Trial Outcomes & Findings for Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma (NCT NCT02739594)
NCT ID: NCT02739594
Last Updated: 2016-07-22
Results Overview
CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
89 participants
Primary outcome timeframe
Baseline, Week 44
Results posted on
2016-07-22
Participant Flow
Participant milestones
| Measure |
Ibandronate
Participants with multiple myeloma received ibandronate via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
43
|
|
Overall Study
Completed at Week 44
|
11
|
5
|
|
Overall Study
Completed at Week 96
|
10
|
10
|
|
Overall Study
COMPLETED
|
21
|
15
|
|
Overall Study
NOT COMPLETED
|
25
|
28
|
Reasons for withdrawal
| Measure |
Ibandronate
Participants with multiple myeloma received ibandronate via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Overall Study
Undesired Event
|
3
|
4
|
|
Overall Study
Violation of Eligibility Criteria
|
1
|
2
|
|
Overall Study
Protocol Violation
|
5
|
6
|
|
Overall Study
Death
|
4
|
2
|
|
Overall Study
Renal Insufficiency
|
4
|
6
|
|
Overall Study
Administrative Reasons
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Elevated Serum Creatinine
|
0
|
1
|
|
Overall Study
Other
|
6
|
2
|
Baseline Characteristics
Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 44Population: Intent-to-Treat (ITT) Population.
CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44
|
9.8 percentage of participants
Interval 2.7 to 23.1
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
PRIMARY outcome
Timeframe: Baseline, Week 92Population: ITT Population.
CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30% from Baseline or an absolute value ≤30 mL/min at Week 92. The last available value on/before Week 92 was used in the calculation. The percentage of participants with deterioration in renal function at Week 92 was reported.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92
|
14.6 percentage of participants
Interval 5.6 to 29.2
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
SECONDARY outcome
Timeframe: From Baseline to end of study (up to Week 96)Population: ITT Population.
SREs were defined according to the Bondronat Summary of Product Characteristics (SmPC) to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The percentage of participants with at least 1 SRE during the study was reported.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percentage of Participants With Skeletal-Related Events (SREs)
|
22.0 percentage of participants
Interval 10.6 to 37.6
|
30.0 percentage of participants
Interval 16.6 to 46.5
|
SECONDARY outcome
Timeframe: From Baseline to end of study (up to Week 96)Population: ITT Population.
SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. Time to first SRE was defined as the time from first dose of study drug to the time of SRE during the study. The median time to first SRE was estimated by Kaplan-Meier analysis and expressed in days.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Time to First SRE
|
393.0 days
Interval 12.0 to 727.0
|
244.5 days
Interval 21.0 to 693.0
|
SECONDARY outcome
Timeframe: From Baseline to end of study (up to Week 96)Population: ITT Population.
SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The number of SREs was averaged across all participants, including those participants who did not experience SREs during the study.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Number of SREs for Each Participant
|
0.3 SREs
Standard Deviation 0.6
|
0.5 SREs
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: From Baseline to end of study (up to Week 96)Population: ITT Population.
The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percentage of Participants With Osteonecrosis of Jaw
|
0.0 percentage of participants
Interval 0.0 to 8.6
|
0.0 percentage of participants
Interval 0.0 to 8.8
|
SECONDARY outcome
Timeframe: From Baseline to end of study (up to Week 96)Population: ITT Population.
The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Number of Events of Osteonecrosis of Jaw for Each Participant
|
0.0 events of osteonecrosis of jaw
Standard Deviation 0.0
|
0.0 events of osteonecrosis of jaw
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: From Baseline to end of study (up to Week 96)Population: ITT Population; only the Zoledronate arm was included.
The percentage of participants with at least 1 zoledronate dose reduction during the study was reported.
Outcome measures
| Measure |
Ibandronate
n=40 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percentage of Participants With Zoledronate Dose Reduction
|
30.0 percentage of participants
Interval 16.6 to 46.5
|
—
|
SECONDARY outcome
Timeframe: From Baseline to end of study (up to Week 96)Population: ITT Population; only the Zoledronate arm was included.
The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study.
Outcome measures
| Measure |
Ibandronate
n=40 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Number of Zoledronate Dose Reductions for Each Participant
|
0.8 dose reductions
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44, 92Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.
The percent change in B-NAG was calculated as \[Week 44 or 92 B-NAG minus Baseline B-NAG\] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Outcome measures
| Measure |
Ibandronate
n=38 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=37 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)
Week 44
|
-15.7 percent change
Interval -86.0 to 355.0
|
10.6 percent change
Interval -94.0 to 156.0
|
|
Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)
Week 92
|
-17.2 percent change
Interval -78.0 to 355.0
|
9.3 percent change
Interval -94.0 to 125.0
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44, 92Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.
The percent change in A1-microglobulin was calculated as \[Week 44 or 92 A1-microglobulin minus Baseline A1-microglobulin\] divided by Baseline A1-microglobulin, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Outcome measures
| Measure |
Ibandronate
n=38 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=37 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percent Change From Baseline in Alpha (A) 1-Microglobulin
Week 44
|
0.0 percent change
Interval -85.0 to 706.0
|
0.0 percent change
Interval -86.0 to 429.0
|
|
Percent Change From Baseline in Alpha (A) 1-Microglobulin
Week 92
|
0.0 percent change
Interval -85.0 to 706.0
|
0.0 percent change
Interval -86.0 to 591.0
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44, 92Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.
The percent change in GGT was calculated as \[Week 44 or 92 GGT minus Baseline GGT\] divided by Baseline GGT, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Outcome measures
| Measure |
Ibandronate
n=38 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=37 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)
Week 44
|
-6.0 percent change
Interval -57.0 to 393.0
|
3.8 percent change
Interval -66.0 to 50.0
|
|
Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)
Week 92
|
-2.5 percent change
Interval -57.0 to 393.0
|
3.8 percent change
Interval -66.0 to 61.0
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44, 92Population: ITT Population.
Elevation in SCr was defined as an increase greater than (\>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (\<) 1.4 mg/dL, or an increase \>1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
Week 44
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
|
Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
Week 92
|
7.3 percentage of participants
Interval 1.5 to 19.9
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44, 92Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who provided data within the specified timeframe for each analysis (n) is shown in the table.
CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as \[Week 44 or 92 CrCl minus Baseline CrCl\] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Outcome measures
| Measure |
Ibandronate
n=41 Participants
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=40 Participants
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Percent Change From Baseline in CrCl
Week 44, Calculated/Blood (n=41,40)
|
-0.5 percent change
Standard Deviation 28.5
|
-0.4 percent change
Standard Deviation 21.7
|
|
Percent Change From Baseline in CrCl
Week 44, Measured/Urinalysis (n=37,37)
|
6.9 percent change
Standard Deviation 53.0
|
3.9 percent change
Standard Deviation 37.3
|
|
Percent Change From Baseline in CrCl
Week 92, Calculated/Blood (n=41,40)
|
-0.7 percent change
Standard Deviation 31.9
|
-4.3 percent change
Standard Deviation 20.3
|
|
Percent Change From Baseline in CrCl
Week 92, Measured/Urinalysis (n=37,37)
|
3.1 percent change
Standard Deviation 45.6
|
2.0 percent change
Standard Deviation 39.1
|
Adverse Events
Ibandronate
Serious events: 27 serious events
Other events: 43 other events
Deaths: 0 deaths
Zoledronate
Serious events: 18 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibandronate
n=46 participants at risk
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=43 participants at risk
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Cardiac disorders
Arrhythmia
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Cardiac disorders
Cardiac failure
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Diverticulum
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
Asthenia
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
General physical health deterioration
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
Pyrexia
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Bronchitis
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Bronchopneumonia
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Gastroenteritis
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Herpes zoster
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Implant site infection
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Infection
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Pneumonia
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Septic shock
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Urosepsis
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Investigations
Blood creatinine increased
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Investigations
Creatinine renal clearance decreased
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
9.3%
4/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Renal and urinary disorders
Renal failure
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Renal and urinary disorders
Renal failure acute
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Renal and urinary disorders
Renal failure chronic
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Vascular disorders
Circulatory collapse
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
Other adverse events
| Measure |
Ibandronate
n=46 participants at risk
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
Zoledronate
n=43 participants at risk
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.9%
11/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
25.6%
11/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.7%
10/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
16.3%
7/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
6/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Ear and labyrinth disorders
Vertigo
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
4.7%
2/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.7%
10/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
18.6%
8/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
6/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
20.9%
9/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Constipation
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
9.3%
4/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
Oedema peripheral
|
15.2%
7/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
23.3%
10/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
Fatigue
|
15.2%
7/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
16.3%
7/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
Pyrexia
|
13.0%
6/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
16.3%
7/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
Pain
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
9.3%
4/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
Chills
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
Chest pain
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
General disorders
General physical health deterioration
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Nasopharyngitis
|
41.3%
19/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
23.3%
10/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Bronchitis
|
17.4%
8/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Candidiasis
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
11.6%
5/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Herpes zoster
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
16.3%
7/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Influenza
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
4.7%
2/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Pneumonia
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.3%
13/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
20.9%
9/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.9%
11/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
11.6%
5/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.2%
7/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
11.6%
5/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
9.3%
4/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
4.7%
2/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
1/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
2.3%
1/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
4.7%
2/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Nervous system disorders
Polyneuropathy
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
14.0%
6/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Nervous system disorders
Paraesthesia
|
10.9%
5/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Nervous system disorders
Headache
|
10.9%
5/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
4.7%
2/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Nervous system disorders
Dizziness
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Nervous system disorders
Dysgeusia
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Psychiatric disorders
Sleep disorder
|
4.3%
2/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Psychiatric disorders
Insomnia
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.9%
5/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
9.3%
4/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
7.0%
3/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
3/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
0.00%
0/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
4/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
11.6%
5/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/46 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
9.3%
4/43 • From Baseline to end of study (up to Week 96)
Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER