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DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

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ClinicalTrials.gov Identifier: NCT00048074
Recruitment Status : Completed
First Posted : October 25, 2002
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Post Menopausal Osteoporosis
Intervention Drug: ibandronate [Bonviva/Boniva]
Enrollment 1395

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 Details 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
Hide 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
Reason Not Completed
Adverse Event             46             41             53
Death             3             3             2
Lost to Follow-up             2             6             6
Withdrawal by Subject             28             30             35
Protocol Violation             1             3             0
Study participation was terminated             0             1             0
Husband ill             0             1             0
Poor compliance             0             1             0
Out of station             0             1             1
Social reasons             1             0             0
Arm/Group Title Ibandronate 2.5mg Daily Ibandronate 2mg q 2 mo IV Ibandronate 3mg q 3 mo IV Total
Hide 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 Number of Baseline Participants 465 448 469 1382
Hide Baseline 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 were included.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 465 participants 448 participants 469 participants 1382 participants
65.7  (6.08) 66.6  (6.26) 65.8  (6.30) 66.0  (6.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 465 participants 448 participants 469 participants 1382 participants
Female
465
 100.0%
448
 100.0%
469
 100.0%
1382
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 368 350 359
Mean (Standard Deviation)
Unit of Measure: Percent Change
3.8199  (3.8576) 5.0872  (3.8746) 4.8188  (3.7613)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.257
Confidence Interval (2-Sided) 95%
0.701 to 1.814
Estimation Comments Treatment effect is the difference in the mean values of the IV regimen (2mg q 2 mo IV) and the active-control.
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.025
Confidence Interval (2-Sided) 95%
0.471 to 1.578
Estimation Comments Treatment effect is the difference in the mean values of the IV regimen (3mg q 3 mo IV) and the active-control.
2.Secondary Outcome
Title Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 334 320 334
Mean (Standard Deviation)
Unit of Measure: Percent Change
4.8412  (4.8654) 6.3999  (4.7392) 6.2777  (5.0049)
3.Secondary Outcome
Title Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 – L4) at Month 12 and Month 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Mean (Standard Deviation)
Unit of Measure: Absolute Change (g/cm^2)
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)
4.Secondary Outcome
Title Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Mean (Standard Deviation)
Unit of Measure: Percent Change
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)
5.Secondary Outcome
Title Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Mean (Standard Deviation)
Unit of Measure: Absolute Change (g/cm^2)
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)
6.Secondary Outcome
Title Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Mean (Standard Deviation)
Unit of Measure: Percent Change
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)
7.Secondary Outcome
Title Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Mean (Standard Deviation)
Unit of Measure: Absolute Change (ng/mL)
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)
8.Secondary Outcome
Title Percentage of Participants With Mean Lumbar Spine (L2 – L4) BMD Above or Equal to Baseline at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Measure Type: Number
Unit of Measure: Percentage of participants
Above baseline, Month 12, n = 368, 350, 359 85.1 92.3 91.6
Above baseline, Month 24, n = 334, 320, 334 84.7 92.8 92.8
9.Secondary Outcome
Title Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Measure Type: Number
Unit of Measure: Percentage of participants
Above baseline, Month 12, n = 364, 343, 357 74.5 86.0 82.6
Above baseline, Month 24, n = 330, 316, 333 77.0 88.6 85.6
10.Secondary Outcome
Title Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Measure Type: Number
Unit of Measure: Percentage of participants
Above baseline, Month 12, n = 364, 343, 357 76.6 88.6 86.3
Above baseline, Month 24, n = 330, 316, 333 80.0 92.1 88.6
11.Secondary Outcome
Title Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Measure Type: Number
Unit of Measure: Percentage of participants
Above baseline, Month 12, n = 364, 343, 357 65.1 74.1 70.0
Above baseline, Month 24, n = 330, 316, 333 67.6 77.5 76.6
12.Secondary Outcome
Title Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Measure Type: Number
Unit of Measure: Percentage of participants
Above baseline, Month 12, n = 363, 343, 355 66.9 80.5 76.3
Above baseline, Month 24, n = 330, 314, 332 68.8 83.1 80.1
13.Secondary Outcome
Title Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Measure Type: Number
Unit of Measure: Percentage of participants
Above baseline, Month 12, n = 363, 343, 355 68.0 83.4 79.7
Above baseline, Month 24, n = 330, 314, 332 70.9 85.7 83.1
14.Secondary Outcome
Title Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 375 350 364
Measure Type: Number
Unit of Measure: Percentage of participants
Above baseline, Month 12, n = 363, 343, 355 58.4 69.4 64.5
Above baseline, Month 24, n = 330, 314, 332 59.7 72.3 71.7
15.Secondary Outcome
Title Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 465 448 469
Measure Type: Number
Unit of Measure: participants
Any AE 408 397 400
Any SAE 67 73 62
16.Secondary Outcome
Title Number of Participants With Any Marked Abnormality in Laboratory Parameters
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 465 448 469
Measure Type: Number
Unit of Measure: participants
Hematocrit - High, n = 453, 433, 456 0 0 1
Hematocrit - low, n = 453, 433, 456 0 2 5
Hemoglobin - High, n = 453, 433, 456 0 1 1
Hemoglobin - Low n = 453, 433, 456 2 5 5
Platelets - High, n = 452, 431, 455 0 2 1
Platelets - Low, n = 452, 431, 455 2 0 1
WBC - High, n = 453, 433, 456 0 1 2
WBC - Low, n = 453, 433, 456 4 4 2
ALAT (SGPT) - High, n = 453, 434, 456 13 12 18
BUN - High, n = 453, 434, 456 1 2 0
Creatinine - High, n = 453, 434, 456 0 2 0
Albumin - Low, n = 453, 434, 456 0 1 0
Chloride – High, n = 453, 433, 456 1 0 0
Chloride – Low, n = 453, 433, 456 4 3 3
Potassium – Low, n = 453, 433, 456 0 1 0
Sodium – Low, n = 453, 433, 456 0 1 1
Calcium – High, n = 453, 434, 456 0 1 0
Phosphate - High, n = 453, 434, 456 7 4 6
Phosphate - Low, n = 453, 434, 456 6 3 2
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ibandronate 2.5mg Daily Ibandronate 2mg q 2 mo IV Ibandronate 3mg q 3 mo IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   67/465 (14.41%)   73/448 (16.29%)   62/469 (13.22%) 
Blood and lymphatic system disorders       
Anaemia  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Cardiac disorders       
Myocardial infarction  1  1/465 (0.22%)  4/448 (0.89%)  2/469 (0.43%) 
Angina pectoris  1  1/465 (0.22%)  1/448 (0.22%)  2/469 (0.43%) 
Acute myocardial infarction  1  1/465 (0.22%)  0/448 (0.00%)  2/469 (0.43%) 
Arrhythmia  1  0/465 (0.00%)  1/448 (0.22%)  1/469 (0.21%) 
Atrial fibrillation  1  0/465 (0.00%)  2/448 (0.45%)  0/469 (0.00%) 
Cardiac failure  1  0/465 (0.00%)  1/448 (0.22%)  1/469 (0.21%) 
Myocardial ischaemia  1  1/465 (0.22%)  1/448 (0.22%)  0/469 (0.00%) 
Angina unstable  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Atrial flutter  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Cardiovascular disorder  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Coronary artery disease  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Mitral valve disease  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Sick sinus syndrome  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Tricuspid valve incompetence  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Ventricular arrhythmia  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Ear and labyrinth disorders       
Vestibular neuronitis  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Endocrine disorders       
Goitre  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Hyperparathyroidism primary  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Toxic nodular goitre  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Eye disorders       
Cataract  1  0/465 (0.00%)  1/448 (0.22%)  2/469 (0.43%) 
Iridocyclitis  1  2/465 (0.43%)  0/448 (0.00%)  0/469 (0.00%) 
Hypotony of eye  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Open angle glaucoma  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Retinal artery thrombosis  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Retinal degeneration  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Gastrointestinal disorders       
Gastric ulcer  1  0/465 (0.00%)  2/448 (0.45%)  1/469 (0.21%) 
Gastritis  1  1/465 (0.22%)  0/448 (0.00%)  2/469 (0.43%) 
Colonic stenosis  1  0/465 (0.00%)  2/448 (0.45%)  0/469 (0.00%) 
Diverticulum intestinal  1  1/465 (0.22%)  1/448 (0.22%)  0/469 (0.00%) 
Gastrointestinal haemorrhage  1  0/465 (0.00%)  1/448 (0.22%)  1/469 (0.21%) 
Pancreatitis acute  1  1/465 (0.22%)  1/448 (0.22%)  0/469 (0.00%) 
Rectocele  1  0/465 (0.00%)  2/448 (0.45%)  0/469 (0.00%) 
Abdominal pain  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Diarrhoea  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Diverticulum  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Duodenal ulcer haemorrhage  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Gastrointestinal ulcer haemorrhage  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Gastrooesophageal reflux disease  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Intestinal perforation  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Melaena  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Oesophageal ulcer  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Small intestinal perforation  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Subileus  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
General disorders       
Oedema peripheral  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Pyrexia  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis  1  2/465 (0.43%)  1/448 (0.22%)  1/469 (0.21%) 
Bile duct stone  1  2/465 (0.43%)  0/448 (0.00%)  1/469 (0.21%) 
Cholecystitis chronic  1  2/465 (0.43%)  0/448 (0.00%)  1/469 (0.21%) 
Cholecystitis  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Immune system disorders       
Drug hypersensitivity  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Sarcoidosis  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Infections and infestations       
Abscess limb  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Bronchopneumonia  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Diverticulitis  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Furuncle  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Klebsiella bacteraemia  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Periorbital cellulitis  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Pneumonia  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Postoperative infection  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Pyelonephritis acute  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Sinusitis  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Tuberculosis  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Urinary tract infection  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Urosepsis  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  2/465 (0.43%)  3/448 (0.67%)  1/469 (0.21%) 
Femoral neck fracture  1  2/465 (0.43%)  0/448 (0.00%)  0/469 (0.00%) 
Joint dislocation  1  0/465 (0.00%)  0/448 (0.00%)  2/469 (0.43%) 
Radius fracture  1  2/465 (0.43%)  0/448 (0.00%)  0/469 (0.00%) 
Spinal compression fracture  1  0/465 (0.00%)  1/448 (0.22%)  1/469 (0.21%) 
Wrist fracture  1  2/465 (0.43%)  0/448 (0.00%)  0/469 (0.00%) 
Drug toxicity  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Extradural haematoma  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Femur fracture  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Foot fracture  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Forearm fracture  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Hip fracture  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Incisional hernia  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Lumbar vertebral fracture  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Meniscus lesion  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Muscle injury  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Pelvic fracture  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Postoperative constipation  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Radiation injury  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Tendon rupture  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Thoracic vertebral fracture  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Tibia fracture  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Vascular graft occlusion  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Wound dehiscence  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Investigations       
Hepatic enzyme increased  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
International normalised ratio increased  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Red blood cell sedimentation rate increased  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Metabolism and nutrition disorders       
Dehydration  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Diabetes mellitus  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Diabetes mellitus non-insulin-dependent  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  2/465 (0.43%)  3/448 (0.67%)  0/469 (0.00%) 
Back pain  1  0/465 (0.00%)  2/448 (0.45%)  0/469 (0.00%) 
Intervertebral disc protrusion  1  0/465 (0.00%)  1/448 (0.22%)  1/469 (0.21%) 
Musculoskeletal chest pain  1  1/465 (0.22%)  1/448 (0.22%)  0/469 (0.00%) 
Bunion  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Dupuytren's contracture  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Polymyalgia rheumatica  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Spinal osteoarthritis  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  2/465 (0.43%)  2/448 (0.45%)  1/469 (0.21%) 
Colon cancer  1  1/465 (0.22%)  1/448 (0.22%)  0/469 (0.00%) 
Basal cell carcinoma  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Benign neoplasm of thyroid gland  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Bladder cancer  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Breast neoplasm  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Colon adenoma  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Colon cancer metastatic  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Diffuse large B-cell lymphoma  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Gallbladder cancer  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Lung adenocarcinoma  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Lung neoplasm malignant  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Malignant melanoma  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Myelofibrosis  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Neuroma  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Non-hodgkin's lymphoma  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Oesophageal squamous cell carcinoma  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Ovarian adenoma  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Ovarian cancer metastatic  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Renal neoplasm  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Small cell lung cancer stage unspecified  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Nervous system disorders       
Cerebrovascular accident  1  1/465 (0.22%)  1/448 (0.22%)  1/469 (0.21%) 
Transient ischaemic attack  1  0/465 (0.00%)  1/448 (0.22%)  2/469 (0.43%) 
Cerebral infarction  1  0/465 (0.00%)  0/448 (0.00%)  2/469 (0.43%) 
Sciatica  1  0/465 (0.00%)  1/448 (0.22%)  1/469 (0.21%) 
Syncope  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Cerebellar syndrome  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Cerebral circulatory failure  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Cerebral haemorrhage  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Cerebrovascular insufficiency  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Dementia  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Dizziness  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Epilepsy  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Grand mal convulsion  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Loss of consciousness  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Migraine  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Paraparesis  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Reversible ischaemic neurological deficit  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Spinal vascular disorder  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Temporal lobe epilepsy  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Psychiatric disorders       
Anxiety  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Histrionic personality disorder  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Suicide attempt  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Renal and urinary disorders       
Cystocele  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Diabetic nephropathy  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Nephrolithiasis  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Stress incontinence  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Urinary incontinence  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst  1  3/465 (0.65%)  0/448 (0.00%)  1/469 (0.21%) 
Uterine prolapse  1  0/465 (0.00%)  2/448 (0.45%)  0/469 (0.00%) 
Vaginal prolapse  1  0/465 (0.00%)  1/448 (0.22%)  1/469 (0.21%) 
Fallopian tube cyst  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Vaginal pain  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/465 (0.00%)  3/448 (0.67%)  1/469 (0.21%) 
Chronic obstructive pulmonary disease  1  2/465 (0.43%)  1/448 (0.22%)  0/469 (0.00%) 
Pulmonary embolism  1  1/465 (0.22%)  1/448 (0.22%)  0/469 (0.00%) 
Acute respiratory distress syndrome  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Cough  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Lung infiltration  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Nasal polyps  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Pulmonary hypertension  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Pulmonary oedema  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Pulmonary thrombosis  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Upper respiratory tract inflammation  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Skin and subcutaneous tissue disorders       
Angioneurotic oedema  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Hyperkeratosis  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Vascular disorders       
Arterial occlusive disease  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Arteriosclerosis  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Femoral artery occlusion  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Hypertensive crisis  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Hypotension  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Peripheral ischaemia  1  0/465 (0.00%)  1/448 (0.22%)  0/469 (0.00%) 
Temporal arteritis  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Varicose vein  1  0/465 (0.00%)  0/448 (0.00%)  1/469 (0.21%) 
Venous insufficiency  1  1/465 (0.22%)  0/448 (0.00%)  0/469 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibandronate 2.5mg Daily Ibandronate 2mg q 2 mo IV Ibandronate 3mg q 3 mo IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   301/465 (64.73%)   316/448 (70.54%)   284/469 (60.55%) 
Gastrointestinal disorders       
Abdominal pain upper  1  33/465 (7.10%)  24/448 (5.36%)  29/469 (6.18%) 
Dyspepsia  1  28/465 (6.02%)  28/448 (6.25%)  23/469 (4.90%) 
Constipation  1  27/465 (5.81%)  33/448 (7.37%)  18/469 (3.84%) 
Diarrhoea  1  18/465 (3.87%)  23/448 (5.13%)  20/469 (4.26%) 
Nausea  1  25/465 (5.38%)  22/448 (4.91%)  13/469 (2.77%) 
Infections and infestations       
Nasopharyngitis  1  65/465 (13.98%)  66/448 (14.73%)  43/469 (9.17%) 
Influenza  1  51/465 (10.97%)  43/448 (9.60%)  35/469 (7.46%) 
Bronchitis  1  23/465 (4.95%)  28/448 (6.25%)  22/469 (4.69%) 
Urinary tract infection  1  28/465 (6.02%)  24/448 (5.36%)  18/469 (3.84%) 
Gastroenteritis  1  24/465 (5.16%)  19/448 (4.24%)  12/469 (2.56%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  32/465 (6.88%)  29/448 (6.47%)  19/469 (4.05%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  56/465 (12.04%)  62/448 (13.84%)  58/469 (12.37%) 
Arthralgia  1  50/465 (10.75%)  55/448 (12.28%)  56/469 (11.94%) 
Osteoarthritis  1  19/465 (4.09%)  26/448 (5.80%)  30/469 (6.40%) 
Pain in extremity  1  16/465 (3.44%)  27/448 (6.03%)  18/469 (3.84%) 
Bone pain  1  8/465 (1.72%)  23/448 (5.13%)  11/469 (2.35%) 
Nervous system disorders       
Headache  1  21/465 (4.52%)  27/448 (6.03%)  21/469 (4.48%) 
Vascular disorders       
Hypertension  1  54/465 (11.61%)  44/448 (9.82%)  47/469 (10.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048074     History of Changes
Other Study ID Numbers: BM16550
First Submitted: October 24, 2002
First Posted: October 25, 2002
Results First Submitted: January 4, 2016
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016