SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 persistenceQoL 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
VILLEURBANNE 69100, France
SAINT BRIEUC 22000, France
LAVAL 53000, France
STRASBOURG 67000, France
MARTIGUES 13500, France
ARLES 13200, France
MONTPELLIER 34090, France
CENON 33150, France
BESANCON 25000, France
SAINT JACQUES DE LA LANDE 35136, France
CHELLES 77000, France
HYERES 83400, France
TOULON 83000, France
SAINTE MAXIME 83120, France
MARSEILLE 13008, France
PLAN DE CUQUES 13380, France
LIMOGES 87100, France
SAINT-AFFRIQUE 12400, France
SAINT-ETIENNE 42000, France
PARIS 75017, France
SARREBOURG 57400, France
DOLE 39100, France
MONTGERON 91240, France
GRENOBLE 38000, France
NICE 06000, France
OLORON 64400, France
BAYONNE 64100, France
SAINT LO 50000, France
RONCHIN 59790, France
BEZIERS 34500, France
MURET 31600, France
TOULOUSE 31400, France
AURILLAC 15000, France
DECINES 69150, France
VERNET LES BAINS 66820, France
SELESTAT 67600, France
BELFORT 90000, France
MARSEILLE 13006, France
L'UNION 31240, France
LANGON 33210, France
BORDEAUX 33100, France
CARPENTRAS 84200, France
ARMENTIERES 59280, France
PARIS 75015, France
DIJON 21000, France
LA ROCHE SUR YON 85000, France
ANDERNOS LES BAINS 33510, France
LOOS 59120, France
MILLAU 12100, France
AIX LES BAINS 73100, France
BILLERE 64140, France
SAINT FLOUR 15100, France
THIONVILLE 57100, France
SAINT DOULCHARD 18230, France
LANDIVISIAU 29400, France
LE MANS 72000, France
ANNECY 74000, France
AUCH 32000, France
CHARTRES 28000, France
TOURS 37000, France
AVIGNON 84000, France
ORMESSON SUR MARNE 94490, France
ROCHEFORT 17300, France
NANCY 54000, France
RUEIL-MALMAISON 92500, France
BRUZ 35170, France
LILLE 59000, France
CHALONS EN CHAMPAGNE 51000, France
GRANVILLE 50400, France
PARIS 75020, France
LA ROCHELLE 17000, France
PARIS 75008, France
ANGERS 49100, France
VANDOEUVRE-LES-NANCY 54500, France
AMIENS 80000, France
CAEN 14000, France
LONGWY 54400, France
ROQUEBRUNE CAP MARTIN 06190, France
CAVAILLON 84300, France
ANTIBES 06600, France
MONTELIMAR 26200, France
AURAY 56400, France
MENNECY 91540, France
SARTROUVILLE 78500, France
SAINT ETIENNE 42100, France
MIRIBEL 01700, France
LES PAVILLONS SOUS BOIS 93320, France
CLICHY 92110, France
NANTES 44000, France
GOURDON 46300, France
LILLE 59800, France
MAISONS-ALFORT 94700, France
TOULOUSE 31000, France
LA MADELEINE 59110, France
CAGNES-SUR-MER 06800, France
NEUILLY-SUR-SEINE 92200, France
PARIS 75014, France
TOURNON SUR RHONE 07300, France
MULHOUSE 68100, France
POITIERS 86000, France
SEDAN 08200, France
LYON 69007, France
LYON 69002, France
ORLEANS 45000, France
CANNES 06400, France
AGEN 47000, France
CLICHY 92210, France
REIMS 51100, France
NOISY LE SEC 93130, France
VINCENNES 94300, France
ARCACHON 33120, France
L'ISLE SUR SORGUE 84800, France
ORTHEZ 64300, France
VILLENEUVE-SUR-LOT 47300, France
PARIS 75116, France
BLANQUEFORT 33290, France
MEYLAN 38240, France
PERPIGNAN 66000, France
SAINT-MALO 35400, France
PANTIN 93500, France
COLMAR 68000, France
VENCE 06140, France
CORNEBARRIEU 31700, France
ANDREZIEUX BOUTHEON 42160, France
VALENCIENNES 59300, France
TOURCOING 59200, France
SAINT ETIENNE 42000, France
MARIGNANE 13700, France
ARGELES SUR MER 66700, France
SAINT QUENTIN 02100, France
TOULOUSE 31077, France
Additional Information
Starting date: July 2006
Ending date: September 2008
Last updated: June 17, 2008
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