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This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo i.v. single dose |
| |
| ibandronate [Bonviva/Boniva] |
| Measure | Description | Time Frame |
|---|---|---|
| Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7). | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with >=50% diminution of pain between day 0 and 7 | Day 7 | |
| Pain control | Day 7 and 1 month | |
| Analgesic medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aix-en-Provence | 13616 | France | ||||
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| Drug |
3mg i.v. single dose |
|
| 1 month |
| Hospitalization | 1 month |
| AEs and laboratory parameters | Throughout study |
| Amiens |
| 80054 |
| France |
| Angers | 49033 | France |
| Bonneville | 74136 | France |
| Bordeaux | 33076 | France |
| Caen | 14033 | France |
| Cannes | 06401 | France |
| Clermont-Ferrand | 63003 | France |
| Échirolles | 38434 | France |
| Lille | 59037 | France |
| Lomme | 59462 | France |
| Marseille | 13285 | France |
| Marseille | 13385 | France |
| Montpellier | 34295 | France |
| Mulhouse | 68070 | France |
| Nantes | 44035 | France |
| Nice | 06202 | France |
| Orléans | 45000 | France |
| Paris | 75181 | France |
| Paris | 75475 | France |
| Paris | 75571 | France |
| Paris | 75651 | France |
| Paris | 75674 | France |
| Rennes | 35203 | France |
| Rouen | 76031 | France |
| Saint-Priest-en-Jarez | 42277 | France |
| Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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