac/heart † 1  0/2125 (0.00%)  3/2186 (0.14%)  0/1530 (0.00%) 
Palpitations † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Pericardial effusion (non-malignant) † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
SVT and nodal arrhythmia - Atrial fibrillation † 1  0/2125 (0.00%)  4/2186 (0.18%)  1/1530 (0.07%) 
SVT and nodal arrhythmia - Atrial tachycardia/PAT † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
SVT and nodal arrhythmia - SVT tachycardia † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
SVT and nodal arrhythmia - Sinus bradycardia † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
SVT and nodal arrhythmia - Sinus tachycardia † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Valvular heart disease † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Ventricular arrhythmia - PVCs † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Ventricular arrhythmia - Ventricular fibrillation † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Endocrine disorders       
Endocrine-Other † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Eye disorders       
Ocular/Visual-Other † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Vision-blurred vision † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Gastrointestinal disorders       
Colitis † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Constipation † 1  0/2125 (0.00%)  0/2186 (0.00%)  2/1530 (0.13%) 
Dental: periodontal disease † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Diarrhea † 1  0/2125 (0.00%)  4/2186 (0.18%)  2/1530 (0.13%) 
Distention/bloating, abdominal † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Esophagitis † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Fistula, GI - Colon/cecum/appendix † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Gastritis (including bile reflux gastritis) † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Gastrointestinal-Other † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Hemorrhage, GI - Cecum/appendix † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Hemorrhage, GI - Esophagus † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Hemorrhage, GI - Stomach † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Hemorrhage, GI - Varices (rectal) † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Nausea † 1  0/2125 (0.00%)  2/2186 (0.09%)  5/1530 (0.33%) 
Obstruction, GI - Cecum † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Obstruction, GI - Small bowel NOS † 1  0/2125 (0.00%)  5/2186 (0.23%)  0/1530 (0.00%) 
Obstruction, GI - Stomach † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Pain - Abdomen NOS † 1  0/2125 (0.00%)  10/2186 (0.46%)  2/1530 (0.13%) 
Pancreatitis † 1  0/2125 (0.00%)  3/2186 (0.14%)  2/1530 (0.13%) 
Perforation, GI - Duodenum † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Ulcer, GI - Stomach † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Vomiting † 1  0/2125 (0.00%)  2/2186 (0.09%)  3/1530 (0.20%) 
General disorders       
Death not associated with CTCAE term - Death NOS † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Edema: head and neck † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Edema: limb † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Fatigue (asthenia, lethargy, malaise) † 1  0/2125 (0.00%)  4/2186 (0.18%)  0/1530 (0.00%) 
Pain - Chest/thorax NOS † 1  0/2125 (0.00%)  0/2186 (0.00%)  3/1530 (0.20%) 
Pain - Pain NOS † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Pain-Other † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Sudden death † 1  1/2125 (0.05%)  1/2186 (0.05%)  0/1530 (0.00%) 
Syndromes-Other † 1  1/2125 (0.05%)  1/2186 (0.05%)  0/1530 (0.00%) 
Hepatobiliary disorders       
Cholecystitis † 1  0/2125 (0.00%)  4/2186 (0.18%)  7/1530 (0.46%) 
Liver dysfunction/failure (clinical) † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Pain - Liver † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Immune system disorders       
Allergic reaction/hypersensitivity † 1  0/2125 (0.00%)  4/2186 (0.18%)  0/1530 (0.00%) 
Infections and infestations       
Inf (clin/microbio) w/Gr 3-4 neuts - Blood † 1  0/2125 (0.00%)  3/2186 (0.14%)  1/1530 (0.07%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Skin † 1  1/2125 (0.05%)  0/2186 (0.00%)  0/1530 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Colon † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Kidney † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung † 1  0/2125 (0.00%)  4/2186 (0.18%)  3/1530 (0.20%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lymphatic † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin † 1  0/2125 (0.00%)  16/2186 (0.73%)  12/1530 (0.78%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss † 1  0/2125 (0.00%)  1/2186 (0.05%)  2/1530 (0.13%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Wound † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod † 1  0/2125 (0.00%)  0/2186 (0.00%)  2/1530 (0.13%) 
Infection with normal ANC or Grade 1 or 2 neutroph † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Infection with unknown ANC - Appendix † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Infection with unknown ANC - Blood † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Infection with unknown ANC - Bronchus † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Infection with unknown ANC - Catheter-related † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Infection with unknown ANC - Duodenum † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Infection with unknown ANC - Foreign body (e.g., g † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Infection with unknown ANC - Heart (endocarditis) † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Infection with unknown ANC - Lung (pneumonia) † 1  0/2125 (0.00%)  2/2186 (0.09%)  3/1530 (0.20%) 
Infection with unknown ANC - Skin (cellulitis) † 1  0/2125 (0.00%)  10/2186 (0.46%)  3/1530 (0.20%) 
Infection with unknown ANC - Soft tissue NOS † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Infection with unknown ANC - Upper airway NOS † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Infection with unknown ANC - Urinary tract NOS † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Infection with unknown ANC - Wound † 1  0/2125 (0.00%)  7/2186 (0.32%)  1/1530 (0.07%) 
Infection-Other † 1  0/2125 (0.00%)  2/2186 (0.09%)  3/1530 (0.20%) 
Injury, poisoning and procedural complications       
Fracture † 1  0/2125 (0.00%)  11/2186 (0.50%)  10/1530 (0.65%) 
Intra-operative Injury-Other † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Intra-operative injury - Ovary † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Leak (including anastomotic), GI - Leak NOS † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Rash: dermatitis associated w/radiation † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Seroma † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Thrombosis/embolism (vascular access-related) † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Vessel injury-artery - Carotid † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Wound complication, non-infectious † 1  0/2125 (0.00%)  0/2186 (0.00%)  2/1530 (0.13%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase) † 1  0/2125 (0.00%)  5/2186 (0.23%)  1/1530 (0.07%) 
AST, SGOT † 1  0/2125 (0.00%)  4/2186 (0.18%)  2/1530 (0.13%) 
Alkaline phosphatase † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Bilirubin (hyperbilirubinemia) † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Creatinine † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Leukocytes (total WBC) † 1  0/2125 (0.00%)  3/2186 (0.14%)  2/1530 (0.13%) 
Lymphopenia † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Neutrophils/granulocytes (ANC/AGC) † 1  0/2125 (0.00%)  5/2186 (0.23%)  3/1530 (0.20%) 
Metabolism and nutrition disorders       
Acidosis (metabolic or respiratory) † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Anorexia † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Calcium, serum-low (hypocalcemia) † 1  0/2125 (0.00%)  2/2186 (0.09%)  1/1530 (0.07%) 
Dehydration † 1  0/2125 (0.00%)  8/2186 (0.37%)  4/1530 (0.26%) 
Glucose, serum-high (hyperglycemia) † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Glucose, serum-low (hypoglycemia) † 1  0/2125 (0.00%)  3/2186 (0.14%)  0/1530 (0.00%) 
Magnesium, serum-low (hypomagnesemia) † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Pancreatic endocrine: glucose intolerance † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Phosphate, serum-low (hypophosphatemia) † 1  0/2125 (0.00%)  2/2186 (0.09%)  2/1530 (0.13%) 
Potassium, serum-high (hyperkalemia) † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Potassium, serum-low (hypokalemia) † 1  0/2125 (0.00%)  3/2186 (0.14%)  1/1530 (0.07%) 
Sodium, serum-low (hyponatremia) † 1  0/2125 (0.00%)  3/2186 (0.14%)  0/1530 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis (non-septic) † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Muscle weakness, not d/t neuropathy - body/general † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Musculoskeletal/Soft Tissue-Other † 1  0/2125 (0.00%)  1/2186 (0.05%)  2/1530 (0.13%) 
Osteonecrosis (avascular necrosis) † 1  13/2125 (0.61%)  5/2186 (0.23%)  5/1530 (0.33%) 
Pain - Back † 1  0/2125 (0.00%)  1/2186 (0.05%)  3/1530 (0.20%) 
Pain - Bone † 1  0/2125 (0.00%)  2/2186 (0.09%)  2/1530 (0.13%) 
Pain - Chest wall † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Pain - Extremity-limb † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Pain - Joint † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Pain - Muscle † 1  0/2125 (0.00%)  3/2186 (0.14%)  0/1530 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Death - Disease progression NOS † 1  1/2125 (0.05%)  1/2186 (0.05%)  2/1530 (0.13%) 
Pain - Tumor pain † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Secondary Malignancy-poss rel to cancer Tx † 1  2/2125 (0.09%)  1/2186 (0.05%)  1/1530 (0.07%) 
Nervous system disorders       
Ataxia (incoordination) † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
CNS cerebrovascular ischemia † 1  0/2125 (0.00%)  4/2186 (0.18%)  4/1530 (0.26%) 
Cognitive disturbance † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Dizziness † 1  0/2125 (0.00%)  5/2186 (0.23%)  1/1530 (0.07%) 
Hemorrhage, CNS † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Neurology-Other † 1  0/2125 (0.00%)  1/2186 (0.05%)  2/1530 (0.13%) 
Neuropathy: CN VII Motor-face; Sensory-taste † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Neuropathy: motor † 1  0/2125 (0.00%)  1/2186 (0.05%)  2/1530 (0.13%) 
Neuropathy: sensory † 1  0/2125 (0.00%)  2/2186 (0.09%)  1/1530 (0.07%) 
Ocular/Visual-Other † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Pain - Head/headache † 1  0/2125 (0.00%)  7/2186 (0.32%)  0/1530 (0.00%) 
Somnolence/depressed level of consciousness † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Syncope (fainting) † 1  0/2125 (0.00%)  3/2186 (0.14%)  5/1530 (0.33%) 
Vasovagal episode † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Psychiatric disorders       
Confusion † 1  0/2125 (0.00%)  2/2186 (0.09%)  1/1530 (0.07%) 
Mood alteration - depression † 1  0/2125 (0.00%)  3/2186 (0.14%)  1/1530 (0.07%) 
Personality/behavioral † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Renal and urinary disorders       
Cystitis † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Glomerular filtration rate † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Hemorrhage, GU - Ureter † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Hemorrhage, GU - Urinary NOS † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Obstruction, GU - Ureter † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Pain - Bladder † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Pain - Kidney † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Proteinuria † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Renal failure † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Renal/Genitourinary-Other † 1  0/2125 (0.00%)  2/2186 (0.09%)  2/1530 (0.13%) 
Reproductive system and breast disorders       
Hemorrhage, GU - Uterus † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Sexual/Reproductive Function-Other † 1  1/2125 (0.05%)  0/2186 (0.00%)  4/1530 (0.26%) 
Respiratory, thoracic and mediastinal disorders       
Bronchospasm, wheezing † 1  0/2125 (0.00%)  2/2186 (0.09%)  1/1530 (0.07%) 
Cough † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Dyspnea (shortness of breath) † 1  0/2125 (0.00%)  10/2186 (0.46%)  9/1530 (0.59%) 
Hemorrhage, pulmonary/upper respiratory - Larynx † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Hypoxia † 1  0/2125 (0.00%)  2/2186 (0.09%)  3/1530 (0.20%) 
Pleural effusion (non-malignant) † 1  0/2125 (0.00%)  3/2186 (0.14%)  2/1530 (0.13%) 
Pneumonitis/pulmonary infiltrates † 1  0/2125 (0.00%)  3/2186 (0.14%)  1/1530 (0.07%) 
Pulmonary hypertension † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Pulmonary/Upper Respiratory-Other † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatology/Skin-Other † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Pruritus/itching † 1  0/2125 (0.00%)  1/2186 (0.05%)  1/1530 (0.07%) 
Rash/desquamation † 1  0/2125 (0.00%)  0/2186 (0.00%)  2/1530 (0.13%) 
Rash: erythema multiforme † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Rash: hand-foot skin reaction † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Urticaria (hives, welts, wheals) † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Vascular disorders       
Hematoma † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Hypertension † 1  0/2125 (0.00%)  1/2186 (0.05%)  0/1530 (0.00%) 
Hypotension † 1  0/2125 (0.00%)  2/2186 (0.09%)  0/1530 (0.00%) 
Phlebitis (including superficial thrombosis) † 1  0/2125 (0.00%)  0/2186 (0.00%)  1/1530 (0.07%) 
Thrombosis/thrombus/embolism † 1  0/2125 (0.00%)  9/2186 (0.41%)  10/1530 (0.65%) 
1
Term from vocabulary, CTCAE (3.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I Zoledronic Acid Arm II Clodronate Arm III Ibandronate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1854/2125 (87.25%)   1942/2186 (88.84%)   1366/1530 (89.28%) 
Blood and lymphatic system disorders       
Hemoglobin † 1  376/2125 (17.69%)  326/2186 (14.91%)  251/1530 (16.41%) 
Gastrointestinal disorders       
Constipation † 1  230/2125 (10.82%)  259/2186 (11.85%)  180/1530 (11.76%) 
Diarrhea † 1  288/2125 (13.55%)  447/2186 (20.45%)  223/1530 (14.58%) 
Heartburn/dyspepsia † 1  138/2125 (6.49%)  332/2186 (15.19%)  280/1530 (18.30%) 
Nausea † 1  454/2125 (21.36%)  555/2186 (25.39%)  307/1530 (20.07%) 
Pain - Abdomen NOS † 1  133/2125 (6.26%)  146/2186 (6.68%)  100/1530 (6.54%) 
Vomiting † 1  158/2125 (7.44%)  243/2186 (11.12%)  123/1530 (8.04%) 
General disorders       
Edema: limb † 1  243/2125 (11.44%)  212/2186 (9.70%)  163/1530 (10.65%) 
Fatigue (asthenia, lethargy, malaise) † 1  851/2125 (40.05%)  749/2186 (34.26%)  560/1530 (36.60%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L † 1  261/2125 (12.28%)  82/2186 (3.75%)  70/1530 (4.58%) 
Flu-like syndrome † 1  108/2125 (5.08%)  24/2186 (1.10%)  18/1530 (1.18%) 
Pain-Other † 1  185/2125 (8.71%)  149/2186 (6.82%)  122/1530 (7.97%) 
Rigors/chills † 1  109/2125 (5.13%)  27/2186 (1.24%)  18/1530 (1.18%) 
Injury, poisoning and procedural complications       
Rash: dermatitis associated w/radiation † 1  108/2125 (5.08%)  100/2186 (4.57%)  70/1530 (4.58%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase) † 1  290/2125 (13.65%)  540/2186 (24.70%)  170/1530 (11.11%) 
AST, SGOT † 1  308/2125 (14.49%)  581/2186 (26.58%)  190/1530 (12.42%) 
Alkaline phosphatase † 1  114/2125 (5.36%)  166/2186 (7.59%)  77/1530 (5.03%) 
Creatinine † 1  205/2125 (9.65%)  230/2186 (10.52%)  127/1530 (8.30%) 
Leukocytes (total WBC) † 1  366/2125 (17.22%)  370/2186 (16.93%)  205/1530 (13.40%) 
Lymphopenia † 1  209/2125 (9.84%)  181/2186 (8.28%)  125/1530 (8.17%) 
Metabolic/Laboratory-Other † 1  120/2125 (5.65%)  132/2186 (6.04%)  67/1530 (4.38%) 
Neutrophils/granulocytes (ANC/AGC) † 1  160/2125 (7.53%)  213/2186 (9.74%)  100/1530 (6.54%) 
Platelets † 1  118/2125 (5.55%)  140/2186 (6.40%)  51/1530 (3.33%) 
Weight gain † 1  124/2125 (5.84%)  137/2186 (6.27%)  81/1530 (5.29%) 
Metabolism and nutrition disorders       
Calcium, serum-high (hypercalcemia) † 1  109/2125 (5.13%)  97/2186 (4.44%)  61/1530 (3.99%) 
Calcium, serum-low (hypocalcemia) † 1  196/2125 (9.22%)  162/2186 (7.41%)  111/1530 (7.25%) 
Glucose, serum-high (hyperglycemia) † 1  484/2125 (22.78%)  429/2186 (19.62%)  283/1530 (18.50%) 
Glucose, serum-low (hypoglycemia) † 1  119/2125 (5.60%)  84/2186 (3.84%)  58/1530 (3.79%) 
Magnesium, serum-low (hypomagnesemia) † 1  120/2125 (5.65%)  88/2186 (4.03%)  82/1530 (5.36%) 
Phosphate, serum-low (hypophosphatemia) † 1  148/2125 (6.96%)  87/2186 (3.98%)  80/1530 (5.23%) 
Potassium, serum-low (hypokalemia) † 1  172/2125 (8.09%)  189/2186 (8.65%)  88/1530 (5.75%) 
Sodium, serum-low (hyponatremia) † 1  114/2125 (5.36%)  106/2186 (4.85%)  78/1530 (5.10%) 
Musculoskeletal and connective tissue disorders       
Arthritis (non-septic) † 1  206/2125 (9.69%)  197/2186 (9.01%)  143/1530 (9.35%) 
Pain - Back † 1  295/2125 (13.88%)  253/2186 (11.57%)  213/1530 (13.92%) 
Pain - Bone † 1  614/2125 (28.89%)  390/2186 (17.84%)  303/1530 (19.80%) 
Pain - Extremity-limb † 1  260/2125 (12.24%)  231/2186 (10.57%)  173/1530 (11.31%) 
Pain - Joint † 1  1071/2125 (50.40%)  968/2186 (44.28%)  756/1530 (49.41%) 
Pain - Muscle † 1  488/2125 (22.96%)  339/2186 (15.51%)  294/1530 (19.22%) 
Nervous system disorders       
Dizziness † 1  196/2125 (9.22%)  157/2186 (7.18%)  134/1530 (8.76%) 
Neuropathy: sensory † 1  464/2125 (21.84%)  447/2186 (20.45%)  311/1530 (20.33%) 
Pain - Head/headache † 1  310/2125 (14.59%)  270/2186 (12.35%)  205/1530 (13.40%) 
Psychiatric disorders       
Insomnia † 1  345/2125 (16.24%)  310/2186 (14.18%)  204/1530 (13.33%) 
Mood alteration - anxiety † 1  178/2125 (8.38%)  159/2186 (7.27%)  106/1530 (6.93%) 
Mood alteration - depression † 1  236/2125 (11.11%)  227/2186 (10.38%)  151/1530 (9.87%) 
Reproductive system and breast disorders       
Pain - Breast † 1  129/2125 (6.07%)  144/2186 (6.59%)  102/1530 (6.67%) 
Vaginal dryness † 1  128/2125 (6.02%)  137/2186 (6.27%)  90/1530 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  216/2125 (10.16%)  216/2186 (9.88%)  143/1530 (9.35%) 
Dyspnea (shortness of breath) † 1  185/2125 (8.71%)  133/2186 (6.08%)  116/1530 (7.58%) 
Skin and subcutaneous tissue disorders       
Hair loss/Alopecia (scalp or body) † 1  138/2125 (6.49%)  120/2186 (5.49%)  90/1530 (5.88%) 
Rash/desquamation † 1  306/2125 (14.40%)  307/2186 (14.04%)  194/1530 (12.68%) 
Sweating (diaphoresis) † 1  97/2125 (4.56%)  97/2186 (4.44%)  79/1530 (5.16%) 
Vascular disorders       
Hot flashes/flushes † 1  795/2125 (37.41%)  808/2186 (36.96%)  579/1530 (37.84%) 
Hypertension † 1  94/2125 (4.42%)  127/2186 (5.81%)  60/1530 (3.92%) 
1
Term from vocabulary, CTCAE (3.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SWOG statistician
Organization: SWOG Statistics & Data Management Center
Phone: 2066674263
EMail: jmiao@fredhutch.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00127205    
Other Study ID Numbers: CDR0000437061
S0307 ( Other Identifier: SWOG )
First Submitted: August 3, 2005
First Posted: August 5, 2005
Results First Submitted: June 20, 2019
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2020