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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: September 9, 2016
Last verified: September 2016
  Purpose
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants 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
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 'Open, Prospective, Multi-center, Two-part Study of Patient Preference With Monthly Ibandronate Therapy in Women With Postmenopausal Osteoporosis Switched From Once-daily or Once Weekly Alendronate or Risendronate - BONCURE (BONviva for Current Bisphosphonate Users - Regional European Trial)'

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ) [ Time Frame: Visit 0 (less than or equal to [<=] Day -30) ] [ Designated as safety issue: No ]

    The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option.

    In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:

    1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.
    2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.
    3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication.

  • Percentage of Participants Who Reported Preference for Monthly Ibandronate [ Time Frame: Visit 0 (<= Day -30) ] [ Designated as safety issue: No ]
    Percentage of participants who reported preference for monthly ibandronate were reported.

  • Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.


Secondary Outcome Measures:
  • Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ [ Time Frame: Visit 0 (<= Day -30) ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

    Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:

    1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule
    2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication
    3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication

  • Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B [ Time Frame: Visit 0 (<= Day -30) ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
  • Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1-6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11-16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction.


Enrollment: 677
Study Start Date: December 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibandronate
Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
Drug: Ibandronate
150 mg orally once monthly for 6 months
Other Name: [Bonviva/Boniva]

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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: NCT00545779

Locations
Albania
Tirana, Albania
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71 000
Sarajevo, Bosnia and Herzegovina, 71000
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
Serbia
Belgrade, Serbia, 11000
Niska Banja, Serbia, 18205
Novi Sad, Serbia, 21000
Turkey
Adana, Turkey, 01330
Ankara, Turkey, 06100
Ankara, Turkey, 06550
Antalya, Turkey, 07070
Aydin, Turkey, 09100
Bursa, Turkey, 16059
Denizli, Turkey, 20020
Erzurum, Turkey, 25240
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34300
Istanbul, Turkey, 34303
Istanbul, Turkey, 35340
Istanbul, Turkey, 81190
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545779     History of Changes
Other Study ID Numbers: ML20430 
Study First Received: October 16, 2007
Results First Received: July 19, 2016
Last Updated: September 9, 2016
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on December 02, 2016