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SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
This study has been completed.
First Received: October 16, 2007   Last Updated: October 15, 2009   History of Changes
Sponsor: Hoffmann-La Roche
Collaborator: GlaxoSmithKline
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545480
  Purpose

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.


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

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Menopause Osteoporosis
Drug Information available for: Ibandronic acid Ibandronate sodium
U.S. FDA Resources

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 Completion Date: March 2009
Arms Assigned Interventions
1: Experimental Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (with feedback)
2: Active Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545480

  Hide Study Locations
Locations
France
LISIEUX, France, 14100
VILLEURBANNE, France, 69100
SAINT BRIEUC, France, 22000
MAROMME, France, 76150
LAVAL, France, 53000
STRASBOURG, France, 67000
MARTIGUES, France, 13500
ARLES, France, 13200
MONTPELLIER, France, 34090
CENON, France, 33150
RONCHIN, France, 59790
BESANCON, France, 25000
PARIS, France, 75010
ISTRES, France, 13800
SAINT JACQUES DE LA LANDE, France, 35136
CHELLES, France, 77000
DAX, France, 40100
ANGOULEME, France, 16000
HYERES, France, 83400
TOULON, France, 83000
LA TRINITÉ, France, 06340
SAINTE MAXIME, France, 83120
BORDEAUX, France, 33200
MARSEILLE, France, 13008
PLAN DE CUQUES, France, 13380
LIMOGES, France, 87100
SAINT-AFFRIQUE, France, 12400
SAINT-ETIENNE, France, 42000
PARIS, France, 75017
SARREBOURG, France, 57400
BOLBEC, France, 76210
SENLIS, France, 60300
DOLE, France, 39100
MONTGERON, France, 91240
GRENOBLE, France, 38000
SAINT ETIENNE, France, 42000
MONTBRISSON, France, 42600
LYON, France, 69002
NICE, France, 06000
OLORON, France, 64400
BAYONNE, France, 64100
SAINT LO, France, 50000
RONCHIN, France, 59790
BEZIERS, France, 34500
NIMES, France, 30900
MURET, France, 31600
TOULOUSE, France, 31400
AURILLAC, France, 15000
DECINES, France, 69150
PONT A MOUSSON, France, 54700
CHILLY-MAZARIN, France, 91380
QUIMPER, France, 29000
VERNET LES BAINS, France, 66820
SELESTAT, France, 67600
BELFORT, France, 90000
RENNES, France, 35000
OYONNAX, France, 01100
MARSEILLE, France, 13006
L'UNION, France, 31240
BEZIERS, France, 34500
LANGON, France, 33210
BORDEAUX, France, 33100
CARPENTRAS, France, 84200
BILLERE, France, 64140
ARMENTIERES, France, 59280
AMIENS, France, 80000
CHOISY LE ROI, France, 94600
PARIS, France, 75015
DAVEZIEUX, France, 07430
SAINT PIERRE DE COUTANCES, France, 50200
DIJON, France, 21000
ANGERS, France, 49100
MONTLUCON, France, 03100
LA ROCHE SUR YON, France, 85000
ANDERNOS LES BAINS, France, 33510
LOOS, France, 59120
LILLE, France, 59800
MILLAU, France, 12100
AIX LES BAINS, France, 73100
BREST, France, 29200
BILLERE, France, 64140
AVRANCHES, France, 50300
SAINT FLOUR, France, 15100
CHALON SUR SAONE, France, 71100
LAGNY-SUR-MARNE, France, 77400
THIONVILLE, France, 57100
LILLE, France, 59000
LAVAL, France, 53000
SAINT DOULCHARD, France, 18230
LANDIVISIAU, France, 29400
LE MANS, France, 72000
ANNECY, France, 74000
AUCH, France, 32000
CHARTRES, France, 28000
TOURS, France, 37000
TOURS, France, 37000
AVIGNON, France, 84000
MARSEILLE, France, 13012
ORMESSON SUR MARNE, France, 94490
NICE, France, 06000
CAEN, France, 14000
STRASBOURG, France, 67000
STRASBOURG, France, 67100
ROCHEFORT, France, 17300
NANCY, France, 54000
RUEIL-MALMAISON, France, 92500
BRUZ, France, 35170
TOULOUSE, France, 31077
PARIS, France, 75020
CHARENTON LE PONT, France, 94220
LILLE, France, 59000
CHALONS EN CHAMPAGNE, France, 51000
GRANVILLE, France, 50400
PARIS, France, 75020
LA ROCHELLE, France, 17000
PARIS, France, 75011
PARIS, France, 75008
PARIS, France, 75015
ANGERS, France, 49100
VANDOEUVRE-LES-NANCY, France, 54500
AMIENS, France, 80000
CAEN, France, 14000
MANDELIEU LA NAPOULE, France, 06210
LONGWY, France, 54400
ROQUEBRUNE CAP MARTIN, France, 06190
CAVAILLON, France, 84300
ANTIBES, France, 06600
MONTELIMAR, France, 26200
AURAY, France, 56400
LA ROCHELLE, France, 17000
MENNECY, France, 91540
SARTROUVILLE, France, 78500
SAINT ETIENNE, France, 42100
SAINTES, France, 17100
MIRIBEL, France, 01700
LYON, France, 69006
CLICHY, France, 92110
AMBOISE, France, 37400
NANTES, France, 44000
GOURDON, France, 46300
LILLE, France, 59800
MAISONS-ALFORT, France, 94700
TOULOUSE, France, 31000
GRENOBLE, France, 38000
LA MADELEINE, France, 59110
NOGENT LE ROTROU, France, 28400
SAINT JACQUES DE LA LANDE, France, 35136
MARSEILLE, France, 13015
CAGNES-SUR-MER, France, 06800
NEUILLY-SUR-SEINE, France, 92200
PARIS, France, 75014
TOURNON SUR RHONE, France, 07300
MULHOUSE, France, 68100
POITIERS, France, 86000
ALBERT, France, 80300
SEDAN, France, 08200
VENISSIEUX, France, 69200
LYON, France, 69007
PARIS, France, 75007
LYON, France, 69002
LAVAUR, France, 81500
ORLEANS, France, 45000
PUTEAUX, France, 92800
ROUEN, France, 76000
SAINT NAZAIRE, France, 44600
CANNES, France, 06400
AGEN, France, 47000
COLMAR, France, 68000
TOULOUSE, France, 31000
CLICHY, France, 92210
BEAUMONT S/OISE, France, 95260
REIMS, France, 51100
MEAUX, France, 77000
NOISY LE SEC, France, 93130
FONTENAY S/BOIS, France, 94120
VINCENNES, France, 94300
POISSY, France, 78302
CLAMART, France, 92140
ARCACHON, France, 33120
L'ISLE SUR SORGUE, France, 84800
ORTHEZ, France, 64300
MERIGNAC, France, 33700
LES MUREAUX, France, 78130
NARBONNE, France, 11000
VILLENEUVE-SUR-LOT, France, 47300
ANTONY, France, 92160
PARIS, France, 75116
BLANQUEFORT, France, 33290
MEYLAN, France, 38240
PERPIGNAN, France, 66000
SAINT-MALO, France, 35400
ISSY LES MOULINEAUX, France, 92130
AMIENS, France, 80094
LIBOURNE, France, 33500
PANTIN, France, 93500
PARIS, France, 75004
TOURCOING, France, 59200
TASSIN LA DEMI-LUNE, France, 69160
COLMAR, France, 68000
SAINT-MANDE, France, 94160
VENCE, France, 06140
CORNEBARRIEU, France, 31700
ANDREZIEUX BOUTHEON, France, 42160
FONTAINE, France, 38600
LE PERREUX SUR MARNE, France, 94170
VALENCIENNES, France, 59300
NANTES, France, 44000
TOURCOING, France, 59200
SAINT ETIENNE, France, 42000
MARIGNANE, France, 13700
ARGELES SUR MER, France, 66700
SAINT QUENTIN, France, 02100
CLERMONT-FERRAND, France, 63000
THIONVILLE, France, 57100
LORIENT, France, 56100
Sponsors and Collaborators
Hoffmann-La Roche
GlaxoSmithKline
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers: ML19358
Study First Received: October 16, 2007
Last Updated: October 15, 2009
ClinicalTrials.gov Identifier: NCT00545480     History of Changes
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

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

ClinicalTrials.gov processed this record on November 30, 2009



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