SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.

NCT ID: NCT00545480

Last Updated: 2015-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post Menopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

150mg po monthly for 12 months (with feedback)

2

Group Type ACTIVE_COMPARATOR

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

150mg po monthly for 12 months (without feedback)

Interventions

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ibandronate [Bonviva/Boniva]

150mg po monthly for 12 months (with feedback)

Intervention Type DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 12 months (without feedback)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ambulatory, post-menopausal women who would benefit from bisphosphonate treatment;
* \>55 years of age;
* naive to bisphosphonate therapy, or lapsed bisphosphonate users \>=6 months.

Exclusion Criteria

* 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.
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Agen, , France

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Aix-les-Bains, , France

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Albert, , France

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Amboise, , France

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Amiens, , France

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Amiens, , France

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Andernos-les-Bains, , France

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Andrézieux-Bouthéon, , France

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Angers, , France

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Angoulême, , France

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Annecy, , France

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Antibes, , France

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Antony, , France

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Arcachon, , France

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Argeles, , France

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Arles, , France

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Armentières, , France

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Auch, , France

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Auray, , France

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Aurillac, , France

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Avignon, , France

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Avranches, , France

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Bayonne, , France

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Beaumont S/oise, , France

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Belfort, , France

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Besançon, , France

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Béziers, , France

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Billère, , France

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Blanquefort, , France

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Bolbec, , France

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Bordeaux, , France

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Bordeaux, , France

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Brest, , France

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Bruz, , France

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Caen, , France

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Cagnes-sur-Mer, , France

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Cannes, , France

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Carpentras, , France

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Cavaillon, , France

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Cenon, , France

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Chalon-sur-Saône, , France

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Charenton-le-Pont, , France

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Chartres, , France

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Châlons-en-Champagne, , France

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Chelles, , France

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Chilly-Mazarin, , France

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Choisy-le-Roi, , France

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Clamart, , France

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Clermont-Ferrand, , France

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Clichy, , France

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Clichy, , France

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Colmar, , France

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Cornebarrieu, , France

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Davézieux, , France

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Dax, , France

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Décines-Charpieu, , France

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Dijon, , France

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Dole, , France

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Fontaine, , France

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Fontenay S/bois, , France

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Gourdon, , France

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Granville, , France

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Grenoble, , France

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Hyères, , France

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Issy-les-Moulineaux, , France

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Istres, , France

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L'isle Sur Sorgue, , France

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L'Union, , France

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La Madeleine, , France

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La Roche-sur-Yon, , France

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La Rochelle, , France

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La Trinité, , France

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Lagny-sur-Marne, , France

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Landivisiau, , France

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Langon, , France

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Laval, , France

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Lavaur, , France

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Le Mans, , France

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Le Perreux-sur-Marne, , France

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Les Mureaux, , France

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Libourne, , France

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Lille, , France

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Lille, , France

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Limoges, , France

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Lisieux, , France

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Longwy, , France

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Loos, , France

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Lorient, , France

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Lyon, , France

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Lyon, , France

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Lyon, , France

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Maisons-Alfort, , France

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Mandelieu-la-Napoule, , France

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Marignane, , France

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Maromme, , France

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Marseille, , France

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Marseille, , France

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Marseille, , France

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Marseille, , France

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Martigues, , France

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Meaux, , France

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Mennecy, , France

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Meylan, , France

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Mérignac, , France

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Millau, , France

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Miribel, , France

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Montbrisson, , France

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Montélimar, , France

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Montgeron, , France

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Montluçon, , France

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Montpellier, , France

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Mulhouse, , France

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Muret, , France

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Nancy, , France

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Nantes, , France

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Narbonne, , France

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Neuilly-sur-Seine, , France

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Nice, , France

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Nîmes, , France

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Nogent-le-Rotrou, , France

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Noisy-le-Sec, , France

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Oloron-Sainte-Marie, , France

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Orléans, , France

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Ormesson-sur-Marne, , France

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Orthez, , France

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Oyonnax, , France

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Pantin, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Perpignan, , France

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Plan-de-Cuques, , France

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Poissy, , France

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Poitiers, , France

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Pont-à-Mousson, , France

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Puteaux, , France

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Quimper, , France

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Reims, , France

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Rennes, , France

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Rochefort, , France

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Ronchin, , France

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Roquebrune-Cap-Martin, , France

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Rouen, , France

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Rueil-Malmaison, , France

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Saint-Affrique, , France

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Saint-Brieuc, , France

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Saint-Doulchard, , France

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Saint-Etienne, , France

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Saint-Etienne, , France

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Saint-Flour, , France

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Saint-Jacques-de-la-Lande, , France

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Saint-Lô, , France

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Saint-Mandé, , France

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Saint-Nazaire, , France

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Saint-Pierre-de-Coutances, , France

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Saint-Quentin, , France

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Sainte-Maxime, , France

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Saintes, , France

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Sarrebourg, , France

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Sartrouville, , France

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Sedan, , France

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Senlis, , France

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Sélestat, , France

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St-Malo, , France

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Strasbourg, , France

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Strasbourg, , France

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Tassin-la-Demi-Lune, , France

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Thionville, , France

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Toulon, , France

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Toulouse, , France

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Toulouse, , France

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Toulouse, , France

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Tourcoing, , France

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Tournon-sur-Rhône, , France

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Tours, , France

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Valenciennes, , France

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Vandœuvre-lès-Nancy, , France

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Vence, , France

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Vernet-les-Bains, , France

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Vénissieux, , France

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Villeneuve-sur-Lot, , France

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Villeurbanne, , France

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Vincennes, , France

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Countries

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France

References

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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.

Reference Type DERIVED
PMID: 21703900 (View on PubMed)

Other Identifiers

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ML19358

Identifier Type: -

Identifier Source: org_study_id

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