MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00048061
Collaborator
(none)
1,609
68
4
32
23.7
0.7
Study Details
Study Description
Brief Summary
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. 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 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1609 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis
Study Start Date
:
Apr 1, 2002
Actual Primary Completion Date
:
Dec 1, 2004
Actual Study Completion Date
:
Dec 1, 2004
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ibandronate 2.5 mg Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day . |
Drug: Ibandronate [Bonviva/Boniva]
2.5mg po daily
Dietary Supplement: Calcium
500 mg/day
Dietary Supplement: Vitamin D
400 IU/day
|
| Experimental: Ibandronate 50/50 mg Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day. |
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Dietary Supplement: Calcium
500 mg/day
Dietary Supplement: Vitamin D
400 IU/day
|
| Experimental: Ibandronate 100 mg Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day |
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Dietary Supplement: Calcium
500 mg/day
Dietary Supplement: Vitamin D
400 IU/day
|
| Experimental: Ibandronate 150 mg Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day |
Drug: Ibandronate [Bonviva/Boniva]
150mg po monthly
Dietary Supplement: Calcium
500 mg/day
Dietary Supplement: Vitamin D
400 IU/day
|
Outcome Measures
Primary Outcome Measures
- Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density [From Baseline (Month 0) to Month 12]
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
Secondary Outcome Measures
- Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD [From Baseline (Month 0) to Month 24]
Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.
- Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD [From Baseline (Month 0) to Months 12 and 24]
The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.
- Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD [From Baseline (Month 0) to Months 12 and 24]
Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.
- Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. [From Baseline (Month 0) to Months 12 and 24]
Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center
- Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 [Months 12 and 24]
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
- Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 [Months 12 and 24]
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
- Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 [Months 12 and 24]
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
- Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 [Months 12 and 24]
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
- Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 [Months 12 and 24]
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
- Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 [Months 12 and 24]
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
- Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 [Months 12 and 24]
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
- Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 [From Baseline (Month 0) to Months 3, 6, 12, 24]
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
- Absolute Change In Baseline in Serum CTX to Months 12 and 24 [From Baseline (Month 0) to Months 12 and 24]
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
- Number of Participants With Any Adverse Events and Serious Adverse Event [Up to Month 24]
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
- Number Of Participants With Marked Laboratory Abnormalities [Up to Month 24]
Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
women 55-80 years of age;
-
post-menopausal for >= 5 years;
-
ambulatory.
Exclusion Criteria:
-
malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
-
breast cancer within the previous 20 years;
-
allergy to bisphosphonates;
-
previous treatment with an intravenous bisphosphonate at any time;
-
previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Irvine | California | United States | 92618 | |
| 2 | Loma Linda | California | United States | 92357 | |
| 3 | Los Angeles | California | United States | 90211 | |
| 4 | Oakland | California | United States | 94612 | |
| 5 | Rancho Mirage | California | United States | 92270 | |
| 6 | Lakewood | Colorado | United States | 80227 | |
| 7 | Gainesville | Florida | United States | 32607 | |
| 8 | Bethesda | Maryland | United States | 20817 | |
| 9 | Wheaton | Maryland | United States | 20902 | |
| 10 | Saint Louis | Missouri | United States | 63110 | |
| 11 | Billings | Montana | United States | 59120 | |
| 12 | Omaha | Nebraska | United States | 68131 | |
| 13 | Livingston | New Jersey | United States | 07039 | |
| 14 | Albuquerque | New Mexico | United States | 87106 | |
| 15 | Portland | Oregon | United States | 97213 | |
| 16 | Wyomissing | Pennsylvania | United States | 19610 | |
| 17 | San Antonio | Texas | United States | 78229 | |
| 18 | Richmond | Virginia | United States | 23294 | |
| 19 | Seattle | Washington | United States | 98144 | |
| 20 | Madison | Wisconsin | United States | 53792 | |
| 21 | Adelaide | Australia | 5000 | ||
| 22 | Adelaide | Australia | 5035 | ||
| 23 | Parkville | Australia | 3052 | ||
| 24 | Perth | Australia | 6979 | ||
| 25 | Liege | Belgium | 4020 | ||
| 26 | Merksem | Belgium | 2170 | ||
| 27 | Campinas | Brazil | 13077-005 | ||
| 28 | Curitiba | Brazil | 80060-240 | ||
| 29 | Porto Alegre | Brazil | 90035-003 | ||
| 30 | Sao Paulo | Brazil | 04026-000 | ||
| 31 | Calgary | Alberta | Canada | T2N 4N1 | |
| 32 | Vancouver | British Columbia | Canada | V5Z 2N6 | |
| 33 | Toronto | Ontario | Canada | M5S 1B2 | |
| 34 | Quebec City | Quebec | Canada | G1V 3M7 | |
| 35 | Plzen | Czechia | 305 99 | ||
| 36 | Praha | Czechia | 128 00 | ||
| 37 | Praha | Czechia | 169 02 | ||
| 38 | Aalborg | Denmark | 9000 | ||
| 39 | Ballerup | Denmark | 2750 | ||
| 40 | Vejle | Denmark | 7100 | ||
| 41 | Caen | France | 14033 | ||
| 42 | Lyon | France | 69437 | ||
| 43 | Berlin | Germany | 12200 | ||
| 44 | Hannover | Germany | 30167 | ||
| 45 | Balatonfuered | Hungary | 8230 | ||
| 46 | Budapest | Hungary | 1036 | ||
| 47 | Budapest | Hungary | 1083 | ||
| 48 | Kiskunhalas | Hungary | 6400 | ||
| 49 | Zalaegerszeg | Hungary | 8900 | ||
| 50 | Siena | Italy | 53100 | ||
| 51 | Valeggio Sul Mincio | Italy | 37067 | ||
| 52 | Leon | Mexico | 37000 | ||
| 53 | Obregon | Mexico | 85100 | ||
| 54 | Haugesund | Norway | 5507 | ||
| 55 | Oslo | Norway | 0176 | ||
| 56 | Stavanger | Norway | 4010 | ||
| 57 | Krakow | Poland | 31-501 | ||
| 58 | Warszawa | Poland | 04-730 | ||
| 59 | Bucharest | Romania | 011025 | ||
| 60 | Cape Town | South Africa | 7500 | ||
| 61 | Johannesburg | South Africa | 2196 | ||
| 62 | Barcelona | Spain | 08907 | ||
| 63 | Madrid | Spain | 28041 | ||
| 64 | Zürich | Switzerland | 8091 | ||
| 65 | Cardiff | United Kingdom | CF64 2XX | ||
| 66 | Liverpool | United Kingdom | L22 0LG | ||
| 67 | London | United Kingdom | E11 1NR | ||
| 68 | 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
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048061
Other Study ID Numbers:
- BM16549
First Posted:
Oct 25, 2002
Last Update Posted:
Mar 29, 2018
Last Verified:
Feb 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted from 26 April 2002 to 08 Dec 2004 across 65 centers in the world. |
|---|---|
| Pre-assignment Detail | A total of 1609 participants were randomized, of which 1602 received the study drug. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Period Title: Overall Study | ||||
| STARTED | 400 | 401 | 400 | 401 |
| COMPLETED | 325 | 328 | 316 | 322 |
| NOT COMPLETED | 75 | 73 | 84 | 79 |
Baseline Characteristics
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Total of all reporting groups |
| Overall Participants | 395 | 396 | 396 | 396 | 1583 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
65.8
(6.61)
|
66.0
(6.71)
|
66.2
(6.38)
|
66.2
(6.64)
|
66.0
(6.58)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
395
100%
|
396
100%
|
396
100%
|
396
100%
|
1583
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density |
|---|---|
| Description | Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis. |
| Time Frame | From Baseline (Month 0) to Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 314 | 322 | 306 | 314 |
| Mean (Standard Deviation) [Percent change] |
3.7427
(4.0149)
|
4.3395
(3.9557)
|
4.0328
(3.6815)
|
4.7611
(3.8931)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ibandronate 2.5 mg, Ibandronate 50/50 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point. | |
| Statistical Test of Hypothesis | p-Value | 0.045 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.615 | |
| Confidence Interval |
(2-Sided) 95% 0.013 to 1.216 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Ibandronate 2.5 mg, Ibandronate 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point. | |
| Statistical Test of Hypothesis | p-Value | 0.338 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.297 | |
| Confidence Interval |
(2-Sided) 95% -0.312 to 0.906 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ibandronate 2.5 mg, Ibandronate 150 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point. | |
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.000 | |
| Confidence Interval |
(2-Sided) 95% 0.395 to 1.605 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control. | |
| Title | Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD |
|---|---|
| Description | Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24. |
| Time Frame | From Baseline (Month 0) to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 294 | 294 | 278 | 291 |
| Mean (Standard Deviation) [Percent change] |
4.9623
(4.6525)
|
5.3350
(4.8235)
|
5.5760
(4.2280)
|
6.5503
(4.5118)
|
| Title | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD |
|---|---|
| Description | The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated. |
| Time Frame | From Baseline (Month 0) to Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 314 | 322 | 306 | 314 |
| At 12 months, n = 314, 322, 306, 314 |
0.028
(0.0291)
|
0.033
(0.0298)
|
0.030
(0.0271)
|
0.036
(0.0290)
|
| At 24 months, n = 294, 294, 278, 291 |
0.036
(0.0337)
|
0.039
(0.0355)
|
0.042
(0.0313)
|
0.049
(0.0330)
|
| Title | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD |
|---|---|
| Description | Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center. |
| Time Frame | From Baseline (Month 0) to Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 315 | 319 | 306 | 316 |
| Total hip At Month 12, n = 315,319,306,316 |
1.9626
(2.8311)
|
2.2172
(2.7504)
|
2.6878
(2.6646)
|
3.0092
(2.7105)
|
| Total hip At Month 24, n = 292,291,277,289 |
2.4955
(3.0884)
|
2.8132
(3.2408)
|
3.5165
(3.2831)
|
4.1601
(2.8335)
|
| Trochanter At Month 12, n = 315,319,306,316 |
3.1917
(4.1268)
|
3.4931
(4.0876)
|
3.8226
(3.7077)
|
4.5904
(3.9436)
|
| Trochanter At Month 24, n = 292,291,277,289 |
4.0204
(4.3460)
|
4.6289
(4.5518)
|
5.3135
(4.7335)
|
6.1755
(4.2550)
|
| Femoral neck At Month 12, n = 315,319,306,316 |
1.7164
(3.6233)
|
1.8141
(3.4391)
|
1.8797
(3.4998)
|
2.1914
(3.4842)
|
| Femoral neck At Month 24, n=292,291,277,289 |
1.9087
(4.2212)
|
2.0581
(4.1189)
|
2.6209
(3.8339)
|
3.1195
(4.0549)
|
| Title | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. |
|---|---|
| Description | Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center |
| Time Frame | From Baseline (Month 0) to Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 315 | 319 | 306 | 316 |
| Total hip At Month 12, n = 315,319,306,316 |
0.014
(0.0204)
|
0.016
(0.0205)
|
0.020
(0.0190)
|
0.022
(0.0190)
|
| Total hip At Month 24, n = 292,291,277,290 |
0.018
(0.0225)
|
0.021
(0.0241)
|
0.026
(0.0237)
|
0.031
(0.0199)
|
| Trochanter At Month 12, n = 315,319,306,316 |
0.018
(0.0228)
|
0.020
(0.0238)
|
0.022
(0.0206)
|
0.026
(0.0211)
|
| Trochanter At Month 24, n = 292,291,277,290 |
0.023
(0.0241)
|
0.027
(0.0259)
|
0.030
(0.0263)
|
0.035
(0.0231)
|
| Femoral neck At Month 12, n = 315,319,306,316 |
0.011
(0.0230)
|
0.011
(0.0226)
|
0.012
(0.0228)
|
0.014
(0.0224)
|
| Femoral neck At Month 24, n = 315,319,306,316 |
0.012
(0.0265)
|
0.013
(0.0272)
|
0.017
(0.0248)
|
0.020
(0.0257)
|
| Title | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. |
| Time Frame | Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 314 | 322 | 306 | 314 |
| At Month 12, n = 314,322,306,314 |
83.8
21.2%
|
87.6
22.1%
|
86.6
21.9%
|
90.8
22.9%
|
| At Month 24, n = 294,294,278,291 |
86.4
21.9%
|
87.8
22.2%
|
87.8
22.2%
|
93.5
23.6%
|
| Title | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. |
| Time Frame | Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 315 | 319 | 306 | 306 |
| At Month 12, n = 315,319,306,306 |
76.8
19.4%
|
81.2
20.5%
|
86.9
21.9%
|
90.5
22.9%
|
| At Month 24, n = 292,291,277,289 |
78.4
19.8%
|
83.2
21%
|
88.8
22.4%
|
93.4
23.6%
|
| Title | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. |
| Time Frame | Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 315 | 319 | 306 | 316 |
| At Month 12, n = 315,319,306,316 |
80.0
20.3%
|
83.1
21%
|
88.2
22.3%
|
92.4
23.3%
|
| At Month 24, n = 292,291,277,289 |
84.2
21.3%
|
86.6
21.9%
|
89.9
22.7%
|
94.1
23.8%
|
| Title | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. |
| Time Frame | Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 315 | 319 | 306 | 316 |
| At Month 12, n = 315,319,306,316 |
71.1
18%
|
72.4
18.3%
|
69.0
17.4%
|
75.3
19%
|
| At Month 24, n = 292,291,277,289 |
69.2
17.5%
|
71.1
18%
|
78.7
19.9%
|
81.0
20.5%
|
| Title | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. |
| Time Frame | Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 314 | 318 | 304 | 310 |
| At Month 12, n = 314,318,304,310 |
65.6
16.6%
|
72.3
18.3%
|
77.6
19.6%
|
83.5
21.1%
|
| At Month 24, n = 292,291,276,287 |
70.5
17.8%
|
75.3
19%
|
79.3
20%
|
87.1
22%
|
| Title | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. |
| Time Frame | Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 314 | 318 | 304 | 310 |
| At Month 12, n = 314,318,304,310 |
68.8
17.4%
|
75.5
19.1%
|
78.0
19.7%
|
84.2
21.3%
|
| At Month 24, n = 292,291,276,287 |
75.7
19.2%
|
77.3
19.5%
|
80.1
20.2%
|
88.2
22.3%
|
| Title | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. |
| Time Frame | Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 314 | 318 | 304 | 310 |
| At Month 12, n = 314,318,304,310 |
62.4
15.8%
|
64.5
16.3%
|
60.9
15.4%
|
68.7
17.3%
|
| At Month 24, n = 292,291,276,287 |
63.4
16.1%
|
63.9
16.1%
|
71.0
17.9%
|
75.6
19.1%
|
| Title | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 |
|---|---|
| Description | Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique). |
| Time Frame | From Baseline (Month 0) to Months 3, 6, 12, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 272 | 278 | 276 | 278 |
| At Month 3, n = 269,278,271,276 |
-49.5458
(30.8286)
|
-46.4771
(26.5096)
|
-50.2368
(28.1576)
|
-57.3433
(33.9505)
|
| At Month 6, n = 270,272,274,278 |
55.5900
(34.1672)
|
-53.9838
(27.3557)
|
-55.9614
(31.2801)
|
-66.4354
(25.4762)
|
| At Month 12, n = 272,276,276,267 |
-58.8244
(29.8250)
|
-57.5363
(27.2271)
|
-58.1046
(33.5095)
|
-67.0703
(41.4563)
|
| At Month 24, n = 221,215,211,235 |
-51.2360
(37.9032)
|
-51.3040
(27.9844)
|
-49.5567
(44.9707)
|
61.8822
(28.2309)
|
| Title | Absolute Change In Baseline in Serum CTX to Months 12 and 24 |
|---|---|
| Description | Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique). |
| Time Frame | From Baseline (Month 0) to Months 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 272 | 276 | 276 | 267 |
| Month 12, n = 272, 276, 276, 267 |
-0.323
(0.2292)
|
-0.326
(0.2212)
|
-0.340
(0.2287)
|
-0.377
(0.2135)
|
| Month 24, n = 221, 215, 211, 235 |
-0.285
(0.2052)
|
-0.298
(0.1980)
|
-0.312
(0.2398)
|
-0.340
(0.2062)
|
| Title | Number of Participants With Any Adverse Events and Serious Adverse Event |
|---|---|
| Description | An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
| Time Frame | Up to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 395 | 396 | 396 | 396 |
| Any AE |
302
76.5%
|
313
79%
|
318
80.3%
|
317
80.1%
|
| SAE |
38
9.6%
|
54
13.6%
|
55
13.9%
|
45
11.4%
|
| Title | Number Of Participants With Marked Laboratory Abnormalities |
|---|---|
| Description | Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L]. |
| Time Frame | Up to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment. |
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. |
| Measure Participants | 390 | 390 | 385 | 385 |
| Hematocrit Low, n = 389,387,382,385 |
2
0.5%
|
0
0%
|
1
0.3%
|
3
0.8%
|
| Hemoglobin High, n = 389,389,382,385 |
0
0%
|
0
0%
|
1
0.3%
|
0
0%
|
| Hemoglobin Low, n = 389,389,382,385 |
3
0.8%
|
3
0.8%
|
6
1.5%
|
3
0.8%
|
| WBC Low, n = 389,389,382,385 |
1
0.3%
|
1
0.3%
|
4
1%
|
4
1%
|
| ALT (SGPT) High, n = 390,390,385,385 |
9
2.3%
|
8
2%
|
8
2%
|
8
2%
|
| BUN High, n = 390,390,385,385 |
2
0.5%
|
0
0%
|
0
0%
|
0
0%
|
| Creatinine High, n = 390,390,385,385 |
1
0.3%
|
1
0.3%
|
0
0%
|
1
0.3%
|
| Chloride Low, n =3 89,390,385,384 |
3
0.8%
|
3
0.8%
|
0
0%
|
3
0.8%
|
| Potassium Low, n = 389,390,385,383 |
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Sodium High, n = 389,390,385,384 |
0
0%
|
0
0%
|
1
0.3%
|
2
0.5%
|
| Sodium Low, n = 389,390,385,384 |
2
0.5%
|
1
0.3%
|
0
0%
|
0
0%
|
| Calcium High, n = 390,390,385,385 |
1
0.3%
|
0
0%
|
0
0%
|
1
0.3%
|
| Phosphate High, n = 390,390,385,385 |
4
1%
|
3
0.8%
|
3
0.8%
|
1
0.3%
|
| Phosphate Low, n = 390,390,385,385 |
2
0.5%
|
2
0.5%
|
2
0.5%
|
1
0.3%
|
Adverse Events
| Time Frame | 24 months | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point. | |||||||
| Arm/Group Title | Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg | ||||
| Arm/Group Description | Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. | ||||
All Cause Mortality |
||||||||
| Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/395 (9.6%) | 54/396 (13.6%) | 55/396 (13.9%) | 45/396 (11.4%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Iron deficiency anaemia | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Anaemia | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Cardiac disorders | ||||||||
| Cardiac failure | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 3/396 (0.8%) | ||||
| Myocardial ischemia | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 2/396 (0.5%) | ||||
| Acute myocardial infarction | 2/395 (0.5%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Angina pectoris | 0/395 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | 1/396 (0.3%) | ||||
| Atrial fibrillation | 1/395 (0.3%) | 2/396 (0.5%) | 0/396 (0%) | 0/396 (0%) | ||||
| Coronary artery disease | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Myocardial infarction | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Tachycardia | 0/395 (0%) | 0/396 (0%) | 2/396 (0.5%) | 0/396 (0%) | ||||
| Acute coronary syndrome | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Angina unstable | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Cardiac failure congestive | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Cardiopulmonary failure | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Coronary artery stenosis | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Left ventricular failure | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Tachyarrhythmia | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Dermoid cyst of ovary | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Ear and labyrinth disorders | ||||||||
| Vestibular neuronitis | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Endocrine disorders | ||||||||
| Autoimmune thyroiditis | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Hyperparathyroidism | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Hyperparathyroidism primary | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Hyperthyroidism | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Eye disorders | ||||||||
| Cataract | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Diplopia | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Macular hole | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Gastrointestinal disorders | ||||||||
| Gastric ulcer | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Intestinal obstruction | 1/395 (0.3%) | 0/396 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | ||||
| Melaena | 2/395 (0.5%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Abdominal pain upper | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Colonic polyp | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Abdominal pain | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Appendicitis perforated | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Colitis ischaemic | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Colitis ulcerative | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Constipation | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Diarrhoea | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Duodenal ulcer | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Erosive duodenitis | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Gastric ulcer haemorrhage | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Gastritis haemorrhagic | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Gastrooesophageal reflux disease | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Pancreatitis | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Rectal haemorrhage | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Reflux gastritis | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Umbilical hernia | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| General disorders | ||||||||
| Chest pain | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 2/396 (0.5%) | ||||
| Adverse drug reaction | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Pyrexia | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 1/395 (0.3%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Bile duct obstruction | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Liver disorder | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Infections and infestations | ||||||||
| Pneumonia | 3/395 (0.8%) | 1/396 (0.3%) | 2/396 (0.5%) | 2/396 (0.5%) | ||||
| Cellulitis | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Lower respiratory tract Infection | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | ||||
| Appendicitis | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Bronchial infection | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Chronic sinusitis | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Conjunctivitis bacterial | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Dacryocystitis infective | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Ear infection | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Ear infection viral | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Erysipelas | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Gangrene | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Hematoma infection | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Herpes zoster | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Laryngopharyngitis | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Postoperative abscess | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Pulmonary tuberculosis | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Pyelonephritis | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Salmonellosis | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Superinfection | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Superinfection lung | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Urosepsis | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Gastrointestinal haemorrhage | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Concussion | 1/395 (0.3%) | 1/396 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Femur fracture | 0/395 (0%) | 2/396 (0.5%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Cardiac pacemaker malfunction | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Foot fracture | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Head injury | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Humerus fracture | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Lower limb fracture | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Meniscus lesion | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Pain trauma activated | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Patella fracture | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Pelvic fracture | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Pubic rami fracture | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Radius fracture | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Rib fracture | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Spinal compression fracture | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Thoracic vertebral fracture | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Upper limb fracture | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Vascular graft occlusion | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Diabetes mellitus | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Localised osteoarthritis | 0/395 (0%) | 4/396 (1%) | 1/396 (0.3%) | 2/396 (0.5%) | ||||
| Arthralgia | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Bursitis | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Intervertebral disc protrusion | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Osteitis | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Osteoarthritis | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Polymyalgia rheumatica | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Pseudarthrosis | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Spondylosis | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Toe deformity | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Breast cancer | 1/395 (0.3%) | 1/396 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Colon cancer | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Endometrial cancer | 0/395 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Lung neoplasm malignant | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | ||||
| Small cell lung cancer stage unspecified | 0/395 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Benign neoplasm of bladder | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Breast cancer in situ | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Bronchial carcinoma | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Cholesteatoma | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Colon cancer metastatic | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Gammopathy | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Lipoma | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Meningioma | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Ovarian epithelial cancer | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Rectosigmoid cancer | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Thyroid neoplasm | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Nervous system disorders | ||||||||
| Syncope | 0/395 (0%) | 1/396 (0.3%) | 2/396 (0.5%) | 0/396 (0%) | ||||
| Cerebrovascular accident | 0/395 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Vertebrobasilar insufficiency | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Aphasia | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Dementia alzheimer's type | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Embolic stroke | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Facial palsy | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Facial paresis | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Haemorrhagic cerebral infarction | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Loss of consciousness | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Neuropathy peripheral | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Parkinson's disease | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Parkinsonism | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Sciatica | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Transient ischaemic attack | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Back pain | 1/395 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Psychiatric disorders | ||||||||
| Depression | 1/395 (0.3%) | 2/396 (0.5%) | 2/396 (0.5%) | 0/396 (0%) | ||||
| Anxiety | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Bipolar disorder | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Major depression | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Suicide attempt | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Nephrolithiasis | 0/395 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | 1/396 (0.3%) | ||||
| Cystocele | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Renal colic | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Urethral syndrome | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Urinary incontinence | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Cervical polyp | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Endometrial hypertrophy | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Pelvic prolapse | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Uterine prolapse | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Vaginal prolapse | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pulmonary embolism | 0/395 (0%) | 0/396 (0%) | 2/396 (0.5%) | 0/396 (0%) | ||||
| Chronic obstructive airways disease | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Cough | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Emphysema | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Hyperventilation | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Laryngeal polyp | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Pulmonary fibrosis | 0/395 (0%) | 0/396 (0%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Cutaneous lupus erythematosus | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Skin necrosis | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Surgical and medical procedures | ||||||||
| Cyst removal | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 0/396 (0%) | ||||
| Eventration procedure | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 1/395 (0.3%) | 2/396 (0.5%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Aortic aneurysm | 0/395 (0%) | 1/396 (0.3%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Haematoma | 0/395 (0%) | 1/396 (0.3%) | 1/396 (0.3%) | 0/396 (0%) | ||||
| Hypotension | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
| Intermittent claudication | 0/395 (0%) | 0/396 (0%) | 0/396 (0%) | 1/396 (0.3%) | ||||
| Vascular pseudoaneurysm | 1/395 (0.3%) | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Ibandronate 2.5 mg | Ibandronate 50/50 mg | Ibandronate 100 mg | Ibandronate 150 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 190/395 (48.1%) | 190/396 (48%) | 191/396 (48.2%) | 182/396 (46%) | ||||
| Gastrointestinal disorders | ||||||||
| Nausea | 20/395 (5.1%) | 19/396 (4.8%) | 18/396 (4.5%) | 25/396 (6.3%) | ||||
| Diarrhoea | 21/395 (5.3%) | 20/396 (5.1%) | 16/396 (4%) | 19/396 (4.8%) | ||||
| Dyspepsia | 28/395 (7.1%) | 29/396 (7.3%) | 37/396 (9.3%) | 26/396 (6.6%) | ||||
| Infections and infestations | ||||||||
| Nasopharyngitis | 38/395 (9.6%) | 23/396 (5.8%) | 27/396 (6.8%) | 24/396 (6.1%) | ||||
| Influenza | 25/395 (6.3%) | 31/396 (7.8%) | 18/396 (4.5%) | 26/396 (6.6%) | ||||
| Urinary tract infection | 15/395 (3.8%) | 18/396 (4.5%) | 15/396 (3.8%) | 19/396 (4.8%) | ||||
| Bronchitis | 20/395 (5.1%) | 10/396 (2.5%) | 18/396 (4.5%) | 12/396 (3%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hypercholesterolaemia | 21/395 (5.3%) | 9/396 (2.3%) | 16/396 (4%) | 18/396 (4.5%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 24/395 (6.1%) | 39/396 (9.8%) | 35/396 (8.8%) | 27/396 (6.8%) | ||||
| Back pain | 25/395 (6.3%) | 36/396 (9.1%) | 36/396 (9.1%) | 28/396 (7.1%) | ||||
| Pain in extremity | 9/395 (2.3%) | 14/396 (3.5%) | 13/396 (3.3%) | 20/396 (5.1%) | ||||
| Localised osteoarthritis | 10/395 (2.5%) | 12/396 (3%) | 12/396 (3%) | 19/396 (4.8%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 46/395 (11.6%) | 43/396 (10.9%) | 47/396 (11.9%) | 41/396 (10.4%) | ||||
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 | Roche Trial Information Hotline |
|---|---|
| Organization | F. Hoffmann-La Roche AG |
| Phone | +41 616878333 |
| global.trial_information@roche.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048061
Other Study ID Numbers:
- BM16549
First Posted:
Oct 25, 2002
Last Update Posted:
Mar 29, 2018
Last Verified:
Feb 1, 2018