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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate [Bonviva/Boniva] | Drug | 150mg po monthly for 12 months (with feedback) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between groups in persistence | 6 months | |
| QoL and patient satisfaction | 6 and 12 months |
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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 |
|---|---|---|---|---|---|---|
| Agen | 47000 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21703900 | Derived | Roux C, Giraudeau B, Rouanet S, Dubourg G, Perrodeau E, Ravaud P. Monitoring of bone turnover markers does not improve persistence with ibandronate treatment. Joint Bone Spine. 2012 Jul;79(4):389-92. doi: 10.1016/j.jbspin.2011.05.001. Epub 2011 Jun 23. |
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| ibandronate [Bonviva/Boniva] |
| Drug |
150mg po monthly for 12 months (without feedback) |
|
| Aix-les-Bains |
| 73100 |
| France |
| Albert | 80300 | France |
| Amboise | 37400 | France |
| Amiens | 80000 | France |
| Amiens | 80094 | France |
| Andernos-les-Bains | 33510 | France |
| Andrézieux-Bouthéon | 42160 | France |
| Angers | 49100 | France |
| Angoulême | 16000 | France |
| Annecy | 74000 | France |
| Antibes | 06600 | France |
| Antony | 92160 | France |
| Arcachon | 33120 | France |
| Argeles | 66700 | France |
| Arles | 13200 | France |
| Armentières | 59280 | France |
| Auch | 32000 | France |
| Auray | 56400 | France |
| Aurillac | 15000 | France |
| Avignon | 84000 | France |
| Avranches | 50300 | France |
| Bayonne | 64100 | France |
| Beaumont S/oise | 95260 | France |
| Belfort | 90000 | France |
| Besançon | 25000 | France |
| Béziers | 34500 | France |
| Billère | 64140 | France |
| Blanquefort | 33290 | France |
| Bolbec | 76210 | France |
| Bordeaux | 33100 | France |
| Bordeaux | 33200 | France |
| Brest | 29200 | France |
| Bruz | 35170 | France |
| Caen | 14000 | France |
| Cagnes-sur-Mer | 06800 | France |
| Cannes | 06400 | France |
| Carpentras | 84200 | France |
| Cavaillon | 84300 | France |
| Cenon | 33150 | France |
| Chalon-sur-Saône | 71100 | France |
| Charenton-le-Pont | 94220 | France |
| Chartres | 28000 | France |
| Châlons-en-Champagne | 51000 | France |
| Chelles | 77000 | France |
| Chilly-Mazarin | 91380 | France |
| Choisy-le-Roi | 94600 | France |
| Clamart | 92140 | France |
| Clermont-Ferrand | 63000 | France |
| Clichy | 92110 | France |
| Clichy | 92210 | France |
| Colmar | 68000 | France |
| Cornebarrieu | 31700 | France |
| Davézieux | 07430 | France |
| Dax | 40100 | France |
| Décines-Charpieu | 69150 | France |
| Dijon | 21000 | France |
| Dole | 39100 | France |
| Fontaine | 38600 | France |
| Fontenay S/bois | 94120 | France |
| Gourdon | 46300 | France |
| Granville | 50400 | France |
| Grenoble | 38000 | France |
| Hyères | 83400 | France |
| Issy-les-Moulineaux | 92130 | France |
| Istres | 13800 | France |
| L'isle Sur Sorgue | 84800 | France |
| L'Union | 31240 | France |
| La Madeleine | 59110 | France |
| La Roche-sur-Yon | 85000 | France |
| La Rochelle | 17000 | France |
| La Trinité | 06340 | France |
| Lagny-sur-Marne | 77400 | France |
| Landivisiau | 29400 | France |
| Langon | 33210 | France |
| Laval | 53000 | France |
| Lavaur | 81500 | France |
| Le Mans | 72000 | France |
| Le Perreux-sur-Marne | 94170 | France |
| Les Mureaux | 78130 | France |
| Libourne | 33500 | France |
| Lille | 59000 | France |
| Lille | 59800 | France |
| Limoges | 87100 | France |
| Lisieux | 14100 | France |
| Longwy | 54400 | France |
| Loos | 59120 | France |
| Lorient | 56100 | France |
| Lyon | 69002 | France |
| Lyon | 69006 | France |
| Lyon | 69007 | France |
| Maisons-Alfort | 94700 | France |
| Mandelieu-la-Napoule | 06210 | France |
| Marignane | 13700 | France |
| Maromme | 76150 | France |
| Marseille | 13006 | France |
| Marseille | 13008 | France |
| Marseille | 13012 | France |
| Marseille | 13015 | France |
| Martigues | 13500 | France |
| Meaux | 77000 | France |
| Mennecy | 91540 | France |
| Meylan | 38240 | France |
| Mérignac | 33700 | France |
| Millau | 12100 | France |
| Miribel | 01700 | France |
| Montbrisson | 42600 | France |
| Montélimar | 26200 | France |
| Montgeron | 91240 | France |
| Montluçon | 03100 | France |
| Montpellier | 34090 | France |
| Mulhouse | 68100 | France |
| Muret | 31600 | France |
| Nancy | 54000 | France |
| Nantes | 44000 | France |
| Narbonne | 11000 | France |
| Neuilly-sur-Seine | 92200 | France |
| Nice | 06000 | France |
| Nîmes | 30900 | France |
| Nogent-le-Rotrou | 28400 | France |
| Noisy-le-Sec | 93130 | France |
| Oloron-Sainte-Marie | 64400 | France |
| Orléans | 45000 | France |
| Ormesson-sur-Marne | 94490 | France |
| Orthez | 64300 | France |
| Oyonnax | 01100 | France |
| Pantin | 93500 | France |
| Paris | 75004 | France |
| Paris | 75007 | France |
| Paris | 75008 | France |
| Paris | 75010 | France |
| Paris | 75011 | France |
| Paris | 75014 | France |
| Paris | 75015 | France |
| Paris | 75017 | France |
| Paris | 75020 | France |
| Paris | 75116 | France |
| Perpignan | 66000 | France |
| Plan-de-Cuques | 13380 | France |
| Poissy | 78302 | France |
| Poitiers | 86000 | France |
| Pont-à-Mousson | 54700 | France |
| Puteaux | 92800 | France |
| Quimper | 29000 | France |
| Reims | 51100 | France |
| Rennes | 35000 | France |
| Rochefort | 17300 | France |
| Ronchin | 59790 | France |
| Roquebrune-Cap-Martin | 06190 | France |
| Rouen | 76000 | France |
| Rueil-Malmaison | 92500 | France |
| Saint-Affrique | 12400 | France |
| Saint-Brieuc | 22000 | France |
| Saint-Doulchard | 18230 | France |
| Saint-Etienne | 42000 | France |
| Saint-Etienne | 42100 | France |
| Saint-Flour | 15100 | France |
| Saint-Jacques-de-la-Lande | 35136 | France |
| Saint-Lô | 50000 | France |
| Saint-Mandé | 94160 | France |
| Saint-Nazaire | 44600 | France |
| Saint-Pierre-de-Coutances | 50200 | France |
| Saint-Quentin | 02100 | France |
| Sainte-Maxime | 83120 | France |
| Saintes | 17100 | France |
| Sarrebourg | 57400 | France |
| Sartrouville | 78500 | France |
| Sedan | 08200 | France |
| Senlis | 60300 | France |
| Sélestat | 67600 | France |
| St-Malo | 35400 | France |
| Strasbourg | 67000 | France |
| Strasbourg | 67100 | France |
| Tassin-la-Demi-Lune | 69160 | France |
| Thionville | 57100 | France |
| Toulon | 83000 | France |
| Toulouse | 31000 | France |
| Toulouse | 31077 | France |
| Toulouse | 31400 | France |
| Tourcoing | 59200 | France |
| Tournon-sur-Rhône | 07300 | France |
| Tours | 37000 | France |
| Valenciennes | 59300 | France |
| Vandœuvre-lès-Nancy | 54500 | France |
| Vence | 06140 | France |
| Vernet-les-Bains | 66820 | France |
| Vénissieux | 69200 | France |
| Villeneuve-sur-Lot | 47300 | France |
| Villeurbanne | 69100 | France |
| Vincennes | 94300 | France |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| 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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