A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00551174
Collaborator
(none)
781
39
2
49
20
0.4
Study Details
Study Description
Brief Summary
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
781 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550
Study Start Date
:
Oct 1, 2004
Actual Primary Completion Date
:
Nov 1, 2008
Actual Study Completion Date
:
Nov 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: ibandronate [Bonviva/Boniva]
3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
|
| Active Comparator: 2
|
Drug: ibandronate [Bonviva/Boniva]
2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
|
Outcome Measures
Primary Outcome Measures
- Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months [Baseline,12, 24 and 36 months]
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.
Secondary Outcome Measures
- Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months [Baseline,12, 24 and 36 months]
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.
- 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, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)]
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.
- Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months [Baseline, 6 months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
-
Ambulatory
Exclusion Criteria:
-
Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study
-
Malignant disease diagnosed since inclusion into previous study
-
Treatment with drugs affecting bone metabolism since inclusion into previous study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gainesville | Georgia | United States | 30501 | |
| 2 | St Louis | Missouri | United States | 63110 | |
| 3 | Omaha | Nebraska | United States | 68131 | |
| 4 | Bismarck | North Dakota | United States | 58501 | |
| 5 | Fargo | North Dakota | United States | 58103 | |
| 6 | Madison | Wisconsin | United States | 53792 | |
| 7 | St. Leonards | Australia | 2139 | ||
| 8 | Sydney | Australia | 3129 | ||
| 9 | Bruxelles | Belgium | 1180 | ||
| 10 | Liege | Belgium | 4020 | ||
| 11 | Plzen | Czech Republic | 305 99 | ||
| 12 | Praha | Czech Republic | 128 00 | ||
| 13 | Aalborg | Denmark | 9000 | ||
| 14 | Ballerup | Denmark | 2750 | ||
| 15 | København | Denmark | 1399 | ||
| 16 | Vejle | Denmark | 7100 | ||
| 17 | Århus | Denmark | 8000 | ||
| 18 | Lyon | France | 69000 | ||
| 19 | Orleans | France | 45032 | ||
| 20 | Berlin | Germany | 12200 | ||
| 21 | Essen | Germany | 45276 | ||
| 22 | Hamburg | Germany | 20354 | ||
| 23 | Budapest | Hungary | 1036 | ||
| 24 | Arenzano | Italy | 16011 | ||
| 25 | Siena | Italy | 53100 | ||
| 26 | Valeggio Sul Mincio | Italy | 37067 | ||
| 27 | Mexico City | Mexico | 11000 | ||
| 28 | Monterrey | Mexico | 64460 | ||
| 29 | Haugesund | Norway | 5507 | ||
| 30 | Oslo | Norway | 0176 | ||
| 31 | Stavanger | Norway | 4010 | ||
| 32 | Grudziadz | Poland | 86-300 | ||
| 33 | Krakow | Poland | 30-510 | ||
| 34 | Krakow | Poland | 31-501 | ||
| 35 | Cape Town | South Africa | 7500 | ||
| 36 | Pretoria | South Africa | |||
| 37 | Sommerset West | South Africa | 7129 | ||
| 38 | Madrid | Spain | 28046 | ||
| 39 | Aberdeen | United Kingdom | AB25 2ZD |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00551174
Other Study ID Numbers:
- MA17904
First Posted:
Oct 30, 2007
Last Update Posted:
Jul 22, 2011
Last Verified:
Jul 1, 2011
Study Results
Participant Flow
| Recruitment Details | Study enrollment was to occur at centers that had participated in BM16550 (NCT00048074) in North America, Mexico, Europe, Australia, and South Africa. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo |
|---|---|---|
| Arm/Group Description | 2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years | 3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years |
| Period Title: Overall Study | ||
| STARTED | 381 | 400 |
| COMPLETED | 362 | 394 |
| NOT COMPLETED | 19 | 6 |
Baseline Characteristics
| Arm/Group Title | 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo | Total |
|---|---|---|---|
| Arm/Group Description | 2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years | 3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years | Total of all reporting groups |
| Overall Participants | 381 | 400 | 781 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
68.2
(6.1)
|
67.9
(6.0)
|
68.0
(6.0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
381
100%
|
400
100%
|
781
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Caucasian/White |
363
95.3%
|
388
97%
|
751
96.2%
|
| Black |
0
0%
|
0
0%
|
0
0%
|
| Oriental |
0
0%
|
0
0%
|
0
0%
|
| Hispanic |
17
4.5%
|
11
2.8%
|
28
3.6%
|
| Other |
1
0.3%
|
1
0.3%
|
2
0.3%
|
| BMI (kg/m*2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m*2] |
25.63
(4.295)
|
25.89
(4.394)
|
25.76
(4.3460)
|
Outcome Measures
| Title | Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months |
|---|---|
| Description | 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. |
| Time Frame | Baseline,12, 24 and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo |
|---|---|---|
| Arm/Group Description | 2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years | 3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years |
| Measure Participants | 362 | 394 |
| Baseline |
0.7969
(0.0764)
|
0.7861
(0.0824)
|
| Percent Change from Baseline at Month 12 |
0.8378
(3.1920)
|
0.8845
(3.6386)
|
| Percent Change from Baseline at Month 24 |
1.6785
(3.6494)
|
1.5742
(4.0665)
|
| Percent Change from Baseline at Month 36 |
1.9813
(4.6619)
|
2.0559
(4.4747)
|
| Title | Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months |
|---|---|
| Description | 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. |
| Time Frame | Baseline,12, 24 and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo |
|---|---|---|
| Arm/Group Description | 2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years | 3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years |
| Measure Participants | 362 | 394 |
| Baseline |
0.7651
(0.1035)
|
0.7665
(0.0954)
|
| Percent Change from Baseline at Month 12 |
0.4487
(2.5604)
|
0.1258
(3.0450)
|
| Percent Change from Baseline Month 24 |
0.0483
(3.0148)
|
-0.049
(3.0440)
|
| Percent Change from Baseline at Month 36 |
-0.1546
(3.3604)
|
-0.2619
(4.0099)
|
| Title | Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo |
|---|---|---|
| Arm/Group Description | 2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years | 3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years |
| Measure Participants | 344 | 363 |
| Baseline |
0.232
(0.1327)
|
0.264
(0.1497)
|
| Percent Change from Baseline at Month 6 |
17.562
(64.2113)
|
20.091
(65.6960)
|
| Percent Change from Baseline at Month 12 |
35.934
(82.8825)
|
34.009
(103.5972)
|
| Percent Change from Baseline at Month 24 |
42.237
(73.7395)
|
47.442
(121.5415)
|
| Percent Change from Baseline at Month 36 |
41.478
(67.1965)
|
58.478
(160.1702)
|
| Title | Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo |
|---|---|---|
| Arm/Group Description | 2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years | 3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years |
| Measure Participants | 344 | 363 |
| Baseline |
0.232
(0.1327)
|
0.264
(0.1497)
|
| Percent Change from Baseline at Month 6 |
-78.024
(18.2619)
|
-81.617
(22.0440)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo | ||
| Arm/Group Description | 2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years | 3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years | ||
All Cause Mortality |
||||
| 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 90/381 (23.6%) | 84/400 (21%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/381 (0%) | 1/400 (0.3%) | ||
| Cardiac disorders | ||||
| Myocardial Infarction | 6/381 (1.6%) | 0/400 (0%) | ||
| Atrial Fibrillation | 3/381 (0.8%) | 0/400 (0%) | ||
| Myocardial Ischaemia | 2/381 (0.5%) | 1/400 (0.3%) | ||
| Angina Pectoris | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Atrial Flutter | 0/381 (0%) | 1/400 (0.3%) | ||
| Atrioventricular Block Complete | 0/381 (0%) | 1/400 (0.3%) | ||
| Cardiac Discomfort | 1/381 (0.3%) | 0/400 (0%) | ||
| Cardio-Respiratory Arrest | 0/381 (0%) | 1/400 (0.3%) | ||
| Coronary Artery Disease | 1/381 (0.3%) | 0/400 (0%) | ||
| Left Ventricular Failure | 1/381 (0.3%) | 0/400 (0%) | ||
| Wolff-Parkinson-White Syndrome | 1/381 (0.3%) | 0/400 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 3/381 (0.8%) | 0/400 (0%) | ||
| Endocrine disorders | ||||
| Goitre | 0/381 (0%) | 1/400 (0.3%) | ||
| Eye disorders | ||||
| Cataract | 1/381 (0.3%) | 0/400 (0%) | ||
| Conjunctivitis | 0/381 (0%) | 1/400 (0.3%) | ||
| Dacryostenosis Acquired | 1/381 (0.3%) | 0/400 (0%) | ||
| Gastrointestinal disorders | ||||
| Hiatus Hernia | 1/381 (0.3%) | 2/400 (0.5%) | ||
| Duodenal Ulcer | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Abdominal Pain | 1/381 (0.3%) | 0/400 (0%) | ||
| Abdominal Pain Lower | 0/381 (0%) | 1/400 (0.3%) | ||
| Colitis Ulcerative | 1/381 (0.3%) | 0/400 (0%) | ||
| Constipation | 0/381 (0%) | 1/400 (0.3%) | ||
| Diverticulum Intestinal | 0/381 (0%) | 1/400 (0.3%) | ||
| Duodenal Ulcer Haemorrhage | 0/381 (0%) | 1/400 (0.3%) | ||
| Dysphagia | 0/381 (0%) | 1/400 (0.3%) | ||
| Femoral Hernia | 0/381 (0%) | 1/400 (0.3%) | ||
| Gatritis | 0/381 (0%) | 1/400 (0.3%) | ||
| Gastrointestinal Disorder | 1/381 (0.3%) | 0/400 (0%) | ||
| Gastrointestinal Haemorrhage | 1/381 (0.3%) | 0/400 (0%) | ||
| Inguinal Hernia | 0/381 (0%) | 1/400 (0.3%) | ||
| Inguinal Hernia, Obstructive | 1/381 (0.3%) | 0/400 (0%) | ||
| Pancreatitis Necrotising | 1/381 (0.3%) | 0/400 (0%) | ||
| Papilla of Vater Stenosis | 1/381 (0.3%) | 0/400 (0%) | ||
| Peptic Ulcer Haemorrhage | 1/381 (0.3%) | 0/400 (0%) | ||
| Subileus | 1/381 (0.3%) | 0/400 (0%) | ||
| General disorders | ||||
| Chest Pain | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Fatigue | 1/381 (0.3%) | 0/400 (0%) | ||
| Malaise | 0/381 (0%) | 1/400 (0.3%) | ||
| Multi-Organ Failure | 1/381 (0.3%) | 0/400 (0%) | ||
| Non-Cardiac Chest Pain | 1/381 (0.3%) | 0/400 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/381 (0%) | 2/400 (0.5%) | ||
| Bile Duct Stone | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Cholelithiasis | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Cholangitis | 0/381 (0%) | 1/400 (0.3%) | ||
| Infections and infestations | ||||
| Pneumonia | 5/381 (1.3%) | 4/400 (1%) | ||
| Appendicitis | 1/381 (0.3%) | 0/400 (0%) | ||
| Borrelia Infection | 1/381 (0.3%) | 0/400 (0%) | ||
| Breast Abscess | 1/381 (0.3%) | 0/400 (0%) | ||
| Bronchopneumonia | 1/381 (0.3%) | 0/400 (0%) | ||
| Escherichia Bacteraemia | 0/381 (0%) | 1/400 (0.3%) | ||
| Eye Infection | 0/381 (0%) | 1/400 (0.3%) | ||
| Gallbladder Empyema | 1/381 (0.3%) | 0/400 (0%) | ||
| Gastrointestinal Infection | 1/381 (0.3%) | 0/400 (0%) | ||
| Herpes Zoster | 0/381 (0%) | 1/400 (0.3%) | ||
| Herpes Zoster Ophthalmic | 0/381 (0%) | 1/400 (0.3%) | ||
| Infective Tenosynovitis | 1/381 (0.3%) | 0/400 (0%) | ||
| Lower Respiratory Tract Infection | 0/381 (0%) | 1/400 (0.3%) | ||
| Osteomyelitis | 1/381 (0.3%) | 0/400 (0%) | ||
| Pulmonary Tuberculosis | 1/381 (0.3%) | 0/400 (0%) | ||
| Pyelonephritis Acute | 1/381 (0.3%) | 0/400 (0%) | ||
| Typhoid Fever | 1/381 (0.3%) | 0/400 (0%) | ||
| Urinary Tract Infection | 1/381 (0.3%) | 0/400 (0%) | ||
| Urosepsis | 0/381 (0%) | 1/400 (0.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Radius Fracture | 3/381 (0.8%) | 2/400 (0.5%) | ||
| Femur Fracture | 1/381 (0.3%) | 3/400 (0.8%) | ||
| Femoral Neck Fracture | 1/381 (0.3%) | 2/400 (0.5%) | ||
| Ulna Fracture | 1/381 (0.3%) | 2/400 (0.5%) | ||
| Lumbar Vertebral Fracture | 2/381 (0.5%) | 0/400 (0%) | ||
| Humerus Fracture | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Lower Limb Fracture | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Ankle Fracture | 1/381 (0.3%) | 0/400 (0%) | ||
| Clavicle Fracture | 0/381 (0%) | 1/400 (0.3%) | ||
| Contusion | 1/381 (0.3%) | 0/400 (0%) | ||
| Foot Fracture | 1/381 (0.3%) | 0/400 (0%) | ||
| Hand Fracture | 0/381 (0%) | 1/400 (0.3%) | ||
| Joint Dislocation | 0/381 (0%) | 1/400 (0.3%) | ||
| Pelvic Fracture | 0/381 (0%) | 1/400 (0.3%) | ||
| Rib Fracture | 1/381 (0.3%) | 0/400 (0%) | ||
| Spinal Compression Fracture | 0/381 (0%) | 1/400 (0.3%) | ||
| Tendon Rupture | 1/381 (0.3%) | 0/400 (0%) | ||
| Wrist Fracture | 0/381 (0%) | 1/400 (0.3%) | ||
| Investigations | ||||
| Platelet Count Decreased | 0/381 (0%) | 1/400 (0.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 3/381 (0.8%) | 5/400 (1.3%) | ||
| Back Pain | 2/381 (0.5%) | 1/400 (0.3%) | ||
| Foot Deformity | 1/381 (0.3%) | 2/400 (0.5%) | ||
| Intervertebral Disc Protrusion | 0/381 (0%) | 2/400 (0.5%) | ||
| Arthralgia | 1/381 (0.3%) | 0/400 (0%) | ||
| Arthritis | 0/381 (0%) | 1/400 (0.3%) | ||
| Bursitis | 0/381 (0%) | 1/400 (0.3%) | ||
| Intervertebral Disc Disorder | 1/381 (0.3%) | 0/400 (0%) | ||
| Joint Effusion | 1/381 (0.3%) | 0/400 (0%) | ||
| Lumbar Spinal Stenosis | 0/381 (0%) | 1/400 (0.3%) | ||
| Muscle Haemorrhage | 1/381 (0.3%) | 0/400 (0%) | ||
| Musculoskeletal Chest Pain | 0/381 (0%) | 1/400 (0.3%) | ||
| Musculoskeletal Pain | 0/381 (0%) | 1/400 (0.3%) | ||
| Myalgia | 1/381 (0.3%) | 0/400 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast Cancer | 1/381 (0.3%) | 5/400 (1.3%) | ||
| Basal Cell Carcinoma | 2/381 (0.5%) | 0/400 (0%) | ||
| Colon Cancer | 2/381 (0.5%) | 0/400 (0%) | ||
| Lung Neoplasm Malignant | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Ovarian Cancer | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Rectal Cancer | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Thyroid Neoplasm | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Acute Myeloid Leukaemia | 0/381 (0%) | 1/400 (0.3%) | ||
| Adenocarcinoma Pancreas | 1/381 (0.3%) | 0/400 (0%) | ||
| B-Cell Lymphoma | 0/381 (0%) | 1/400 (0.3%) | ||
| Benign Uterine Neoplasm | 0/381 (0%) | 1/400 (0.3%) | ||
| Bile Duct Cancer | 0/381 (0%) | 1/400 (0.3%) | ||
| Endometrial Cancer | 1/381 (0.3%) | 0/400 (0%) | ||
| Lipoma | 1/381 (0.3%) | 0/400 (0%) | ||
| Lung Adenocarcinoma | 0/381 (0%) | 1/400 (0.3%) | ||
| Myelodysplastic Syndrome | 0/381 (0%) | 1/400 (0.3%) | ||
| Rectal Cancer Recurrent | 1/381 (0.3%) | 0/400 (0%) | ||
| Small Cell Lung Cancer Stage Unspecified | 0/381 (0%) | 1/400 (0.3%) | ||
| Squamous Cell Carcinoma of Skin | 1/381 (0.3%) | 0/400 (0%) | ||
| Thyroid Cancer Metastatic | 1/381 (0.3%) | 0/400 (0%) | ||
| Uterine Cancer | 0/381 (0%) | 1/400 (0.3%) | ||
| Nervous system disorders | ||||
| Transient Ischaemic Attack | 1/381 (0.3%) | 3/400 (0.8%) | ||
| Cerebrovascular Accident | 0/381 (0%) | 3/400 (0.8%) | ||
| Sciatica | 2/381 (0.5%) | 0/400 (0%) | ||
| Carotid Artery Stenosis | 1/381 (0.3%) | 0/400 (0%) | ||
| Cauda Equina Syndrome | 1/381 (0.3%) | 0/400 (0%) | ||
| Cerebral Infarction | 0/381 (0%) | 1/400 (0.3%) | ||
| Parkinson's Disease | 1/381 (0.3%) | 0/400 (0%) | ||
| Presyncope | 0/381 (0%) | 1/400 (0.3%) | ||
| Syncope | 0/381 (0%) | 1/400 (0.3%) | ||
| Psychiatric disorders | ||||
| Depression | 0/381 (0%) | 1/400 (0.3%) | ||
| Renal and urinary disorders | ||||
| Nephrolithiasis | 0/381 (0%) | 2/400 (0.5%) | ||
| Hydronephrosis | 1/381 (0.3%) | 0/400 (0%) | ||
| Urethral Stenosis | 1/381 (0.3%) | 0/400 (0%) | ||
| Reproductive system and breast disorders | ||||
| Uterine Polyp | 2/381 (0.5%) | 0/400 (0%) | ||
| Vaginal Haemorrhage | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Ovarian Cyst | 1/381 (0.3%) | 0/400 (0%) | ||
| Uterine Prolapse | 1/381 (0.3%) | 0/400 (0%) | ||
| Vaginal Prolapse | 0/381 (0%) | 1/400 (0.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic Obstructive Pulmonary Disease | 3/381 (0.8%) | 0/400 (0%) | ||
| Pulmonary Embolism | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Acute Pulmonary Oedema | 1/381 (0.3%) | 0/400 (0%) | ||
| Bronchitis Chronic | 1/381 (0.3%) | 0/400 (0%) | ||
| Dyspnoea | 1/381 (0.3%) | 0/400 (0%) | ||
| Epistaxis | 0/381 (0%) | 1/400 (0.3%) | ||
| Pleurisy | 0/381 (0%) | 1/400 (0.3%) | ||
| Pneumothorax | 1/381 (0.3%) | 0/400 (0%) | ||
| Pulmonary Fibrosis | 0/381 (0%) | 1/400 (0.3%) | ||
| Pulmonary Oedema | 1/381 (0.3%) | 0/400 (0%) | ||
| Pulmonary Thrombosis | 1/381 (0.3%) | 0/400 (0%) | ||
| Respiratory Failure | 0/381 (0%) | 1/400 (0.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash Papular | 1/381 (0.3%) | 0/400 (0%) | ||
| Urticaria | 1/381 (0.3%) | 0/400 (0%) | ||
| Vascular disorders | ||||
| Deep Vein Thrombosis | 1/381 (0.3%) | 1/400 (0.3%) | ||
| Hypertension | 1/381 (0.3%) | 0/400 (0%) | ||
| Hypertensive Crisis | 1/381 (0.3%) | 0/400 (0%) | ||
| Hypotension | 0/381 (0%) | 1/400 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| 2 mg Ibandronate q2mo | 3 mg Ibandronate q3mo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 265/381 (69.6%) | 285/400 (71.3%) | ||
| Eye disorders | ||||
| Cataract | 19/381 (5%) | 21/400 (5.3%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 21/381 (5.5%) | 21/400 (5.3%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 79/381 (20.7%) | 67/400 (16.8%) | ||
| Influenza | 42/381 (11%) | 44/400 (11%) | ||
| Bronchitis | 33/381 (8.7%) | 27/400 (6.8%) | ||
| Urinary Tract Infection | 31/381 (8.1%) | 23/400 (5.8%) | ||
| Pneumonia | 21/381 (5.5%) | 24/400 (6%) | ||
| Cystitis | 24/381 (6.3%) | 18/400 (4.5%) | ||
| Upper Respiratory Tract Infection | 20/381 (5.2%) | 20/400 (5%) | ||
| Metabolism and nutrition disorders | ||||
| Hypercholesterolaemia | 36/381 (9.4%) | 31/400 (7.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 64/381 (16.8%) | 71/400 (17.8%) | ||
| Arthralgia | 57/381 (15%) | 47/400 (11.8%) | ||
| Osteoarthritis | 29/381 (7.6%) | 27/400 (6.8%) | ||
| Musculoskeletal Pain | 31/381 (8.1%) | 21/400 (5.3%) | ||
| Pain in Extremity | 25/381 (6.6%) | 27/400 (6.8%) | ||
| Muscle Spasms | 20/381 (5.2%) | 8/400 (2%) | ||
| Nervous system disorders | ||||
| Dizziness | 21/381 (5.5%) | 8/400 (2%) | ||
| Psychiatric disorders | ||||
| Depression | 15/381 (3.9%) | 21/400 (5.3%) | ||
| Vascular disorders | ||||
| Hypertension | 53/381 (13.9%) | 59/400 (14.8%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800-821-8590 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00551174
Other Study ID Numbers:
- MA17904
First Posted:
Oct 30, 2007
Last Update Posted:
Jul 22, 2011
Last Verified:
Jul 1, 2011