Trial information
SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
Status: No longer recruiting
Protocol number: ML19358
Sponsor: Hoffmann-La Roche; Glaxo Smithkline
Company division: Pharmaceutical
Official Scientific 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.
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. Target sample size is 800.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate [Bonviva/Boniva]
Primary outcome: 1. Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group Time frame: 12 months
Key secondary outcomes: 1. Differences between groups in persistence Time frame: 6 months
2. QoL and patient satisfaction Time frame: 6 and 12 months
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.
Gender: Females
Age limits: Min: 55 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2006
Trial registration date: 06/16/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
France
- Agen
- Aix Les Bains
- Amiens
- Andernos Les Bains
- Andrezieux Boutheon
- Angers
- Annecy
- Antibes
- Arcachon
- Argeles Sur Mer
- Arles
- Armentieres
- Auch
- Auray
- Aurillac
- Avignon
- Bayonne
- Belfort
- Besancon
- Beziers
- Billere
- Blanquefort
- Bordeaux
- Bruz
- Caen
- Cagnes-Sur-Mer
- Cannes
- Carpentras
- Cavaillon
- Cenon
- Chalons En Champagne
- Chartres
- Chelles
- Clichy
- Colmar
- Cornebarrieu
- Decines
- Dijon
- Dole
- Gourdon
- Granville
- Grenoble
- Hyeres
- La Madeleine
- La Roche Sur Yon
- La Rochelle
- Landivisiau
- Langon
- Laval
- Le Mans
- Les Pavillons Sous Bois
- Lille
- Limoges
- L'Isle Sur Sorgue
- Longwy
- Loos
- L'Union
- Lyon
- Maisons-Alfort
- Marignane
- Marseille
- Martigues
- Mennecy
- Meylan
- Millau
- Miribel
- Montelimar
- Montgeron
- Montpellier
- Mulhouse
- Muret
- Nancy
- Nantes
- Neuilly-Sur-Seine
- Nice
- Noisy Le Sec
- Oloron
- Orleans
- Ormesson Sur Marne
- Orthez
- Pantin
- Paris
- Perpignan
- Plan De Cuques
- Poitiers
- Reims
- Rochefort
- Ronchin
- Roquebrune Cap Martin
- Rueil-Malmaison
- Saint Brieuc
- Saint Doulchard
- Saint Etienne
- Saint Flour
- Saint Jacques De La Lande
- Saint Lo
- Saint Quentin
- Saint-Affrique
- Sainte Maxime
- Saint-Etienne
- Saint-Malo
- Sarrebourg
- Sartrouville
- Sedan
- Selestat
- Strasbourg
- Thionville
- Toulon
- Toulouse
- Tourcoing
- Tournon Sur Rhone
- Tours
- Valenciennes
- Vandoeuvre-Les-Nancy
- Vence
- Vernet Les Bains
- Villeneuve-Sur-Lot
- Villeurbanne
- Vincennes
