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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group

Secondary outcome:

Differences between groups in persistence

QoL and patient satisfaction

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Agen 47000, France

Aix Les Bains 73100, France

Albert 80300, France

Amboise 37400, France

Amiens 80000, France

Amiens 80094, France

Andernos Les Bains 33510, France

Andrezieux Boutheon 42160, France

Angers 49100, France

Angouleme 16000, France

Annecy 74000, France

Antibes 06600, France

Antony 92160, France

Arcachon 33120, France

Argeles Sur Mer 66700, France

Arles 13200, France

Armentieres 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

Besancon 25000, France

Beziers 34500, France

Billere 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 Saone 71100, France

Chalons En Champagne 51000, France

Charenton Le Pont 94220, France

Chartres 28000, 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

Davezieux 07430, France

DAX 40100, France

Decines 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

Hyeres 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 69006, France

Lyon 69002, 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 13015, France

Marseille 13012, France

Martigues 13500, France

Meaux 77000, France

Mennecy 91540, France

Merignac 33700, France

Meylan 38240, France

Millau 12100, France

Miribel 01700, France

Montbrisson 42600, France

Montelimar 26200, France

Montgeron 91240, France

Montlucon 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

Nimes 30900, France

Nogent Le Rotrou 28400, France

Noisy Le Sec 93130, France

Oloron 64400, France

Orleans 45000, France

Ormesson Sur Marne 94490, France

Orthez 64300, France

Oyonnax 01100, France

Pantin 93500, France

Paris 75116, 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 75004, France

Perpignan 66000, France

Plan de Cuques 13380, France

Poissy 78302, France

Poitiers 86000, France

Pont A 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 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 Lo 50000, France

Saint Nazaire 44600, France

Saint Pierre de Coutances 50200, France

Saint Quentin 02100, France

Saint-affrique 12400, France

Saint-etienne 42000, France

Saint-malo 35400, France

Saint-mande 94160, France

Sainte Maxime 83120, France

Saintes 17100, France

Sarrebourg 57400, France

Sartrouville 78500, France

Sedan 08200, France

Selestat 67600, France

Senlis 60300, France

Strasbourg 67100, France

Strasbourg 67000, 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 Rhone 07300, France

Tours 37000, France

Valenciennes 59300, France

Vandoeuvre-les-nancy 54500, France

Vence 06140, France

Venissieux 69200, France

Vernet Les Bains 66820, France

Villeneuve-sur-lot 47300, France

Villeurbanne 69100, France

Vincennes 94300, France

Additional Information

Starting date: July 2006
Last updated: August 17, 2015

Page last updated: August 23, 2015

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