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BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545779
First received: October 16, 2007
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This single arm study will assess patient preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Patients currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify patients who may benefit from a monthly Bonviva regimen. Eligible patients will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg po. At the beginning and end of Bonviva treatment, all patients will complete an Osteoporosis Patient Satisfaction Questionnaire. 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: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 'An Open-label Study of Patient Preference With Monthly Bonviva Therapy in Women With Post-menopausal Osteoporosis Switched From Daily or Weekly Alendronate or Risendronate.'

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number and percentage of patients who prefer monthly Bonviva, compared with previous daily or weekly alendronate or risedronate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved satisfaction scores with Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • >=80% compliance with Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Choice of monthly reminders to take Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in GI symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 655
Study Start Date: December 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-menopausal women;
  • >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.

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;
  • abnormalities of the oesophagus, which delay oesophageal emptying.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545779

Locations
Albania
Tirana, Albania
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Sarajevo, Bosnia and Herzegovina, 71 000
Tuzla, Bosnia and Herzegovina, 75000
Croatia
Rijeka, Croatia, 51000
Slavonski Brod, Croatia, 35000
Split, Croatia, 21000
Zagreb, Croatia, 10000
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Serbia
Belgrade, Serbia, 11000
Niska Banja, Serbia, 18250
Novi Sad, Serbia, 21000
Turkey
Adana, Turkey, 01330
Ankara, Turkey, 06550
Ankara, Turkey, 06100
Antalya, Turkey, 07070
Aydin, Turkey, 09100
Bursa, Turkey, 16059
Denizli, Turkey, 20020
Erzurum, Turkey, 25240
Gaziantep, Turkey, 27310
Istanbul, Turkey, 35340
Istanbul, Turkey, 81190
Istanbul, Turkey, 34303
Istanbul, Turkey, 34300
Izmir, Turkey, 35100
Kayseri, Turkey, 38039
Konya, Turkey, 42080
Manisa, Turkey, 45200
Samsun, Turkey, 55139
Trabzon, Turkey, 61080
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545779     History of Changes
Other Study ID Numbers: ML20430
Study First Received: October 16, 2007
Last Updated: June 3, 2013
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013