SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis.
1 other identifier
interventional
596
1 country
190
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2006
Typical duration for phase_4
190 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedAugust 18, 2015
August 1, 2015
2.7 years
October 16, 2007
August 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group
12 months
Secondary Outcomes (2)
Differences between groups in persistence
6 months
QoL and patient satisfaction
6 and 12 months
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- ambulatory, post-menopausal women who would benefit from bisphosphonate treatment;
- \>55 years of age;
- naive to bisphosphonate therapy, or lapsed bisphosphonate users \>=6 months.
You may not qualify if:
- inability to stand or sit in an upright position for at least 60 minutes;
- hypersensitivity to bisphosphonates;
- treatment with other drugs affecting bone metabolism;
- history of major upper gastrointestinal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- GlaxoSmithKlinecollaborator
Study Sites (190)
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Agen, 47000, France
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Aix-les-Bains, 73100, France
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Albert, 80300, France
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Amboise, 37400, France
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Amiens, 80000, France
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Amiens, 80094, France
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Andernos-les-Bains, 33510, France
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Andrézieux-Bouthéon, 42160, France
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Angers, 49100, France
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Angoulême, 16000, France
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Annecy, 74000, France
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Antibes, 06600, France
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Antony, 92160, France
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Arcachon, 33120, France
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Argeles, 66700, France
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Arles, 13200, France
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Armentières, 59280, France
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Auch, 32000, France
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Auray, 56400, France
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Aurillac, 15000, France
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Avignon, 84000, France
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Avranches, 50300, France
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Bayonne, 64100, France
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Beaumont S/oise, 95260, France
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Belfort, 90000, France
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Besançon, 25000, France
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Béziers, 34500, France
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Billère, 64140, France
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Blanquefort, 33290, France
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Bolbec, 76210, France
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Bordeaux, 33100, France
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Bordeaux, 33200, France
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Brest, 29200, France
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Bruz, 35170, France
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Caen, 14000, France
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Cagnes-sur-Mer, 06800, France
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Cannes, 06400, France
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Carpentras, 84200, France
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Cavaillon, 84300, France
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Cenon, 33150, France
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Chalon-sur-Saône, 71100, France
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Charenton-le-Pont, 94220, France
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Chartres, 28000, France
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Châlons-en-Champagne, 51000, France
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Chelles, 77000, France
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Chilly-Mazarin, 91380, France
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Choisy-le-Roi, 94600, France
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Clamart, 92140, France
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Clermont-Ferrand, 63000, France
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Clichy, 92110, France
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Clichy, 92210, France
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Colmar, 68000, France
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Cornebarrieu, 31700, France
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Davézieux, 07430, France
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Dax, 40100, France
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Décines-Charpieu, 69150, France
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Dijon, 21000, France
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Dole, 39100, France
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Fontaine, 38600, France
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Fontenay S/bois, 94120, France
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Gourdon, 46300, France
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Granville, 50400, France
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Grenoble, 38000, France
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Hyères, 83400, France
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Issy-les-Moulineaux, 92130, France
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Istres, 13800, France
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L'isle Sur Sorgue, 84800, France
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L'Union, 31240, France
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La Madeleine, 59110, France
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La Roche-sur-Yon, 85000, France
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La Rochelle, 17000, France
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La Trinité, 06340, France
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Lagny-sur-Marne, 77400, France
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Landivisiau, 29400, France
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Langon, 33210, France
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Laval, 53000, France
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Lavaur, 81500, France
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Le Mans, 72000, France
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Le Perreux-sur-Marne, 94170, France
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Les Mureaux, 78130, France
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Libourne, 33500, France
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Lille, 59000, France
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Lille, 59800, France
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Limoges, 87100, France
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Lisieux, 14100, France
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Longwy, 54400, France
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Loos, 59120, France
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Lorient, 56100, France
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Lyon, 69002, France
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Lyon, 69006, France
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Lyon, 69007, France
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Maisons-Alfort, 94700, France
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Mandelieu-la-Napoule, 06210, France
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Marignane, 13700, France
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Maromme, 76150, France
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Marseille, 13006, France
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Marseille, 13008, France
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Marseille, 13012, France
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Marseille, 13015, France
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Martigues, 13500, France
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Meaux, 77000, France
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Mennecy, 91540, France
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Meylan, 38240, France
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Mérignac, 33700, France
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Millau, 12100, France
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Miribel, 01700, France
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Montbrisson, 42600, France
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Montélimar, 26200, France
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Montgeron, 91240, France
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Montluçon, 03100, France
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Montpellier, 34090, France
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Mulhouse, 68100, France
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Muret, 31600, France
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Nancy, 54000, France
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Nantes, 44000, France
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Narbonne, 11000, France
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Neuilly-sur-Seine, 92200, France
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Nice, 06000, France
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Nîmes, 30900, France
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Nogent-le-Rotrou, 28400, France
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Noisy-le-Sec, 93130, France
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Oloron-Sainte-Marie, 64400, France
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Orléans, 45000, France
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Ormesson-sur-Marne, 94490, France
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Orthez, 64300, France
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Oyonnax, 01100, France
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Pantin, 93500, France
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Paris, 75004, France
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Paris, 75007, France
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Paris, 75008, France
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Paris, 75010, France
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Paris, 75011, France
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Paris, 75014, France
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Paris, 75015, France
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Paris, 75017, France
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Paris, 75020, France
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Paris, 75116, France
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Perpignan, 66000, France
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Plan-de-Cuques, 13380, France
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Poissy, 78302, France
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Poitiers, 86000, France
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Pont-à-Mousson, 54700, France
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Puteaux, 92800, France
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Quimper, 29000, France
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Reims, 51100, France
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Rennes, 35000, France
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Rochefort, 17300, France
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Ronchin, 59790, France
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Roquebrune-Cap-Martin, 06190, France
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Rouen, 76000, France
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Rueil-Malmaison, 92500, France
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Saint-Affrique, 12400, France
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Saint-Brieuc, 22000, France
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Saint-Doulchard, 18230, France
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Saint-Etienne, 42000, France
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Saint-Etienne, 42100, France
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Saint-Flour, 15100, France
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Saint-Jacques-de-la-Lande, 35136, France
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Saint-Lô, 50000, France
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Saint-Mandé, 94160, France
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Saint-Nazaire, 44600, France
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Saint-Pierre-de-Coutances, 50200, France
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Saint-Quentin, 02100, France
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Sainte-Maxime, 83120, France
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Saintes, 17100, France
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Sarrebourg, 57400, France
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Sartrouville, 78500, France
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Sedan, 08200, France
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Senlis, 60300, France
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Sélestat, 67600, France
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St-Malo, 35400, France
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Strasbourg, 67000, France
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Strasbourg, 67100, France
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Tassin-la-Demi-Lune, 69160, France
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Thionville, 57100, France
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Toulon, 83000, France
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Toulouse, 31000, France
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Toulouse, 31077, France
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Toulouse, 31400, France
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Tourcoing, 59200, France
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Tournon-sur-Rhône, 07300, France
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Tours, 37000, France
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Valenciennes, 59300, France
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Vandœuvre-lès-Nancy, 54500, France
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Vence, 06140, France
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Vernet-les-Bains, 66820, France
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Vénissieux, 69200, France
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Villeneuve-sur-Lot, 47300, France
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Villeurbanne, 69100, France
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Vincennes, 94300, France
Related Publications (1)
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.
PMID: 21703900DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
July 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 18, 2015
Record last verified: 2015-08