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The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neridronate | Experimental | Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment |
|
| Placebo | Placebo Comparator | Saline solution for infusion: 4 intravenous administrations in a course of 10 days treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neridronate | Drug | Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| knee pain reduction | to assess the efficacy in terms of proportion of patients with a 50% reduction in pain intensity compared to baseline measured by VAS 100 mm scale recorded at the last visit (day 60) | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bone marrow lesions reduction | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massimo Varenna | Contact | 00390258296897 | varenna@gpini.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Gaetano Pini | Recruiting | Milan | MI | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25998450 | Derived | Varenna M, Zucchi F, Failoni S, Becciolini A, Berruto M. Intravenous neridronate in the treatment of acute painful knee osteoarthritis: a randomized controlled study. Rheumatology (Oxford). 2015 Oct;54(10):1826-32. doi: 10.1093/rheumatology/kev123. Epub 2015 May 20. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C053389 | 6-amino-1-hydroxyhexane-1,1-diphosphonate |
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| D012216 |
| Rheumatic Diseases |