Clinical trial NCT00545480: SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2007-10-17
Enrollment: 596
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group
timeFrame: 12 months
Secondary outcomes:
measure: Differences between groups in persistence
timeFrame: 6 months
measure: QoL and patient satisfaction
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Agen
country: France
city: Aix Les Bains
country: France
city: Albert
country: France
city: Amboise
country: France
city: Amiens
country: France
city: Amiens
country: France
city: Andernos Les Bains
country: France
city: Andrezieux Boutheon
country: France
city: Angers
country: France
city: Angouleme
country: France
city: Annecy
country: France
city: Antibes
country: France
city: Antony
country: France
city: Arcachon
country: France
city: Argeles Sur Mer
country: France
city: Arles
country: France
city: Armentieres
country: France
city: Auch
country: France
city: Auray
country: France
city: Aurillac
country: France
city: Avignon
country: France
city: Avranches
country: France
city: Bayonne
country: France
city: Beaumont S/oise
country: France
city: Belfort
country: France
city: Besancon
country: France
city: Beziers
country: France
city: Billere
country: France
city: Blanquefort
country: France
city: Bolbec
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Bruz
country: France
city: Caen
country: France
city: Cagnes-sur-mer
country: France
city: Cannes
country: France
city: Carpentras
country: France
city: Cavaillon
country: France
city: Cenon
country: France
city: Chalon Sur Saone
country: France
city: Chalons En Champagne
country: France
city: Charenton Le Pont
country: France
city: Chartres
country: France
city: Chelles
country: France
city: Chilly-mazarin
country: France
city: Choisy Le Roi
country: France
city: Clamart
country: France
city: Clermont-ferrand
country: France
city: Clichy
country: France
city: Clichy
country: France
city: Colmar
country: France
city: Cornebarrieu
country: France
city: Davezieux
country: France
city: DAX
country: France
city: Decines
country: France
city: Dijon
country: France
city: Dole
country: France
city: Fontaine
country: France
city: Fontenay S/bois
country: France
city: Gourdon
country: France
city: Granville
country: France
city: Grenoble
country: France
city: Hyeres
country: France
city: Issy Les Moulineaux
country: France
city: Istres
country: France
city: L'isle Sur Sorgue
country: France
city: L'union
country: France
city: La Madeleine
country: France
city: La Roche Sur Yon
country: France
city: La Rochelle
country: France
city: La Trinité
country: France
city: Lagny-sur-marne
country: France
city: Landivisiau
country: France
city: Langon
country: France
city: Laval
country: France
city: Lavaur
country: France
city: Le Mans
country: France
city: Le Perreux Sur Marne
country: France
city: Les Mureaux
country: France
city: Libourne
country: France
city: Lille
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lisieux
country: France
city: Longwy
country: France
city: Loos
country: France
city: Lorient
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Maisons-alfort
country: France
city: Mandelieu La Napoule
country: France
city: Marignane
country: France
city: Maromme
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Martigues
country: France
city: Meaux
country: France
city: Mennecy
country: France
city: Merignac
country: France
city: Meylan
country: France
city: Millau
country: France
city: Miribel
country: France
city: Montbrisson
country: France
city: Montelimar
country: France
city: Montgeron
country: France
city: Montlucon
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Muret
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Narbonne
country: France
city: Neuilly-sur-seine
country: France
city: Nice
country: France
city: Nimes
country: France
city: Nogent Le Rotrou
country: France
city: Noisy Le Sec
country: France
city: Oloron
country: France
city: Orleans
country: France
city: Ormesson Sur Marne
country: France
city: Orthez
country: France
city: Oyonnax
country: France
city: Pantin
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Plan de Cuques
country: France
city: Poissy
country: France
city: Poitiers
country: France
city: Pont A Mousson
country: France
city: Puteaux
country: France
city: Quimper
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rochefort
country: France
city: Ronchin
country: France
city: Roquebrune Cap Martin
country: France
city: Rouen
country: France
city: Rueil-malmaison
country: France
city: Saint Brieuc
country: France
city: Saint Doulchard
country: France
city: Saint Etienne
country: France
city: Saint Etienne
country: France
city: Saint Flour
country: France
city: Saint Jacques de La Lande
country: France
city: Saint Lo
country: France
city: Saint Nazaire
country: France
city: Saint Pierre de Coutances
country: France
city: Saint Quentin
country: France
city: Saint-affrique
country: France
city: Saint-etienne
country: France
city: Saint-malo
country: France
city: Saint-mande
country: France
city: Sainte Maxime
country: France
city: Saintes
country: France
city: Sarrebourg
country: France
city: Sartrouville
country: France
city: Sedan
country: France
city: Selestat
country: France
city: Senlis
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Tassin La Demi-lune
country: France
city: Thionville
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Tournon Sur Rhone
country: France
city: Tours
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vence
country: France
city: Venissieux
country: France
city: Vernet Les Bains
country: France
city: Villeneuve-sur-lot
country: France
city: Villeurbanne
country: France
city: Vincennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.