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

August 17, 2015 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

596

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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
      • DAX, France, 40100
      • Davezieux, France, 07430
      • 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, 13012
      • Marseille, France, 13015
      • 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, 75014
      • Paris, France, 75015
      • Paris, France, 75010
      • Paris, France, 75007
      • Paris, France, 75020
      • Paris, France, 75011
      • Paris, France, 75004
      • Paris, France, 75008
      • Paris, France, 75017
      • Paris, France, 75116
      • 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, 67100
      • Strasbourg, France, 67000
      • Tassin La Demi-lune, France, 69160
      • Thionville, France, 57100
      • Toulon, France, 83000
      • Toulouse, France, 31000
      • Toulouse, France, 31077
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (with feedback)
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (without feedback)
Active Comparator: 2
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (with feedback)
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (without feedback)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences between groups in persistence
Time Frame: 6 months
6 months
QoL and patient satisfaction
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19358

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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