Trial Outcomes & Findings for A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment (NCT NCT00551174)
NCT ID: NCT00551174
Last Updated: 2011-07-22
Results Overview
Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
781 participants
Primary outcome timeframe
Baseline,12, 24 and 36 months
Results posted on
2011-07-22
Participant Flow
Study enrollment was to occur at centers that had participated in BM16550 (NCT00048074) in North America, Mexico, Europe, Australia, and South Africa.
Postmenopausal osteoporosis. Patients having completed study BM16550 (NCT00048074) and who had complied with the intravenous (IV) regimen during the second year of study BM16550 (NCT00048074) for 75% or more.
Participant milestones
| Measure |
2 mg Ibandronate q2mo
2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
|
3 mg Ibandronate q3mo
3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
|
|---|---|---|
|
Overall Study
STARTED
|
381
|
400
|
|
Overall Study
COMPLETED
|
362
|
394
|
|
Overall Study
NOT COMPLETED
|
19
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Baseline characteristics by cohort
| Measure |
2 mg Ibandronate q2mo
n=381 Participants
2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
|
3 mg Ibandronate q3mo
n=400 Participants
3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
|
Total
n=781 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
68.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
68.0 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
381 Participants
n=5 Participants
|
400 Participants
n=7 Participants
|
781 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
363 participants
n=5 Participants
|
388 participants
n=7 Participants
|
751 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
BMI
|
25.63 kg/m*2
STANDARD_DEVIATION 4.295 • n=5 Participants
|
25.89 kg/m*2
STANDARD_DEVIATION 4.394 • n=7 Participants
|
25.76 kg/m*2
STANDARD_DEVIATION 4.3460 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline,12, 24 and 36 monthsPopulation: ITT population: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 383, 2 mg group = 348; Month 24: 3 mg group = 374, 2 mg group = 332; Month 36: 3 mg group = 349, 2 mg group = 314.
Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Outcome measures
| Measure |
2 mg Ibandronate q2mo
n=362 Participants
2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
|
3 mg Ibandronate q3mo
n=394 Participants
3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
|
|---|---|---|
|
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
Baseline
|
0.7969 Percent change
Standard Deviation 0.0764
|
0.7861 Percent change
Standard Deviation 0.0824
|
|
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
Percent Change from Baseline at Month 12
|
0.8378 Percent change
Standard Deviation 3.1920
|
0.8845 Percent change
Standard Deviation 3.6386
|
|
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
Percent Change from Baseline at Month 24
|
1.6785 Percent change
Standard Deviation 3.6494
|
1.5742 Percent change
Standard Deviation 4.0665
|
|
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
Percent Change from Baseline at Month 36
|
1.9813 Percent change
Standard Deviation 4.6619
|
2.0559 Percent change
Standard Deviation 4.4747
|
SECONDARY outcome
Timeframe: Baseline,12, 24 and 36 monthsPopulation: ITT populations: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 381, 2 mg group = 347; Month 24: 3 mg group = 371, 2 mg group = 330; Month 36: 3 mg group = 349, 2 mg group = 314.
Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Outcome measures
| Measure |
2 mg Ibandronate q2mo
n=362 Participants
2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
|
3 mg Ibandronate q3mo
n=394 Participants
3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
|
|---|---|---|
|
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months
Baseline
|
0.7651 Percent change
Standard Deviation 0.1035
|
0.7665 Percent change
Standard Deviation 0.0954
|
|
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months
Percent Change from Baseline at Month 12
|
0.4487 Percent change
Standard Deviation 2.5604
|
0.1258 Percent change
Standard Deviation 3.0450
|
|
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months
Percent Change from Baseline Month 24
|
0.0483 Percent change
Standard Deviation 3.0148
|
-0.049 Percent change
Standard Deviation 3.0440
|
|
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months
Percent Change from Baseline at Month 36
|
-0.1546 Percent change
Standard Deviation 3.3604
|
-0.2619 Percent change
Standard Deviation 4.0099
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)Population: Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 87, 2 mg group: 92; Month 12: 3 mg group = 92, 2 mg group = 92; Month 24: 3 mg group = 83, 2 mg group = 85; Month 36: 3 mg group = 75, 2 mg group = 76.
Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Outcome measures
| Measure |
2 mg Ibandronate q2mo
n=344 Participants
2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
|
3 mg Ibandronate q3mo
n=363 Participants
3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
|
|---|---|---|
|
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
Baseline
|
0.232 Percent change
Standard Deviation 0.1327
|
0.264 Percent change
Standard Deviation 0.1497
|
|
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
Percent Change from Baseline at Month 6
|
17.562 Percent change
Standard Deviation 64.2113
|
20.091 Percent change
Standard Deviation 65.6960
|
|
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
Percent Change from Baseline at Month 36
|
41.478 Percent change
Standard Deviation 67.1965
|
58.478 Percent change
Standard Deviation 160.1702
|
|
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
Percent Change from Baseline at Month 12
|
35.934 Percent change
Standard Deviation 82.8825
|
34.009 Percent change
Standard Deviation 103.5972
|
|
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
Percent Change from Baseline at Month 24
|
42.237 Percent change
Standard Deviation 73.7395
|
47.442 Percent change
Standard Deviation 121.5415
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 89, 2 mg group: 93.
Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.
Outcome measures
| Measure |
2 mg Ibandronate q2mo
n=344 Participants
2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
|
3 mg Ibandronate q3mo
n=363 Participants
3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
|
|---|---|---|
|
Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months
Baseline
|
0.232 Percent change
Standard Deviation 0.1327
|
0.264 Percent change
Standard Deviation 0.1497
|
|
Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months
Percent Change from Baseline at Month 6
|
-78.024 Percent change
Standard Deviation 18.2619
|
-81.617 Percent change
Standard Deviation 22.0440
|
Adverse Events
2 mg Ibandronate q2mo
Serious events: 90 serious events
Other events: 265 other events
Deaths: 0 deaths
3 mg Ibandronate q3mo
Serious events: 84 serious events
Other events: 285 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 mg Ibandronate q2mo
n=381 participants at risk
2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
|
3 mg Ibandronate q3mo
n=400 participants at risk
3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.26%
1/381
|
1.2%
5/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.52%
2/381
|
0.00%
0/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.52%
2/381
|
0.00%
0/400
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.79%
3/381
|
0.50%
2/400
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.26%
1/381
|
0.75%
3/400
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.26%
1/381
|
0.50%
2/400
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.26%
1/381
|
0.50%
2/400
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.52%
2/381
|
0.00%
0/400
|
|
Infections and infestations
Pneumonia
|
1.3%
5/381
|
1.0%
4/400
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.79%
3/381
|
1.2%
5/400
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.52%
2/381
|
0.25%
1/400
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.26%
1/381
|
0.50%
2/400
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/381
|
0.50%
2/400
|
|
Cardiac disorders
Myocardial Infarction
|
1.6%
6/381
|
0.00%
0/400
|
|
Cardiac disorders
Atrial Fibrillation
|
0.79%
3/381
|
0.00%
0/400
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.52%
2/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.26%
1/381
|
0.50%
2/400
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.26%
1/381
|
0.75%
3/400
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/381
|
0.75%
3/400
|
|
Nervous system disorders
Sciatica
|
0.52%
2/381
|
0.00%
0/400
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.79%
3/381
|
0.00%
0/400
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.52%
2/381
|
0.00%
0/400
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/381
|
0.50%
2/400
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/381
|
0.50%
2/400
|
|
Ear and labyrinth disorders
Vertigo
|
0.79%
3/381
|
0.00%
0/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.26%
1/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.26%
1/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.26%
1/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
|
0.26%
1/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.00%
0/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.26%
1/381
|
0.00%
0/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
|
0.00%
0/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Uterine Neoplasm
|
0.00%
0/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.00%
0/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.26%
1/381
|
0.00%
0/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.26%
1/381
|
0.00%
0/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Recurrent
|
0.26%
1/381
|
0.00%
0/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
|
0.00%
0/381
|
0.25%
1/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.26%
1/381
|
0.00%
0/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer Metastatic
|
0.26%
1/381
|
0.00%
0/400
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.00%
0/381
|
0.25%
1/400
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.26%
1/381
|
0.25%
1/400
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.26%
1/381
|
0.25%
1/400
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.26%
1/381
|
0.00%
0/400
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/381
|
0.25%
1/400
|
|
Injury, poisoning and procedural complications
Contusion
|
0.26%
1/381
|
0.00%
0/400
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.26%
1/381
|
0.00%
0/400
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/381
|
0.25%
1/400
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/381
|
0.25%
1/400
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/381
|
0.25%
1/400
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.26%
1/381
|
0.00%
0/400
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/381
|
0.25%
1/400
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.26%
1/381
|
0.00%
0/400
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/381
|
0.25%
1/400
|
|
Infections and infestations
Appendicitis
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Borrelia Infection
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Breast Abscess
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Bronchopneumonia
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/381
|
0.25%
1/400
|
|
Infections and infestations
Eye Infection
|
0.00%
0/381
|
0.25%
1/400
|
|
Infections and infestations
Gallbladder Empyema
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Gastrointestinal Infection
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/381
|
0.25%
1/400
|
|
Infections and infestations
Herpes Zoster Ophthalmic
|
0.00%
0/381
|
0.25%
1/400
|
|
Infections and infestations
Infective Tenosynovitis
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/381
|
0.25%
1/400
|
|
Infections and infestations
Osteomyelitis
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Pyelonephritis Acute
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Typhoid Fever
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Urinary Tract Infection
|
0.26%
1/381
|
0.00%
0/400
|
|
Infections and infestations
Urosepsis
|
0.00%
0/381
|
0.25%
1/400
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
1/381
|
0.00%
0/400
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/381
|
0.25%
1/400
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/381
|
0.25%
1/400
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.26%
1/381
|
0.00%
0/400
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.26%
1/381
|
0.00%
0/400
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/381
|
0.25%
1/400
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.26%
1/381
|
0.00%
0/400
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/381
|
0.25%
1/400
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/381
|
0.25%
1/400
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.26%
1/381
|
0.00%
0/400
|
|
Cardiac disorders
Angina Pectoris
|
0.26%
1/381
|
0.25%
1/400
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/381
|
0.25%
1/400
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/381
|
0.25%
1/400
|
|
Cardiac disorders
Cardiac Discomfort
|
0.26%
1/381
|
0.00%
0/400
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/381
|
0.25%
1/400
|
|
Cardiac disorders
Coronary Artery Disease
|
0.26%
1/381
|
0.00%
0/400
|
|
Cardiac disorders
Left Ventricular Failure
|
0.26%
1/381
|
0.00%
0/400
|
|
Cardiac disorders
Wolff-Parkinson-White Syndrome
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.26%
1/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Femoral Hernia
|
0.00%
0/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Gatritis
|
0.00%
0/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/381
|
0.25%
1/400
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Pancreatitis Necrotising
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Papilla of Vater Stenosis
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.26%
1/381
|
0.00%
0/400
|
|
Gastrointestinal disorders
Subileus
|
0.26%
1/381
|
0.00%
0/400
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.26%
1/381
|
0.00%
0/400
|
|
Nervous system disorders
Cauda Equina Syndrome
|
0.26%
1/381
|
0.00%
0/400
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/381
|
0.25%
1/400
|
|
Nervous system disorders
Parkinson's Disease
|
0.26%
1/381
|
0.00%
0/400
|
|
Nervous system disorders
Presyncope
|
0.00%
0/381
|
0.25%
1/400
|
|
Nervous system disorders
Syncope
|
0.00%
0/381
|
0.25%
1/400
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.26%
1/381
|
0.25%
1/400
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.26%
1/381
|
0.00%
0/400
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.26%
1/381
|
0.00%
0/400
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/381
|
0.00%
0/400
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/381
|
0.25%
1/400
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/381
|
0.25%
1/400
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.26%
1/381
|
0.00%
0/400
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/381
|
0.25%
1/400
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.26%
1/381
|
0.00%
0/400
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thrombosis
|
0.26%
1/381
|
0.00%
0/400
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/381
|
0.25%
1/400
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.26%
1/381
|
0.25%
1/400
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.26%
1/381
|
0.00%
0/400
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.26%
1/381
|
0.00%
0/400
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.00%
0/381
|
0.25%
1/400
|
|
General disorders
Chest Pain
|
0.26%
1/381
|
0.25%
1/400
|
|
General disorders
Fatigue
|
0.26%
1/381
|
0.00%
0/400
|
|
General disorders
Malaise
|
0.00%
0/381
|
0.25%
1/400
|
|
General disorders
Multi-Organ Failure
|
0.26%
1/381
|
0.00%
0/400
|
|
General disorders
Non-Cardiac Chest Pain
|
0.26%
1/381
|
0.00%
0/400
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.26%
1/381
|
0.25%
1/400
|
|
Vascular disorders
Hypertension
|
0.26%
1/381
|
0.00%
0/400
|
|
Vascular disorders
Hypertensive Crisis
|
0.26%
1/381
|
0.00%
0/400
|
|
Vascular disorders
Hypotension
|
0.00%
0/381
|
0.25%
1/400
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.26%
1/381
|
0.25%
1/400
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
1/381
|
0.25%
1/400
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/381
|
0.25%
1/400
|
|
Renal and urinary disorders
Hydronephrosis
|
0.26%
1/381
|
0.00%
0/400
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.26%
1/381
|
0.00%
0/400
|
|
Eye disorders
Cataract
|
0.26%
1/381
|
0.00%
0/400
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/381
|
0.25%
1/400
|
|
Eye disorders
Dacryostenosis Acquired
|
0.26%
1/381
|
0.00%
0/400
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.26%
1/381
|
0.00%
0/400
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.26%
1/381
|
0.00%
0/400
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/381
|
0.25%
1/400
|
|
Endocrine disorders
Goitre
|
0.00%
0/381
|
0.25%
1/400
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/381
|
0.25%
1/400
|
|
Psychiatric disorders
Depression
|
0.00%
0/381
|
0.25%
1/400
|
Other adverse events
| Measure |
2 mg Ibandronate q2mo
n=381 participants at risk
2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
|
3 mg Ibandronate q3mo
n=400 participants at risk
3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
20.7%
79/381
|
16.8%
67/400
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.8%
64/381
|
17.8%
71/400
|
|
Vascular disorders
Hypertension
|
13.9%
53/381
|
14.8%
59/400
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
57/381
|
11.8%
47/400
|
|
Infections and infestations
Influenza
|
11.0%
42/381
|
11.0%
44/400
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.4%
36/381
|
7.8%
31/400
|
|
Infections and infestations
Bronchitis
|
8.7%
33/381
|
6.8%
27/400
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.6%
29/381
|
6.8%
27/400
|
|
Infections and infestations
Urinary Tract Infection
|
8.1%
31/381
|
5.8%
23/400
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
8.1%
31/381
|
5.2%
21/400
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.6%
25/381
|
6.8%
27/400
|
|
Infections and infestations
Pneumonia
|
5.5%
21/381
|
6.0%
24/400
|
|
Infections and infestations
Cystitis
|
6.3%
24/381
|
4.5%
18/400
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
21/381
|
5.2%
21/400
|
|
Eye disorders
Cataract
|
5.0%
19/381
|
5.2%
21/400
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.2%
20/381
|
5.0%
20/400
|
|
Psychiatric disorders
Depression
|
3.9%
15/381
|
5.2%
21/400
|
|
Nervous system disorders
Dizziness
|
5.5%
21/381
|
2.0%
8/400
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.2%
20/381
|
2.0%
8/400
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER