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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001121-32 | EudraCT Number |
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Main hypothesis: Patients who continue zoledronic acid after year 2 have longer time until progression in bone disease compared to patients who stop treatment after two years?
Secondary hypothesis: Serum will bone markers increase prior to progression in bone disease in the individual patient?
Secondary hypothesis: Low-dose CT will detect more cases of osteolytic bone disease in Multiple Myeloma compared to conventional radiography
Newly diagnosed myeloma patients will be followed for 4 years. The first two years they will be treated with zoledronic acid monthly. At year 2 they will be randomized to A continue treatment for 2 more years or B stop treatment. The primary outcome of the study will be time to progressive bone disease from year 2 and onward.
Serum bone markers will be measured throughout the study. In patients who experience progressive bone disease, development of bone markers prior to the radiological progression will be investigated to see the if it could have been predicted with the use of serum markers
During the four year period patients will have low-dose CT superior and conventional radiography made at predefined time points. The secondary outcome of the study is to compare the sensitivity of the two modalities
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zoledronic acid | Active Comparator | treatment with zoledronic acid for 4 years |
|
| no treatment | Placebo Comparator | treatment with zoledronic acid withheld after two years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic acid will be given to all participants for two years. Then patients will be randomized to A receive 2 more years of treatment or B stop treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| time to first skeletal related event after randomisations at year two | After two years of zoledronic acid treatment patients will be randomized to A continue treatment B stop treatment. | From year two to year four |
| Measure | Description | Time Frame |
|---|---|---|
| Value of serum bone marker ratio (bone resorption / bone formation markers) as predictor of skeletal related related events analysed by time-dependent multiparameter Cox regression analysis. | Development in bone markers prior to progression in osteolytic lesions will be investigated | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lesions identified with conventional radiography and low-dose CT | Patients will have low-dose CT and conventional x-ray made at predefined time points to compare the sensitivity between the two modalities | 4 years |
| register incidence of osteonecrosis of the jaw |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas LunD, MD Ph.D. | Department of hematology, Odense University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense C | 5000 | Denmark |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D010014 | Osteolysis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| 4 years |
| register creatinine levels in serum | nephrotoxicity | 4 years |
| register ionized calcium in serum | hypocalcemia | 4 years |
| 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 |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |