Post Menopausal OsteoporosisPhase 4NCT00545480
SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
A Phase 4 study testing ibandronate [Bonviva/Boniva] in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 190 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Post Menopausal Osteoporosis
- What is being tested?
- ibandronate [Bonviva/Boniva]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 190 sitesFrance
- Study dates
- Jul 2006to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ambulatory, post-menopausal women who would benefit from bisphosphonate treatment;
- >55 years of age;
- naive to bisphosphonate therapy, or lapsed bisphosphonate users >=6 months.
Who cannot join
- 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.
Trial locations and contacts
190 sites in 1 country.
190 sites in 1 country
France190 sites
Study site
Agen, 47000
Study site
Aix-les-Bains, 73100
Study site
Albert, 80300
Study site
Amboise, 37400
Study site
Amiens, 80000
Study site
Amiens, 80094
Study site
Andernos-les-Bains, 33510
Study site
Andrézieux-Bouthéon, 42160
Study site
Angers, 49100
Study site
Angoulême, 16000
Study site
Annecy, 74000
Study site
Antibes, 06600
Study site
Antony, 92160
Study site
Arcachon, 33120
Study site
Argeles, 66700
Study site
Arles, 13200
Study site
Armentières, 59280
Study site
Auch, 32000
Study site
Auray, 56400
Study site
Aurillac, 15000
Study site
Avignon, 84000
Study site
Avranches, 50300
Study site
Bayonne, 64100
Study site
Beaumont S/oise, 95260
Study site
Belfort, 90000
Study site
Besançon, 25000
Study site
Béziers, 34500
Study site
Billère, 64140
Study site
Blanquefort, 33290
Study site
Bolbec, 76210
Study site
Bordeaux, 33100
Study site
Bordeaux, 33200
Study site
Brest, 29200
Study site
Bruz, 35170
Study site
Caen, 14000
Study site
Cagnes-sur-Mer, 06800
Study site
Cannes, 06400
Study site
Carpentras, 84200
Study site
Cavaillon, 84300
Study site
Cenon, 33150
Study site
Chalon-sur-Saône, 71100
Study site
Châlons-en-Champagne, 51000
Study site
Charenton-le-Pont, 94220
Study site
Chartres, 28000
Study site
Chelles, 77000
Study site
Chilly-Mazarin, 91380
Study site
Choisy-le-Roi, 94600
Study site
Clamart, 92140
Study site
Clermont-Ferrand, 63000
Study site
Clichy, 92110
Study site
Clichy, 92210
Study site
Colmar, 68000
Study site
Cornebarrieu, 31700
Study site
Davézieux, 07430
Study site
Dax, 40100
Study site
Décines-Charpieu, 69150
Study site
Dijon, 21000
Study site
Dole, 39100
Study site
Fontaine, 38600
Study site
Fontenay S/bois, 94120
Study site
Gourdon, 46300
Study site
Granville, 50400
Study site
Grenoble, 38000
Study site
Hyères, 83400
Study site
Issy-les-Moulineaux, 92130
Study site
Istres, 13800
Study site
L'isle Sur Sorgue, 84800
Study site
L'Union, 31240
Study site
La Madeleine, 59110
Study site
La Roche-sur-Yon, 85000
Study site
La Rochelle, 17000
Study site
La Trinité, 06340
Study site
Lagny-sur-Marne, 77400
Study site
Landivisiau, 29400
Study site
Langon, 33210
Study site
Laval, 53000
Study site
Lavaur, 81500
Study site
Le Mans, 72000
Study site
Le Perreux-sur-Marne, 94170
Study site
Les Mureaux, 78130
Study site
Libourne, 33500
Study site
Lille, 59000
Study site
Lille, 59800
Study site
Limoges, 87100
Study site
Lisieux, 14100
Study site
Longwy, 54400
Study site
Loos, 59120
Study site
Lorient, 56100
Study site
Lyon, 69002
Study site
Lyon, 69006
Study site
Lyon, 69007
Study site
Maisons-Alfort, 94700
Study site
Mandelieu-la-Napoule, 06210
Study site
Marignane, 13700
Study site
Maromme, 76150
Study site
Marseille, 13006
Study site
Marseille, 13008
Study site
Marseille, 13012
Study site
Marseille, 13015
Study site
Martigues, 13500
Study site
Meaux, 77000
Study site
Mennecy, 91540
Study site
Mérignac, 33700
Study site
Meylan, 38240
Study site
Millau, 12100
Study site
Miribel, 01700
Study site
Montbrisson, 42600
Study site
Montélimar, 26200
Study site
Montgeron, 91240
Study site
Montluçon, 03100
Study site
Montpellier, 34090
Study site
Mulhouse, 68100
Study site
Muret, 31600
Study site
Nancy, 54000
Study site
Nantes, 44000
Study site
Narbonne, 11000
Study site
Neuilly-sur-Seine, 92200
Study site
Nice, 06000
Study site
Nîmes, 30900
Study site
Nogent-le-Rotrou, 28400
Study site
Noisy-le-Sec, 93130
Study site
Oloron-Sainte-Marie, 64400
Study site
Orléans, 45000
Study site
Ormesson-sur-Marne, 94490
Study site
Orthez, 64300
Study site
Oyonnax, 01100
Study site
Pantin, 93500
Study site
Paris, 75004
Study site
Paris, 75007
Study site
Paris, 75008
Study site
Paris, 75010
Study site
Paris, 75011
Study site
Paris, 75014
Study site
Paris, 75015
Study site
Paris, 75017
Study site
Paris, 75020
Study site
Paris, 75116
Study site
Perpignan, 66000
Study site
Plan-de-Cuques, 13380
Study site
Poissy, 78302
Study site
Poitiers, 86000
Study site
Pont-à-Mousson, 54700
Study site
Puteaux, 92800
Study site
Quimper, 29000
Study site
Reims, 51100
Study site
Rennes, 35000
Study site
Rochefort, 17300
Study site
Ronchin, 59790
Study site
Roquebrune-Cap-Martin, 06190
Study site
Rouen, 76000
Study site
Rueil-Malmaison, 92500
Study site
Saint-Affrique, 12400
Study site
Saint-Brieuc, 22000
Study site
Saint-Doulchard, 18230
Study site
Saint-Etienne, 42000
Study site
Saint-Etienne, 42100
Study site
Saint-Flour, 15100
Study site
Saint-Jacques-de-la-Lande, 35136
Study site
Saint-Lô, 50000
Study site
Saint-Mandé, 94160
Study site
Saint-Nazaire, 44600
Study site
Saint-Pierre-de-Coutances, 50200
Study site
Saint-Quentin, 02100
Study site
Sainte-Maxime, 83120
Study site
Saintes, 17100
Study site
Sarrebourg, 57400
Study site
Sartrouville, 78500
Study site
Sedan, 08200
Study site
Sélestat, 67600
Study site
Senlis, 60300
Study site
St-Malo, 35400
Study site
Strasbourg, 67000
Study site
Strasbourg, 67100
Study site
Tassin-la-Demi-Lune, 69160
Study site
Thionville, 57100
Study site
Toulon, 83000
Study site
Toulouse, 31000
Study site
Toulouse, 31077
Study site
Toulouse, 31400
Study site
Tourcoing, 59200
Study site
Tournon-sur-Rhône, 07300
Study site
Tours, 37000
Study site
Valenciennes, 59300
Study site
Vandœuvre-lès-Nancy, 54500
Study site
Vence, 06140
Study site
Vénissieux, 69200
Study site
Vernet-les-Bains, 66820
Study site
Villeneuve-sur-Lot, 47300
Study site
Villeurbanne, 69100
Study site
Vincennes, 94300
About this 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.
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.
- Conditions
- Post Menopausal Osteoporosis
- Being tested
- ibandronate [Bonviva/Boniva]
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibandronate [Bonviva/Boniva]Drug
150mg po monthly for 12 months (with feedback)
ibandronate [Bonviva/Boniva]Drug
150mg po monthly for 12 months (without feedback)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronate [Bonviva/Boniva] |
| 2 | Active comparator | Not described Receives: Drug: ibandronate [Bonviva/Boniva] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group
Measured: 12 months
Secondary outcomes (2)
Differences between groups in persistence
Measured: 6 months
QoL and patient satisfaction
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startJul 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Menopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545480
- Sponsor's protocol ID
- ML19358
- Status last verified
- Aug 2015
- First submitted
- 16 Oct 2007
- Last updated
- 18 Aug 2015
- Results posted
- No
Publications
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.
PubMed 21703900
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00545480
- Acronym / sponsor ID
- ML19358
- Conditions
- Post Menopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ibandronate [Bonviva/Boniva] |
| 2 | Active comparator | Drug: ibandronate [Bonviva/Boniva] |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ambulatory, post-menopausal women who would benefit from bisphosphonate treatment;
- >55 years of age;
- naive to bisphosphonate therapy, or lapsed bisphosphonate users >=6 months.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibandronate [Bonviva/Boniva]150mg po monthly for 12 months (with feedback) | Drug | 1 |
| ibandronate [Bonviva/Boniva]150mg po monthly for 12 months (without feedback) | Drug | 2 |
Primary outcome
Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group
Time frame: 12 months
2 secondary outcomes
Differences between groups in persistence
Time frame: 6 months
QoL and patient satisfaction
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Derived from this study: PubMed 21703900Roux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
190 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ibandronate [Bonviva/Boniva] in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 190 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 190 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00545480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015; AzTrials last refreshed its copy on 2 Nov 2026.