A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00081653
Collaborator
(none)
719
31
2
48
23.2
0.5
Study Details
Study Description
Brief Summary
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
719 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549
Study Start Date
:
May 1, 2004
Actual Primary Completion Date
:
Nov 1, 2007
Actual Study Completion Date
:
May 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 3 years
|
| Active Comparator: 2
|
Drug: ibandronate [Bonviva/Boniva]
100mg po monthly for 3 years
|
Outcome Measures
Primary Outcome Measures
- Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD [Baseline and Months 12, 24 and 36]
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).
- Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) [Baseline and Months 12, 24 and 36]
BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).
Secondary Outcome Measures
- Absolute Change From Baseline in Mean Total Hip BMD [Baseline and 12, 24 and 36 months]
BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
- Relative Percent Change From Baseline in Mean Total Hip BMD [Baseline, 12, 24 and 36 months]
BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
- Absolute Change From Baseline of Trough Serum CTX [Baseline, 6, 12, 24 and 36 months]
CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
- Relative Percent Change From Baseline of Trough Serum CTX [Baseline, 6,12, 24 and 36 months]
CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
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 BM16549, with at least 75% compliance;
-
ambulatory.
Exclusion Criteria:
-
malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
-
breast cancer diagnosed within the previous 22 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda | California | United States | 92357 | |
| 2 | Lakewood | Colorado | United States | 80260 | |
| 3 | Omaha | Nebraska | United States | 68131 | |
| 4 | Livingston | New Jersey | United States | 07039 | |
| 5 | Portland | Oregon | United States | 97213 | |
| 6 | Liege | Belgium | 4020 | ||
| 7 | Merksem | Belgium | 2170 | ||
| 8 | Sao Paulo | Brazil | 04026-000 | ||
| 9 | Plzen | Czechia | 305 99 | ||
| 10 | Praha | Czechia | 128 00 | ||
| 11 | Aalborg | Denmark | 9000 | ||
| 12 | Ballerup | Denmark | 2750 | ||
| 13 | Vejle | Denmark | 7100 | ||
| 14 | Lyon | France | 69000 | ||
| 15 | Berlin | Germany | 12200 | ||
| 16 | Hannover | Germany | 30167 | ||
| 17 | Balatonfuered | Hungary | 8230 | ||
| 18 | Budapest | Hungary | 1036 | ||
| 19 | Budapest | Hungary | 1083 | ||
| 20 | Kiskunhalas | Hungary | 6400 | ||
| 21 | Zalaegerszeg | Hungary | 8900 | ||
| 22 | Siena | Italy | 53100 | ||
| 23 | Leon | Mexico | 37000 | ||
| 24 | Obregon | Mexico | 85100 | ||
| 25 | Haugesund | Norway | 5507 | ||
| 26 | Stavanger | Norway | 4010 | ||
| 27 | Krakow | Poland | 31-501 | ||
| 28 | Warszawa | Poland | 04-730 | ||
| 29 | Barcelona | Spain | 08907 | ||
| 30 | Madrid | Spain | 28041 | ||
| 31 | Southampton | United Kingdom | SO16 6YD |
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:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00081653
Other Study ID Numbers:
- MA17903
First Posted:
Apr 21, 2004
Last Update Posted:
Jul 14, 2017
Last Verified:
Jul 1, 2017
Study Results
Participant Flow
| Recruitment Details | Patients were recruited from 31 centers over the period of 18 May 2004 to 28 November 2007. |
|---|---|
| Pre-assignment Detail | Eligible for the study were patients having completed Study BM16549 (NCT00081653) and who had complied with the monthly regimen for 75 percent (%) or more. |
| Arm/Group Title | Ibandronate 100 Milligrams (mg) | Ibandronate 150 mg |
|---|---|---|
| Arm/Group Description | 100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) |
| Period Title: Overall Study | ||
| STARTED | 358 | 361 |
| COMPLETED | 311 | 324 |
| NOT COMPLETED | 47 | 37 |
Baseline Characteristics
| Arm/Group Title | Ibandronate 100 mg | Ibandronate 150 mg | Total |
|---|---|---|---|
| Arm/Group Description | 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) | Total of all reporting groups |
| Overall Participants | 358 | 361 | 719 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
67.8
(6.55)
|
67.7
(6.8)
|
67.7
(6.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
358
100%
|
361
100%
|
719
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| BMI (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
25.87
(4.957)
|
26.04
(3.976)
|
25.96
(4.489)
|
| Race, Customized (participants) [Number] | |||
| Caucasian/White |
341
95.3%
|
338
93.6%
|
679
94.4%
|
| Black |
0
0%
|
1
0.3%
|
1
0.1%
|
| Oriental |
0
0%
|
1
0.3%
|
1
0.1%
|
| Hispanic |
17
4.7%
|
20
5.5%
|
37
5.1%
|
| Other |
0
0%
|
1
0.3%
|
1
0.1%
|
Outcome Measures
| Title | Absolute Change From Baseline in Mean Total Hip BMD |
|---|---|
| Description | BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones). |
| Time Frame | Baseline and 12, 24 and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population; n = number of participants analyzed for the given parameter at the specified visit. |
| Arm/Group Title | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|
| Arm/Group Description | 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) |
| Measure Participants | 347 | 348 |
| Baseline (n=345,348) |
0.7680
(0.1093)
|
0.7862
(0.1112)
|
| Month 12 (n=347,346) |
0.7669
(0.1097)
|
0.7888
(0.1116)
|
| Change from Baseline at Month 12 (n=344,345) |
-0.0004
(0.0204)
|
0.0025
(0.0200)
|
| Month 24 (n=322,336) |
0.7686
(0.1104)
|
0.7882
(0.1124)
|
| Change from Baseline at Month 24 (n=319,335) |
-0.0010
(0.0227)
|
0.0031
(0.0214)
|
| Month 36 (n=301,321) |
0.7663
(0.1133)
|
0.7834
(0.1128)
|
| Change from Baseline at Month 36 (n=298,320) |
-0.0061
(0.0254)
|
-0.0030
(0.0252)
|
| Title | Relative Percent Change From Baseline in Mean Total Hip BMD |
|---|---|
| Description | BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones). |
| Time Frame | Baseline, 12, 24 and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population; n = number of participants analyzed for the given parameter at the specified visit. |
| Arm/Group Title | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|
| Arm/Group Description | 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) |
| Measure Participants | 344 | 345 |
| Change from Baseline at Month 12 (n=344,345) |
-0.0169
(2.8582)
|
0.3459
(2.5849)
|
| Change from Baseline at Month 24 (n=319,335) |
-0.1092
(3.1040)
|
0.4378
(2.8062)
|
| Change from Baseline at Month 36 (n=298,320) |
-0.8045
(3.3448)
|
-0.3496
(3.3254)
|
| Title | Absolute Change From Baseline of Trough Serum CTX |
|---|---|
| Description | CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values. |
| Time Frame | Baseline, 6, 12, 24 and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population; n = number of participants analyzed for the given parameter at the specified visit. |
| Arm/Group Title | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|
| Arm/Group Description | 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) |
| Measure Participants | 57 | 68 |
| Baseline (n= 56,68) |
0.232
(0.1520)
|
0.219
(0.1799)
|
| Month 6 Postdose (n=56,68) |
0.176
(0.1826)
|
0.126
(0.1222)
|
| Change from Baseline at Month 6 Postdose (n=55,67) |
-0.055
(0.1307)
|
-0.093
(0.1510)
|
| Month 12 (n=57,67) |
0.279
(0.1617)
|
0.208
(0.1073)
|
| Change from Baseline at Month 12 (n=56,67) |
0.048
(0.1303)
|
-0.011
(0.1406)
|
| Month 24 (n=54,65) |
0.309
(0.1406)
|
0.266
(0.1548)
|
| Change from Baseline at Month 24 (n=53,65) |
0.088
(0.1203)
|
0.048
(0.1607)
|
| Month 36 (n=51,60) |
0.410
(0.1805)
|
0.380
(0.2036)
|
| Change from Baseline at Month 12 (n=50,60) |
0.205
(0.1396)
|
0.174
(0.1549)
|
| Title | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD |
|---|---|
| Description | Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]). |
| Time Frame | Baseline and Months 12, 24 and 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population; number (n) equals (=) number of participants analyzed at the specified visit. |
| Arm/Group Title | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|
| Arm/Group Description | 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) |
| Measure Participants | 347 | 346 |
| Baseline (n=347,346) |
0.7916
(0.0814)
|
0.7977
(0.0791)
|
| Month 12 (n=347,346) |
0.7977
(0.0831)
|
0.8069
(0.0819)
|
| Change from Baseline at Month 12 (n=346,343) |
0.0061
(0.0293)
|
0.0097
(0.0289)
|
| Month 24 (n=323,336) |
0.8048
(0.0861)
|
0.8111
(0.0852)
|
| Change from Baseline at Month 24 (n=322,333) |
0.0131
(0.0332)
|
0.0140
(0.0356)
|
| Month 36 (n=308,320) |
0.8090
(0.0916)
|
0.8155
(0.0892)
|
| Change from Baseline at Month 36 (n=307, 318) |
0.0172
(0.0382)
|
0.0194
(0.0383)
|
| Title | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) |
|---|---|
| Description | BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]). |
| Time Frame | Baseline and Months 12, 24 and 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: n = number of participants analyzed for the given parameter at the specified visit. |
| Arm/Group Title | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|
| Arm/Group Description | 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) |
| Measure Participants | 346 | 343 |
| Change from Baseline at Month 12 (n=346,343) |
0.8348
(3.8118)
|
1.2550
(3.6402)
|
| Change from Baseline at Month 24 (n=322,333) |
1.6921
(4.2385)
|
1.7865
(4.5058)
|
| Change from Baseline at Month 36 (n=307,318) |
2.1794
(4.9176)
|
2.4322
(4.8146)
|
| Title | Relative Percent Change From Baseline of Trough Serum CTX |
|---|---|
| Description | CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values. |
| Time Frame | Baseline, 6,12, 24 and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population; n = number of participants analyzed for the given parameter at the specified visit. |
| Arm/Group Title | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|
| Arm/Group Description | 100 mg ibandgronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) |
| Measure Participants | 56 | 68 |
| Baseline (n=56,68) |
0.232
(0.1520)
|
0.219
(0.1799)
|
| Month 6 Postdose (n=56, 67) |
0.176
(0.1826)
|
33.109
(40.3544)
|
| Change from Baseline at Month 6 Postdose (n=55,67) |
-24.622
(43.4212)
|
-33.109
(40.3544)
|
| Month 12 (n=57,67) |
0.279
(0.1617)
|
0.208
(0.1073)
|
| Change from Baseline at Month 12 (n=56,67) |
31.121
(58.9832)
|
25.125
(86.5607)
|
| Month 24 (n=54,65) |
0.309
(0.1406)
|
0.266
(0.1548)
|
| Change from Baseline at Month 24 (n=53,65) |
58.657
(65.3128)
|
53.704
(74.9810)
|
| Month 36 (51,60) |
0.410
(0.1805)
|
0.380
(0.2036)
|
| Change from Baseline at Month 36 (n=50,60) |
121.106
(97.9878)
|
138.502
(125.7590)
|
Adverse Events
| Time Frame | Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Ibandronate 100 mg | Ibandronate 150 mg | ||
| Arm/Group Description | 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet) | 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet) | ||
All Cause Mortality |
||||
| Ibandronate 100 mg | Ibandronate 150 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Ibandronate 100 mg | Ibandronate 150 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 68/358 (19%) | 70/361 (19.4%) | ||
| Cardiac disorders | ||||
| Myocardial infarction | 5/358 (1.4%) | 1/361 (0.3%) | ||
| Angina pectoris | 0/358 (0%) | 5/361 (1.4%) | ||
| Myocardial Ischaemia | 2/358 (0.6%) | 1/361 (0.3%) | ||
| Aortic valve stenosis | 2/358 (0.6%) | 0/361 (0%) | ||
| Atrial fibrillation | 1/358 (0.3%) | 1/361 (0.3%) | ||
| Acute myocardial infarction | 1/358 (0.3%) | 0/361 (0%) | ||
| Arrhythmia | 0/358 (0%) | 1/361 (0.3%) | ||
| Atrial flutter | 1/358 (0.3%) | 0/361 (0%) | ||
| Atrioventricular block second degree | 1/358 (0.3%) | 0/361 (0%) | ||
| Bradycardia | 0/358 (0%) | 1/361 (0.3%) | ||
| Cardiac arrest | 1/358 (0.3%) | 0/361 (0%) | ||
| Cardiac fibrillation | 0/358 (0%) | 1/361 (0.3%) | ||
| Coronary artery disease | 0/358 (0%) | 1/361 (0.3%) | ||
| Supraventricular tachycardia | 1/358 (0.3%) | 0/361 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Fibrous dysplasia of bone | 1/358 (0.3%) | 0/361 (0%) | ||
| Ear and labyrinth disorders | ||||
| Sudden hearing loss | 0/358 (0%) | 1/361 (0.3%) | ||
| Vertigo positional | 0/358 (0%) | 1/361 (0.3%) | ||
| Endocrine disorders | ||||
| Goitre | 1/358 (0.3%) | 0/361 (0%) | ||
| Hyperthyroidism | 1/358 (0.3%) | 0/361 (0%) | ||
| Eye disorders | ||||
| Cataract | 3/358 (0.8%) | 2/361 (0.6%) | ||
| Keratoconus | 0/358 (0%) | 1/361 (0.3%) | ||
| Entropion | 0/358 (0%) | 1/361 (0.3%) | ||
| Retinal detachment | 1/358 (0.3%) | 0/361 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 2/358 (0.6%) | 0/361 (0%) | ||
| Abdominal pain upper | 1/358 (0.3%) | 0/361 (0%) | ||
| Diverticular perforation | 0/358 (0%) | 1/361 (0.3%) | ||
| Gastritis | 0/358 (0%) | 1/361 (0.3%) | ||
| Hernial eventration | 0/358 (0%) | 1/361 (0.3%) | ||
| Inguinal Hernia | 1/358 (0.3%) | 0/361 (0%) | ||
| Intestinal ischaemia | 0/358 (0%) | 1/361 (0.3%) | ||
| Intestinal obstruction | 1/358 (0.3%) | 0/361 (0%) | ||
| Melaena | 0/358 (0%) | 1/361 (0.3%) | ||
| General disorders | ||||
| Chest pain | 0/358 (0%) | 1/361 (0.3%) | ||
| General physical health deterioration | 0/358 (0%) | 1/361 (0.3%) | ||
| Oedema peripheral | 0/358 (0%) | 1/361 (0.3%) | ||
| Hepatobiliary disorders | ||||
| Cholelithiasis | 2/358 (0.6%) | 0/361 (0%) | ||
| Biliary tract disorder | 0/358 (0%) | 1/361 (0.3%) | ||
| Infections and infestations | ||||
| Pneumonia | 1/358 (0.3%) | 2/361 (0.6%) | ||
| Diverticulitis | 1/358 (0.3%) | 1/361 (0.3%) | ||
| Appendicitis | 1/358 (0.3%) | 0/361 (0%) | ||
| Bronchitis | 0/358 (0%) | 1/361 (0.3%) | ||
| Cystitis | 0/358 (0%) | 1/361 (0.3%) | ||
| Infected skin ulcer | 1/358 (0.3%) | 0/361 (0%) | ||
| Pyelonephritis | 0/358 (0%) | 1/361 (0.3%) | ||
| Sinusitis | 0/358 (0%) | 1/361 (0.3%) | ||
| Tetanus | 0/358 (0%) | 1/361 (0.3%) | ||
| Ureteritis | 1/358 (0.3%) | 0/361 (0%) | ||
| Wound infection | 1/358 (0.3%) | 0/361 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/358 (0.3%) | 4/361 (1.1%) | ||
| Wrist fracture | 3/358 (0.8%) | 1/361 (0.3%) | ||
| Femur fracture | 2/358 (0.6%) | 0/361 (0%) | ||
| Radius fracture | 0/358 (0%) | 3/361 (0.8%) | ||
| Hip fracture | 2/358 (0.6%) | 0/361 (0%) | ||
| Rib fracture | 2/358 (0.6%) | 0/361 (0%) | ||
| Thoracic vertebral fracture | 1/358 (0.3%) | 1/361 (0.3%) | ||
| Bone fissure | 0/358 (0%) | 1/361 (0.3%) | ||
| Clavicle fracture | 0/358 (0%) | 1/361 (0.3%) | ||
| Contusion | 1/358 (0.3%) | 0/361 (0%) | ||
| Facial bones fracture | 0/358 (0%) | 1/361 (0.3%) | ||
| Humerus fracture | 1/358 (0.3%) | 0/361 (0%) | ||
| Lumbar vertebral fracture | 0/358 (0%) | 1/361 (0.3%) | ||
| Meniscus lesion | 0/358 (0%) | 1/361 (0.3%) | ||
| Overdose | 0/358 (0%) | 1/361 (0.3%) | ||
| Patella fracture | 1/358 (0.3%) | 0/361 (0%) | ||
| Pelvic fracture | 1/358 (0.3%) | 0/361 (0%) | ||
| Post procedural haemorrhage | 1/358 (0.3%) | 0/361 (0%) | ||
| Subdural haematoma | 1/358 (0.3%) | 0/361 (0%) | ||
| Tendon rupture | 1/358 (0.3%) | 0/361 (0%) | ||
| Investigations | ||||
| Weight decreased | 1/358 (0.3%) | 0/361 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Cachexia | 1/358 (0.3%) | 0/361 (0%) | ||
| Central obesity | 0/358 (0%) | 1/361 (0.3%) | ||
| Hyperglycaemia | 0/358 (0%) | 1/361 (0.3%) | ||
| Hyponatraemia | 1/358 (0.3%) | 0/361 (0%) | ||
| Type 2 diabetes mellitus | 0/358 (0%) | 1/361 (0.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 4/358 (1.1%) | 5/361 (1.4%) | ||
| Back pain | 3/358 (0.8%) | 0/361 (0%) | ||
| Arthralgia | 0/358 (0%) | 2/361 (0.6%) | ||
| Dupuytren's contracture | 0/358 (0%) | 1/361 (0.3%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer | 2/358 (0.6%) | 1/361 (0.3%) | ||
| Colon cancer | 1/358 (0.3%) | 1/361 (0.3%) | ||
| Adenocarcinoma pancreas | 1/358 (0.3%) | 0/361 (0%) | ||
| Bladder cancer | 1/358 (0.3%) | 0/361 (0%) | ||
| Brain neoplasm benign | 1/358 (0.3%) | 0/361 (0%) | ||
| Breast neoplasm | 0/358 (0%) | 1/361 (0.3%) | ||
| Colon cancer metastatic | 0/358 (0%) | 1/361 (0.3%) | ||
| Gastric cancer | 0/358 (0%) | 1/361 (0.3%) | ||
| Gastrointestinal neoplasm | 1/358 (0.3%) | 0/361 (0%) | ||
| Haemangioma of liver | 1/358 (0.3%) | 0/361 (0%) | ||
| Laryngeal neoplasm | 1/358 (0.3%) | 0/361 (0%) | ||
| Malignant melanoma | 1/358 (0.3%) | 0/361 (0%) | ||
| Medullary thyroid cancer | 0/358 (0%) | 1/361 (0.3%) | ||
| Metastatic gastric cancer | 1/358 (0.3%) | 0/361 (0%) | ||
| Metastatic renal cell carcinoma | 1/358 (0.3%) | 0/361 (0%) | ||
| Multiple myeloma | 0/358 (0%) | 1/361 (0.3%) | ||
| Peritoneal carcinoma | 0/358 (0%) | 1/361 (0.3%) | ||
| Rectal cancer | 1/358 (0.3%) | 0/361 (0%) | ||
| Rectal neoplasm | 1/358 (0.3%) | 0/361 (0%) | ||
| Signet-ring cell carcinoma | 1/358 (0.3%) | 0/361 (0%) | ||
| Skin cancer | 0/358 (0%) | 1/361 (0.3%) | ||
| Nervous system disorders | ||||
| Vertebrobasilar insufficiency | 2/358 (0.6%) | 0/361 (0%) | ||
| Carpal tunnel syndrome | 0/358 (0%) | 1/361 (0.3%) | ||
| Cerebrovascular accident | 0/358 (0%) | 1/361 (0.3%) | ||
| Facial paresis | 1/358 (0.3%) | 0/361 (0%) | ||
| Hemiparesis | 1/358 (0.3%) | 0/361 (0%) | ||
| Transient ischaemic attack | 0/358 (0%) | 1/361 (0.3%) | ||
| Psychiatric disorders | ||||
| Confusional state | 1/358 (0.3%) | 0/361 (0%) | ||
| Renal and urinary disorders | ||||
| Urinary incontinence | 0/358 (0%) | 2/361 (0.6%) | ||
| Bladder prolapse | 0/358 (0%) | 1/361 (0.3%) | ||
| Nephrolithiasis | 1/358 (0.3%) | 0/361 (0%) | ||
| Renal artery stenosis | 0/358 (0%) | 1/361 (0.3%) | ||
| Ureteric obstruction | 1/358 (0.3%) | 0/361 (0%) | ||
| Reproductive system and breast disorders | ||||
| Cystocele | 0/358 (0%) | 3/361 (0.8%) | ||
| Uterine prolapse | 1/358 (0.3%) | 1/361 (0.3%) | ||
| Cervix disorder | 1/358 (0.3%) | 0/361 (0%) | ||
| Genital prolapse | 0/358 (0%) | 1/361 (0.3%) | ||
| Ovarian cyst | 0/358 (0%) | 1/361 (0.3%) | ||
| Rectocele | 0/358 (0%) | 1/361 (0.3%) | ||
| Vaginal disorder | 1/358 (0.3%) | 0/361 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary embolism | 1/358 (0.3%) | 1/361 (0.3%) | ||
| Chronic obstructive pulmonary disease | 1/358 (0.3%) | 0/361 (0%) | ||
| Dyspnoea | 0/358 (0%) | 1/361 (0.3%) | ||
| Pleural effusion | 1/358 (0.3%) | 0/361 (0%) | ||
| Pulmonary sarcoidosis | 0/358 (0%) | 1/361 (0.3%) | ||
| Surgical and medical procedures | ||||
| Diabetes mellitus management | 0/358 (0%) | 1/361 (0.3%) | ||
| Vascular disorders | ||||
| Aortic aneurysm | 1/358 (0.3%) | 1/361 (0.3%) | ||
| Deep vein thrombosis | 2/358 (0.6%) | 0/361 (0%) | ||
| Hypertension | 1/358 (0.3%) | 1/361 (0.3%) | ||
| Varicose vein | 0/358 (0%) | 2/361 (0.6%) | ||
| Intermittent claudication | 0/358 (0%) | 1/361 (0.3%) | ||
| Peripheral arterial occlusive disease | 0/358 (0%) | 1/361 (0.3%) | ||
| Temporal arteritis | 0/358 (0%) | 1/361 (0.3%) | ||
| Thrombophlebitis | 1/358 (0.3%) | 0/361 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ibandronate 100 mg | Ibandronate 150 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 187/358 (52.2%) | 185/361 (51.2%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 46/358 (12.8%) | 40/361 (11.1%) | ||
| Urinary tract infection | 22/358 (6.1%) | 27/361 (7.5%) | ||
| Bronchitis | 24/358 (6.7%) | 21/361 (5.8%) | ||
| Influenza | 22/358 (6.1%) | 15/361 (4.2%) | ||
| Metabolism and nutrition disorders | ||||
| Hypercholesterolaemia | 30/358 (8.4%) | 23/361 (6.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 32/358 (8.9%) | 31/361 (8.6%) | ||
| Back pain | 32/358 (8.9%) | 36/361 (10%) | ||
| Osteoarthritis | 19/358 (5.3%) | 24/361 (6.6%) | ||
| Pain in extremity | 18/358 (5%) | 15/361 (4.2%) | ||
| Vascular disorders | ||||
| Hypertension | 42/358 (11.7%) | 49/361 (13.6%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
| Name/Title | Clinical Trials Study Director |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | +1 973 235 5000 |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00081653
Other Study ID Numbers:
- MA17903
First Posted:
Apr 21, 2004
Last Update Posted:
Jul 14, 2017
Last Verified:
Jul 1, 2017