Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003264-38 | EudraCT Number |
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Not provided
Slow recruitment
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
This multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (CrCl) reduction greater than (>) 30 percent (%) or an absolute value of 30 milliliters per minute (mL/min) or lower.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate | Experimental | Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks. |
|
| Zoledronate | Active Comparator | Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate | Drug | Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44 | 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. | Baseline, Week 44 |
| Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92 | 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. | Baseline, Week 92 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Skeletal-Related Events (SREs) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ansbach | 91522 | Germany | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Zoledronate | Drug | Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks. |
|
| From Baseline to end of study (up to Week 96) |
| Time to First SRE | 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. | From Baseline to end of study (up to Week 96) |
| Number of SREs for Each Participant | 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. | From Baseline to end of study (up to Week 96) |
| Percentage of Participants With Osteonecrosis of Jaw | The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported. | From Baseline to end of study (up to Week 96) |
| Number of Events of Osteonecrosis of Jaw for Each Participant | 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. | From Baseline to end of study (up to Week 96) |
| Percentage of Participants With Zoledronate Dose Reduction | The percentage of participants with at least 1 zoledronate dose reduction during the study was reported. | From Baseline to end of study (up to Week 96) |
| Number of Zoledronate Dose Reductions for Each Participant | The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study. | From Baseline to end of study (up to Week 96) |
| Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG) | 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. | Baseline and Weeks 44, 92 |
| Percent Change From Baseline in Alpha (A) 1-Microglobulin | 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. | Baseline and Weeks 44, 92 |
| Percent Change From Baseline in Gamma-Glutamyltransferase (GGT) | 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. | Baseline and Weeks 44, 92 |
| Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline | 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. | Baseline and Weeks 44, 92 |
| Percent Change From Baseline in CrCl | 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. | Baseline and Weeks 44, 92 |
| Aschaffenburg |
| 63739 |
| Germany |
| Augsburg | 86150 | Germany |
| Berlin | 10437 | Germany |
| Berlin | 10707 | Germany |
| Berlin | 12627 | Germany |
| Bremen | 28239 | Germany |
| Cologne | 50677 | Germany |
| Cologne | 50924 | Germany |
| Duisburg | 47051 | Germany |
| Duisburg | 47166 | Germany |
| Erlangen | 91054 | Germany |
| Essen | 45136 | Germany |
| Esslingen am Neckar | 73730 | Germany |
| Frankfurt am Main | 60389 | Germany |
| Frankfurt am Main | 65929 | Germany |
| Göttingen | 37075 | Germany |
| Greifswald | 17475 | Germany |
| Güstrow | 18273 | Germany |
| Gütersloh | 33332 | Germany |
| Halle | 06110 | Germany |
| Hamburg | 22081 | Germany |
| Hamburg | 22457 | Germany |
| Hamm | 59063 | Germany |
| Hanover | 30171 | Germany |
| Hanover | 30625 | Germany |
| Herne | 44625 | Germany |
| Hof | 95028 | Germany |
| Jena | 07743 | Germany |
| Karlsruhe | 76137 | Germany |
| Kassel | 34117 | Germany |
| Kassel | 34125 | Germany |
| Koblenz | 56068 | Germany |
| Krefeld | 47798 | Germany |
| Leer | 26789 | Germany |
| Leipzig | 04289 | Germany |
| Ludwigshafen | 67063 | Germany |
| Lübeck | 23562 | Germany |
| Magedburg | 39104 | Germany |
| Minden | 32427 | Germany |
| Moers | 47441 | Germany |
| Mülheim | 45468 | Germany |
| München | 80336 | Germany |
| Münster | 48149 | Germany |
| Neumünster | 24534 | Germany |
| Offenbach | 63069 | Germany |
| Offenburg | 77652 | Germany |
| Oldenburg | 26121 | Germany |
| Oldenburg | 26133 | Germany |
| Stuttgart | 70174 | Germany |
| Stuttgart | 70199 | Germany |
| Tübingen | 72076 | Germany |
| Weiden | 92637 | Germany |
| Wiesbaden | 65191 | Germany |
| Würzburg | 97080 | Germany |
| Zwickau | 08058 | Germany |
| FG001 | 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. |
| Completed at Week 44 |
|
| Completed at Week 96 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Population: All participants who were randomized and received at least one dose of study medication and for whom at least one measurement of creatinine clearance (CrCl) was obtained.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibandronate | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44 | 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. | Intent-to-Treat (ITT) Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 44 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92 | 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. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 92 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Skeletal-Related Events (SREs) | 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. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline to end of study (up to Week 96) |
| ||||||||||||||||||||||||||||||
| Secondary | Time to First SRE | 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. | ITT Population. | Posted | Median | Full Range | days | From Baseline to end of study (up to Week 96) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of SREs for Each Participant | 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. | ITT Population. | Posted | Mean | Standard Deviation | SREs | From Baseline to end of study (up to Week 96) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Osteonecrosis of Jaw | The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline to end of study (up to Week 96) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Events of Osteonecrosis of Jaw for Each Participant | 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. | ITT Population. | Posted | Mean | Standard Deviation | events of osteonecrosis of jaw | From Baseline to end of study (up to Week 96) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Zoledronate Dose Reduction | The percentage of participants with at least 1 zoledronate dose reduction during the study was reported. | ITT Population; only the Zoledronate arm was included. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline to end of study (up to Week 96) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Zoledronate Dose Reductions for Each Participant | The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study. | ITT Population; only the Zoledronate arm was included. | Posted | Mean | Standard Deviation | dose reductions | From Baseline to end of study (up to Week 96) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG) | 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. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint. | Posted | Median | Full Range | percent change | Baseline and Weeks 44, 92 |
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Alpha (A) 1-Microglobulin | 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. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint. | Posted | Median | Full Range | percent change | Baseline and Weeks 44, 92 |
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Gamma-Glutamyltransferase (GGT) | 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. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint. | Posted | Median | Full Range | percent change | Baseline and Weeks 44, 92 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline | 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. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 44, 92 |
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in CrCl | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline and Weeks 44, 92 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibandronate | 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. | 27 | 46 | 43 | 46 | ||
| EG001 | 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. | 18 | 43 | 34 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
The Study was terminated as a result of slow recruitment. At the time of the decision to halt recruitment, the treatment duration was shortened to 40 weeks (instead of 92 weeks) for those participants who had not yet reached Week 48.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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