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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545480
First received: October 16, 2007
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This 2 arm study will assess the impact of bone marker feedback, using blood sam pling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also asses s safety, quality of life and patient satisfaction. All patients will receive Bo nviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-f eedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Condition Intervention Phase
Post-Menopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences between groups in persistence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • QoL and patient satisfaction [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 596
Study Start Date: July 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (with feedback)
Active Comparator: 2 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (without feedback)

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545480

  Hide Study Locations
Locations
France
Agen, France, 47000
Aix Les Bains, France, 73100
Albert, France, 80300
Amboise, France, 37400
Amiens, France, 80000
Amiens, France, 80094
Andernos Les Bains, France, 33510
Andrezieux Boutheon, France, 42160
Angers, France, 49100
Angouleme, France, 16000
Annecy, France, 74000
Antibes, France, 06600
Antony, France, 92160
Arcachon, France, 33120
Argeles Sur Mer, France, 66700
Arles, France, 13200
Armentieres, France, 59280
Auch, France, 32000
Auray, France, 56400
Aurillac, France, 15000
Avignon, France, 84000
Avranches, France, 50300
Bayonne, France, 64100
Beaumont S/oise, France, 95260
Belfort, France, 90000
Besancon, France, 25000
Beziers, France, 34500
Billere, France, 64140
Blanquefort, France, 33290
Bolbec, France, 76210
Bordeaux, France, 33100
Bordeaux, France, 33200
Brest, France, 29200
Bruz, France, 35170
Caen, France, 14000
Cagnes-sur-mer, France, 06800
Cannes, France, 06400
Carpentras, France, 84200
Cavaillon, France, 84300
Cenon, France, 33150
Chalon Sur Saone, France, 71100
Chalons En Champagne, France, 51000
Charenton Le Pont, France, 94220
Chartres, France, 28000
Chelles, France, 77000
Chilly-mazarin, France, 91380
Choisy Le Roi, France, 94600
Clamart, France, 92140
Clermont-ferrand, France, 63000
Clichy, France, 92110
Clichy, France, 92210
Colmar, France, 68000
Cornebarrieu, France, 31700
Davezieux, France, 07430
DAX, France, 40100
Decines, France, 69150
Dijon, France, 21000
Dole, France, 39100
Fontaine, France, 38600
Fontenay S/bois, France, 94120
Gourdon, France, 46300
Granville, France, 50400
Grenoble, France, 38000
Hyeres, France, 83400
Issy Les Moulineaux, France, 92130
Istres, France, 13800
L'isle Sur Sorgue, France, 84800
L'union, France, 31240
La Madeleine, France, 59110
La Roche Sur Yon, France, 85000
La Rochelle, France, 17000
La Trinité, France, 06340
Lagny-sur-marne, France, 77400
Landivisiau, France, 29400
Langon, France, 33210
Laval, France, 53000
Lavaur, France, 81500
Le Mans, France, 72000
Le Perreux Sur Marne, France, 94170
Les Mureaux, France, 78130
Libourne, France, 33500
Lille, France, 59000
Lille, France, 59800
Limoges, France, 87100
Lisieux, France, 14100
Longwy, France, 54400
Loos, France, 59120
Lorient, France, 56100
Lyon, France, 69002
Lyon, France, 69007
Lyon, France, 69006
Maisons-alfort, France, 94700
Mandelieu La Napoule, France, 06210
Marignane, France, 13700
Maromme, France, 76150
Marseille, France, 13006
Marseille, France, 13008
Marseille, France, 13015
Marseille, France, 13012
Martigues, France, 13500
Meaux, France, 77000
Mennecy, France, 91540
Merignac, France, 33700
Meylan, France, 38240
Millau, France, 12100
Miribel, France, 01700
Montbrisson, France, 42600
Montelimar, France, 26200
Montgeron, France, 91240
Montlucon, France, 03100
Montpellier, France, 34090
Mulhouse, France, 68100
Muret, France, 31600
Nancy, France, 54000
Nantes, France, 44000
Narbonne, France, 11000
Neuilly-sur-seine, France, 92200
Nice, France, 06000
Nimes, France, 30900
Nogent Le Rotrou, France, 28400
Noisy Le Sec, France, 93130
Oloron, France, 64400
Orleans, France, 45000
Ormesson Sur Marne, France, 94490
Orthez, France, 64300
Oyonnax, France, 01100
Pantin, France, 93500
Paris, France, 75011
Paris, France, 75008
Paris, France, 75015
Paris, France, 75010
Paris, France, 75017
Paris, France, 75014
Paris, France, 75004
Paris, France, 75116
Paris, France, 75007
Paris, France, 75020
Perpignan, France, 66000
Plan de Cuques, France, 13380
Poissy, France, 78302
Poitiers, France, 86000
Pont A Mousson, France, 54700
Puteaux, France, 92800
Quimper, France, 29000
Reims, France, 51100
Rennes, France, 35000
Rochefort, France, 17300
Ronchin, France, 59790
Roquebrune Cap Martin, France, 06190
Rouen, France, 76000
Rueil-malmaison, France, 92500
Saint Brieuc, France, 22000
Saint Doulchard, France, 18230
Saint Etienne, France, 42000
Saint Etienne, France, 42100
Saint Flour, France, 15100
Saint Jacques de La Lande, France, 35136
Saint Lo, France, 50000
Saint Nazaire, France, 44600
Saint Pierre de Coutances, France, 50200
Saint Quentin, France, 02100
Saint-affrique, France, 12400
Saint-etienne, France, 42000
Saint-malo, France, 35400
Saint-mande, France, 94160
Sainte Maxime, France, 83120
Saintes, France, 17100
Sarrebourg, France, 57400
Sartrouville, France, 78500
Sedan, France, 08200
Selestat, France, 67600
Senlis, France, 60300
Strasbourg, France, 67000
Strasbourg, France, 67100
Tassin La Demi-lune, France, 69160
Thionville, France, 57100
Toulon, France, 83000
Toulouse, France, 31077
Toulouse, France, 31000
Toulouse, France, 31400
Tourcoing, France, 59200
Tournon Sur Rhone, France, 07300
Tours, France, 37000
Valenciennes, France, 59300
Vandoeuvre-les-nancy, France, 54500
Vence, France, 06140
Venissieux, France, 69200
Vernet Les Bains, France, 66820
Villeneuve-sur-lot, France, 47300
Villeurbanne, France, 69100
Vincennes, France, 94300
Sponsors and Collaborators
Hoffmann-La Roche
GlaxoSmithKline
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545480     History of Changes
Other Study ID Numbers: ML19358
Study First Received: October 16, 2007
Last Updated: October 6, 2014
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Diphosphonates
Ibandronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014