DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00048074
Collaborator
(none)
1,395
64
3
35
21.8
0.6
Study Details
Study Description
Brief Summary
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. 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
:
1395 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis
Study Start Date
:
Jun 1, 2002
Actual Primary Completion Date
:
May 1, 2005
Actual Study Completion Date
:
May 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 oral placebo daily and IV ibandronate 2 mg q 2 mo |
Drug: ibandronate [Bonviva/Boniva]
2mg iv every 2 months
|
| Experimental: 2 oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo |
Drug: ibandronate [Bonviva/Boniva]
2.5mg po daily
|
| Experimental: 3 oral placebo daily and IV ibandronate 3 mg q 3 mo |
Drug: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
|
Outcome Measures
Primary Outcome Measures
- Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months [Baseline and Month 12]
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Secondary Outcome Measures
- Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months [Baseline and Month 24]
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
- Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 [Baseline, Month 12 and Month 24]
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
- Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 [Baseline, Month 12 and Month 24]
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
- Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 [Baseline, Month 12 and Month 24]
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
- Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 [Baseline, At Month 6, 12, and 24.]
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.
- Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 [Baseline, At Month 6, 12, and 24.]
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
- Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 [At Month 12 and 24]
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
- Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 [At Month 12 and 24]
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
- Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 [At Month 12 and 24]
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
- Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 [At Month 12 and 24]
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
- Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 [At Month 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. Only participants with data available at particular timepoint were analyzed.
- Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 [At Month 12 and 24]
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
- Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24 [At Month 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. Only participants with data available at particular timepoint were analyzed.
- Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) [Approximately 2 years]
An 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 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 Any Marked Abnormality in Laboratory Parameters [Approximately 2 years]
Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 * 10^9/L), low and high white blood cell (WBC) (3.0 - 18.0 * 10^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/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 | Little Rock | Arkansas | United States | 72205-7199 | |
| 2 | Irvine | California | United States | 92618 | |
| 3 | Rancho Mirage | California | United States | 92270 | |
| 4 | Leesburg | Florida | United States | 34748 | |
| 5 | Gainesville | Georgia | United States | 30501 | |
| 6 | Coeur D'alene | Idaho | United States | 83814 | |
| 7 | Bethesda | Maryland | United States | 20817 | |
| 8 | St Louis | Missouri | United States | 63110 | |
| 9 | Billings | Montana | United States | 59120 | |
| 10 | Omaha | Nebraska | United States | 68131 | |
| 11 | Albuquerque | New Mexico | United States | 87106 | |
| 12 | New York | New York | United States | 10029 | |
| 13 | Bismarck | North Dakota | United States | 58503 | |
| 14 | Fargo | North Dakota | United States | 58103 | |
| 15 | Wyomissing | Pennsylvania | United States | 19610 | |
| 16 | Rapid City | South Dakota | United States | 57701 | |
| 17 | San Antonio | Texas | United States | 78229 | |
| 18 | Virginia Beach | Virginia | United States | 23462 | |
| 19 | Madison | Wisconsin | United States | 53792 | |
| 20 | Darlinghurst | Australia | 2010 | ||
| 21 | Melbourne | Australia | 3084 | ||
| 22 | Nedlands | Australia | 6000 | ||
| 23 | St. Leonards | Australia | 2139 | ||
| 24 | Sydney | Australia | 3129 | ||
| 25 | Bruxelles | Belgium | 1180 | ||
| 26 | Liege | Belgium | 4020 | ||
| 27 | Toronto | Ontario | Canada | M5C 2T2 | |
| 28 | Laval | Quebec | Canada | H7T 2P5 | |
| 29 | Montreal | Quebec | Canada | H2X 3J4 | |
| 30 | Montreal | Quebec | Canada | H3A 1A1 | |
| 31 | Saskatoon | Saskatchewan | Canada | S7K 0H6 | |
| 32 | Plzen | Czech Republic | 305 99 | ||
| 33 | Praha | Czech Republic | 128 00 | ||
| 34 | Aalborg | Denmark | 9000 | ||
| 35 | Ballerup | Denmark | 2750 | ||
| 36 | København | Denmark | 1399 | ||
| 37 | Vejle | Denmark | 7100 | ||
| 38 | Århus | Denmark | 8000 | ||
| 39 | Lyon | France | 69437 | ||
| 40 | Orleans | France | 45000 | ||
| 41 | Berlin | Germany | 12200 | ||
| 42 | Bochum | Germany | 44789 | ||
| 43 | Hamburg | Germany | 20246 | ||
| 44 | Budapest | Hungary | 1036 | ||
| 45 | Arenzano | Italy | 16011 | ||
| 46 | Siena | Italy | 53100 | ||
| 47 | Valeggio Sul Mincio | Italy | 37067 | ||
| 48 | Mexico City | Mexico | 11000 | ||
| 49 | Monterrey | Mexico | 64460 | ||
| 50 | Haugesund | Norway | 5507 | ||
| 51 | Oslo | Norway | 0176 | ||
| 52 | Stavanger | Norway | 4010 | ||
| 53 | Grudziadz | Poland | 86-300 | ||
| 54 | Krakow | Poland | 30-510 | ||
| 55 | Krakow | Poland | 31-501 | ||
| 56 | Cape Town | South Africa | 7500 | ||
| 57 | Pretoria | South Africa | |||
| 58 | Sommerset West | South Africa | 7129 | ||
| 59 | Barcelona | Spain | 08003 | ||
| 60 | Madrid | Spain | 28046 | ||
| 61 | Santander | Spain | 39008 | ||
| 62 | Aberdeen | United Kingdom | AB25 1LD | ||
| 63 | Manchester | United Kingdom | M13 9WL | ||
| 64 | Newcastle Upon Tyne | United Kingdom | NE7 7DN |
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:
NCT00048074
Other Study ID Numbers:
- BM16550
First Posted:
Oct 25, 2002
Last Update Posted:
Feb 3, 2016
Last Verified:
Jan 1, 2016
Study Results
Participant Flow
| Recruitment Details | A total of 1804 participants were screened for the study, from which 1395 participants were enrolled and randomized into treatment with ibandronate. The trial was conducted at 58 centers in 16 countries from June 2002 to May 2005. |
|---|---|
| Pre-assignment Detail | Out of the 1395 participants who were randomized into the study, only 1382 participants received at least one dose of trial treatment and had at least one follow-up assessment as 4 participants did not have safety follow-up and 9 participants did not receive trial treatment. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Period Title: Overall Study | |||
| STARTED | 465 | 448 | 469 |
| COMPLETED | 384 | 361 | 372 |
| NOT COMPLETED | 81 | 87 | 97 |
Baseline Characteristics
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. | Total of all reporting groups |
| Overall Participants | 465 | 448 | 469 | 1382 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
65.7
(6.08)
|
66.6
(6.26)
|
65.8
(6.30)
|
66.0
(6.22)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
465
100%
|
448
100%
|
469
100%
|
1382
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months |
|---|---|
| Description | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline) |
| Time Frame | Baseline and Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 368 | 350 | 359 |
| Mean (Standard Deviation) [Percent Change] |
3.8199
(3.8576)
|
5.0872
(3.8746)
|
4.8188
(3.7613)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ibandronate 2.5mg Daily, Ibandronate 2mg q 2 mo IV |
|---|---|---|
| Comments | The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (2mg q 2 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The IV dosing regimen (2mg q 2 mo IV) 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 | 1.257 | |
| Confidence Interval |
(2-Sided) 95% 0.701 to 1.814 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment effect is the difference in the mean values of the IV regimen (2mg q 2 mo IV) and the active-control. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Ibandronate 2.5mg Daily, Ibandronate 3mg q 3 mo IV |
|---|---|---|
| Comments | The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (3mg q 3 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The IV dosing regimen (3mg q 3 mo IV) 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 | 1.025 | |
| Confidence Interval |
(2-Sided) 95% 0.471 to 1.578 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment effect is the difference in the mean values of the IV regimen (3mg q 3 mo IV) and the active-control. | |
| Title | Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months |
|---|---|
| Description | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline) |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 334 | 320 | 334 |
| Mean (Standard Deviation) [Percent Change] |
4.8412
(4.8654)
|
6.3999
(4.7392)
|
6.2777
(5.0049)
|
| Title | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 |
|---|---|
| Description | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | Baseline, Month 12 and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Month 12, n= 368, 350, 359 |
0.028
(0.0287)
|
0.037
(0.0282)
|
0.035
(0.0269)
|
| Month 24, n= 334, 320, 334 |
0.036
(0.0361)
|
0.047
(0.0347)
|
0.046
(0.0357)
|
| Title | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 |
|---|---|
| Description | BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | Baseline, Month 12 and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Total hip, Month 12, n = 364, 343, 357 |
1.7857
(2.8171)
|
2.5150
(2.6737)
|
2.3604
(3.5156)
|
| Total hip , Month 24, n = 330, 316, 333 |
2.2011
(3.6997)
|
3.3699
(2.9749)
|
3.1279
(4.5422)
|
| Trochanter, Month 12, n = 364, 343, 357 |
2.9721
(4.1651)
|
4.0275
(3.8890)
|
3.8144
(6.0921)
|
| Trochanter, Month 24, n = 330, 316, 333 |
3.4669
(4.7241)
|
5.0428
(4.4640)
|
4.9165
(7.5057)
|
| Femoral neck, Month 12, n = 364, 343, 357 |
1.6129
(4.1050)
|
1.9700
(3.5537)
|
2.3055
(3.9283)
|
| Femoral neck, Month 24, n = 330, 316, 333 |
2.2457
(4.3015)
|
2.7449
(4.1996)
|
2.7849
(4.6723)
|
| Title | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 |
|---|---|
| Description | BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | Baseline, Month 12 and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Total hip, Month 12, n = 364, 343, 357 |
0.013
(0.0202)
|
0.018
(0.0192)
|
0.016
(0.0213)
|
| Total hip, Month 24, n = 330, 316, 333 |
0.015
(0.0259)
|
0.025
(0.0211)
|
0.022
(0.0278)
|
| Trochanter, Month 12, n = 364, 343, 357 |
0.016
(0.0229)
|
0.022
(0.0209)
|
0.020
(0.0250)
|
| Trochanter, Month 24, n = 330, 316, 333 |
0.019
(0.0256)
|
0.029
(0.0242)
|
0.026
(0.0322)
|
| Femoral neck , Month 12, n = 364, 343, 357 |
0.010
(0.0243)
|
0.013
(0.0227)
|
0.014
(0.0240)
|
| Femoral neck , Month 24, n = 330, 316, 333 |
0.014
(0.0258)
|
0.018
(0.0279)
|
0.018
(0.0278)
|
| Title | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 |
|---|---|
| Description | Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed. |
| Time Frame | Baseline, At Month 6, 12, and 24. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Month 6, n = 358, 342, 345 |
-54.715
(30.2820)
|
-55.539
(42.6206)
|
-51.196
(31.0579)
|
| Month 12, n = 360, 342, 347 |
-54.387
(33.2810)
|
-48.042
(95.3711)
|
-49.873
(36.0415)
|
| Month 24, n = 310, 301, 298 |
-51.549
(35.0888)
|
-41.338
(76.8201)
|
-44.325
(38.1338)
|
| Title | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 |
|---|---|
| Description | Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | Baseline, At Month 6, 12, and 24. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Month 6, n = 358, 342, 345 |
-0.318
(0.2550)
|
-0.322
(0.2015)
|
-0.281
(0.2018)
|
| Month 12, n = 360, 342, 347 |
-0.321
(0.2624)
|
-0.318
(0.2239)
|
-0.290
(0.2196)
|
| Month 24, n = 310, 301, 298 |
-0.324
(0.2693)
|
-0.285
(0.2092)
|
-0.276
(0.2323)
|
| Title | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 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. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | At Month 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Above baseline, Month 12, n = 368, 350, 359 |
85.1
18.3%
|
92.3
20.6%
|
91.6
19.5%
|
| Above baseline, Month 24, n = 334, 320, 334 |
84.7
18.2%
|
92.8
20.7%
|
92.8
19.8%
|
| Title | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | At Month 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Above baseline, Month 12, n = 364, 343, 357 |
74.5
16%
|
86.0
19.2%
|
82.6
17.6%
|
| Above baseline, Month 24, n = 330, 316, 333 |
77.0
16.6%
|
88.6
19.8%
|
85.6
18.3%
|
| Title | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | At Month 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Above baseline, Month 12, n = 364, 343, 357 |
76.6
16.5%
|
88.6
19.8%
|
86.3
18.4%
|
| Above baseline, Month 24, n = 330, 316, 333 |
80.0
17.2%
|
92.1
20.6%
|
88.6
18.9%
|
| Title | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24 |
|---|---|
| Description | A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | At Month 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Above baseline, Month 12, n = 364, 343, 357 |
65.1
14%
|
74.1
16.5%
|
70.0
14.9%
|
| Above baseline, Month 24, n = 330, 316, 333 |
67.6
14.5%
|
77.5
17.3%
|
76.6
16.3%
|
| Title | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 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. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | At Month 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Above baseline, Month 12, n = 363, 343, 355 |
66.9
14.4%
|
80.5
18%
|
76.3
16.3%
|
| Above baseline, Month 24, n = 330, 314, 332 |
68.8
14.8%
|
83.1
18.5%
|
80.1
17.1%
|
| Title | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 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. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | At Month 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Above baseline, Month 12, n = 363, 343, 355 |
68.0
14.6%
|
83.4
18.6%
|
79.7
17%
|
| Above baseline, Month 24, n = 330, 314, 332 |
70.9
15.2%
|
85.7
19.1%
|
83.1
17.7%
|
| Title | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 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. Only participants with data available at particular timepoint were analyzed. |
| Time Frame | At Month 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 375 | 350 | 364 |
| Above baseline, Month 12, n = 363, 343, 355 |
58.4
12.6%
|
69.4
15.5%
|
64.5
13.8%
|
| Above baseline, Month 24, n = 330, 314, 332 |
59.7
12.8%
|
72.3
16.1%
|
71.7
15.3%
|
| Title | Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs) |
|---|---|
| Description | An 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 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 | Approximately 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: All 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 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 465 | 448 | 469 |
| Any AE |
408
87.7%
|
397
88.6%
|
400
85.3%
|
| Any SAE |
67
14.4%
|
73
16.3%
|
62
13.2%
|
| Title | Number of Participants With Any Marked Abnormality in Laboratory Parameters |
|---|---|
| Description | Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 * 10^9/L), low and high white blood cell (WBC) (3.0 - 18.0 * 10^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L). |
| Time Frame | Approximately 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: All 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. Only participants with data available for the indicated laboratory abnormality were analyzed. |
| Arm/Group Title | Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. |
| Measure Participants | 465 | 448 | 469 |
| Hematocrit - High, n = 453, 433, 456 |
0
0%
|
0
0%
|
1
0.2%
|
| Hematocrit - low, n = 453, 433, 456 |
0
0%
|
2
0.4%
|
5
1.1%
|
| Hemoglobin - High, n = 453, 433, 456 |
0
0%
|
1
0.2%
|
1
0.2%
|
| Hemoglobin - Low n = 453, 433, 456 |
2
0.4%
|
5
1.1%
|
5
1.1%
|
| Platelets - High, n = 452, 431, 455 |
0
0%
|
2
0.4%
|
1
0.2%
|
| Platelets - Low, n = 452, 431, 455 |
2
0.4%
|
0
0%
|
1
0.2%
|
| WBC - High, n = 453, 433, 456 |
0
0%
|
1
0.2%
|
2
0.4%
|
| WBC - Low, n = 453, 433, 456 |
4
0.9%
|
4
0.9%
|
2
0.4%
|
| ALAT (SGPT) - High, n = 453, 434, 456 |
13
2.8%
|
12
2.7%
|
18
3.8%
|
| BUN - High, n = 453, 434, 456 |
1
0.2%
|
2
0.4%
|
0
0%
|
| Creatinine - High, n = 453, 434, 456 |
0
0%
|
2
0.4%
|
0
0%
|
| Albumin - Low, n = 453, 434, 456 |
0
0%
|
1
0.2%
|
0
0%
|
| Chloride - High, n = 453, 433, 456 |
1
0.2%
|
0
0%
|
0
0%
|
| Chloride - Low, n = 453, 433, 456 |
4
0.9%
|
3
0.7%
|
3
0.6%
|
| Potassium - Low, n = 453, 433, 456 |
0
0%
|
1
0.2%
|
0
0%
|
| Sodium - Low, n = 453, 433, 456 |
0
0%
|
1
0.2%
|
1
0.2%
|
| Calcium - High, n = 453, 434, 456 |
0
0%
|
1
0.2%
|
0
0%
|
| Phosphate - High, n = 453, 434, 456 |
7
1.5%
|
4
0.9%
|
6
1.3%
|
| Phosphate - Low, n = 453, 434, 456 |
6
1.3%
|
3
0.7%
|
2
0.4%
|
Adverse Events
| Time Frame | Approximately 2 years | |||||
|---|---|---|---|---|---|---|
| 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 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV | |||
| Arm/Group Description | Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months. | Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months. | Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months. | |||
All Cause Mortality |
||||||
| Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 67/465 (14.4%) | 73/448 (16.3%) | 62/469 (13.2%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Cardiac disorders | ||||||
| Myocardial infarction | 1/465 (0.2%) | 4/448 (0.9%) | 2/469 (0.4%) | |||
| Angina pectoris | 1/465 (0.2%) | 1/448 (0.2%) | 2/469 (0.4%) | |||
| Acute myocardial infarction | 1/465 (0.2%) | 0/448 (0%) | 2/469 (0.4%) | |||
| Arrhythmia | 0/465 (0%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Atrial fibrillation | 0/465 (0%) | 2/448 (0.4%) | 0/469 (0%) | |||
| Cardiac failure | 0/465 (0%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Myocardial ischaemia | 1/465 (0.2%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Angina unstable | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Atrial flutter | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Cardiovascular disorder | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Coronary artery disease | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Mitral valve disease | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Sick sinus syndrome | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Tricuspid valve incompetence | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Ventricular arrhythmia | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vestibular neuronitis | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Endocrine disorders | ||||||
| Goitre | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Hyperparathyroidism primary | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Toxic nodular goitre | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Eye disorders | ||||||
| Cataract | 0/465 (0%) | 1/448 (0.2%) | 2/469 (0.4%) | |||
| Iridocyclitis | 2/465 (0.4%) | 0/448 (0%) | 0/469 (0%) | |||
| Hypotony of eye | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Open angle glaucoma | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Retinal artery thrombosis | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Retinal degeneration | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Gastrointestinal disorders | ||||||
| Gastric ulcer | 0/465 (0%) | 2/448 (0.4%) | 1/469 (0.2%) | |||
| Gastritis | 1/465 (0.2%) | 0/448 (0%) | 2/469 (0.4%) | |||
| Colonic stenosis | 0/465 (0%) | 2/448 (0.4%) | 0/469 (0%) | |||
| Diverticulum intestinal | 1/465 (0.2%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Gastrointestinal haemorrhage | 0/465 (0%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Pancreatitis acute | 1/465 (0.2%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Rectocele | 0/465 (0%) | 2/448 (0.4%) | 0/469 (0%) | |||
| Abdominal pain | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Diarrhoea | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Diverticulum | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Duodenal ulcer haemorrhage | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Gastrointestinal ulcer haemorrhage | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Gastrooesophageal reflux disease | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Intestinal perforation | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Melaena | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Oesophageal ulcer | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Small intestinal perforation | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Subileus | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| General disorders | ||||||
| Oedema peripheral | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Pyrexia | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Hepatobiliary disorders | ||||||
| Cholelithiasis | 2/465 (0.4%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Bile duct stone | 2/465 (0.4%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Cholecystitis chronic | 2/465 (0.4%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Cholecystitis | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Immune system disorders | ||||||
| Drug hypersensitivity | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Sarcoidosis | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Infections and infestations | ||||||
| Abscess limb | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Bronchopneumonia | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Diverticulitis | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Furuncle | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Klebsiella bacteraemia | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Periorbital cellulitis | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Pneumonia | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Postoperative infection | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Pyelonephritis acute | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Sinusitis | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Tuberculosis | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Urinary tract infection | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Urosepsis | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Injury, poisoning and procedural complications | ||||||
| Ankle fracture | 2/465 (0.4%) | 3/448 (0.7%) | 1/469 (0.2%) | |||
| Femoral neck fracture | 2/465 (0.4%) | 0/448 (0%) | 0/469 (0%) | |||
| Joint dislocation | 0/465 (0%) | 0/448 (0%) | 2/469 (0.4%) | |||
| Radius fracture | 2/465 (0.4%) | 0/448 (0%) | 0/469 (0%) | |||
| Spinal compression fracture | 0/465 (0%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Wrist fracture | 2/465 (0.4%) | 0/448 (0%) | 0/469 (0%) | |||
| Drug toxicity | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Extradural haematoma | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Femur fracture | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Foot fracture | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Forearm fracture | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Hip fracture | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Incisional hernia | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Lumbar vertebral fracture | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Meniscus lesion | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Muscle injury | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Pelvic fracture | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Postoperative constipation | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Radiation injury | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Tendon rupture | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Thoracic vertebral fracture | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Tibia fracture | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Vascular graft occlusion | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Wound dehiscence | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Investigations | ||||||
| Hepatic enzyme increased | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| International normalised ratio increased | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Red blood cell sedimentation rate increased | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Diabetes mellitus | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Diabetes mellitus non-insulin-dependent | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Osteoarthritis | 2/465 (0.4%) | 3/448 (0.7%) | 0/469 (0%) | |||
| Back pain | 0/465 (0%) | 2/448 (0.4%) | 0/469 (0%) | |||
| Intervertebral disc protrusion | 0/465 (0%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Musculoskeletal chest pain | 1/465 (0.2%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Bunion | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Dupuytren's contracture | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Polymyalgia rheumatica | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Spinal osteoarthritis | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Breast cancer | 2/465 (0.4%) | 2/448 (0.4%) | 1/469 (0.2%) | |||
| Colon cancer | 1/465 (0.2%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Basal cell carcinoma | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Benign neoplasm of thyroid gland | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Bladder cancer | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Breast neoplasm | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Colon adenoma | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Colon cancer metastatic | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Diffuse large B-cell lymphoma | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Gallbladder cancer | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Lung adenocarcinoma | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Lung neoplasm malignant | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Malignant melanoma | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Myelofibrosis | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Neuroma | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Non-hodgkin's lymphoma | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Oesophageal squamous cell carcinoma | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Ovarian adenoma | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Ovarian cancer metastatic | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Renal neoplasm | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Small cell lung cancer stage unspecified | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Nervous system disorders | ||||||
| Cerebrovascular accident | 1/465 (0.2%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Transient ischaemic attack | 0/465 (0%) | 1/448 (0.2%) | 2/469 (0.4%) | |||
| Cerebral infarction | 0/465 (0%) | 0/448 (0%) | 2/469 (0.4%) | |||
| Sciatica | 0/465 (0%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Syncope | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Cerebellar syndrome | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Cerebral circulatory failure | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Cerebral haemorrhage | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Cerebrovascular insufficiency | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Dementia | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Dizziness | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Epilepsy | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Grand mal convulsion | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Loss of consciousness | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Migraine | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Paraparesis | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Reversible ischaemic neurological deficit | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Spinal vascular disorder | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Temporal lobe epilepsy | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Histrionic personality disorder | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Suicide attempt | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Renal and urinary disorders | ||||||
| Cystocele | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Diabetic nephropathy | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Nephrolithiasis | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Stress incontinence | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Urinary incontinence | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Ovarian cyst | 3/465 (0.6%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Uterine prolapse | 0/465 (0%) | 2/448 (0.4%) | 0/469 (0%) | |||
| Vaginal prolapse | 0/465 (0%) | 1/448 (0.2%) | 1/469 (0.2%) | |||
| Fallopian tube cyst | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Vaginal pain | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 0/465 (0%) | 3/448 (0.7%) | 1/469 (0.2%) | |||
| Chronic obstructive pulmonary disease | 2/465 (0.4%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Pulmonary embolism | 1/465 (0.2%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Acute respiratory distress syndrome | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Cough | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Lung infiltration | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Nasal polyps | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Pulmonary hypertension | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Pulmonary oedema | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Pulmonary thrombosis | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Upper respiratory tract inflammation | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Angioneurotic oedema | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Hyperkeratosis | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Vascular disorders | ||||||
| Arterial occlusive disease | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Arteriosclerosis | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Femoral artery occlusion | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Hypertensive crisis | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Hypotension | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Peripheral ischaemia | 0/465 (0%) | 1/448 (0.2%) | 0/469 (0%) | |||
| Temporal arteritis | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
| Varicose vein | 0/465 (0%) | 0/448 (0%) | 1/469 (0.2%) | |||
| Venous insufficiency | 1/465 (0.2%) | 0/448 (0%) | 0/469 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Ibandronate 2.5mg Daily | Ibandronate 2mg q 2 mo IV | Ibandronate 3mg q 3 mo IV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 301/465 (64.7%) | 316/448 (70.5%) | 284/469 (60.6%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain upper | 33/465 (7.1%) | 24/448 (5.4%) | 29/469 (6.2%) | |||
| Dyspepsia | 28/465 (6%) | 28/448 (6.3%) | 23/469 (4.9%) | |||
| Constipation | 27/465 (5.8%) | 33/448 (7.4%) | 18/469 (3.8%) | |||
| Diarrhoea | 18/465 (3.9%) | 23/448 (5.1%) | 20/469 (4.3%) | |||
| Nausea | 25/465 (5.4%) | 22/448 (4.9%) | 13/469 (2.8%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 65/465 (14%) | 66/448 (14.7%) | 43/469 (9.2%) | |||
| Influenza | 51/465 (11%) | 43/448 (9.6%) | 35/469 (7.5%) | |||
| Bronchitis | 23/465 (4.9%) | 28/448 (6.3%) | 22/469 (4.7%) | |||
| Urinary tract infection | 28/465 (6%) | 24/448 (5.4%) | 18/469 (3.8%) | |||
| Gastroenteritis | 24/465 (5.2%) | 19/448 (4.2%) | 12/469 (2.6%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypercholesterolaemia | 32/465 (6.9%) | 29/448 (6.5%) | 19/469 (4.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 56/465 (12%) | 62/448 (13.8%) | 58/469 (12.4%) | |||
| Arthralgia | 50/465 (10.8%) | 55/448 (12.3%) | 56/469 (11.9%) | |||
| Osteoarthritis | 19/465 (4.1%) | 26/448 (5.8%) | 30/469 (6.4%) | |||
| Pain in extremity | 16/465 (3.4%) | 27/448 (6%) | 18/469 (3.8%) | |||
| Bone pain | 8/465 (1.7%) | 23/448 (5.1%) | 11/469 (2.3%) | |||
| Nervous system disorders | ||||||
| Headache | 21/465 (4.5%) | 27/448 (6%) | 21/469 (4.5%) | |||
| Vascular disorders | ||||||
| Hypertension | 54/465 (11.6%) | 44/448 (9.8%) | 47/469 (10%) | |||
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:
NCT00048074
Other Study ID Numbers:
- BM16550
First Posted:
Oct 25, 2002
Last Update Posted:
Feb 3, 2016
Last Verified:
Jan 1, 2016