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

'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)'

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.

Study Overview

• Status: Completed
• Conditions: Post-Menopausal Osteoporosis
• Intervention / Treatment: Drug: Ibandronate

• Study Type: Interventional
• Enrollment (Actual): 677
• Phase: Phase 3

Contacts and Locations

Study 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: [Bonviva/Boniva]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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: I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.; More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.; Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication.	Visit 0 (less than or equal to [<=] Day -30)
Percentage of Participants Who Reported Preference for Monthly Ibandronate	Percentage of participants who reported preference for monthly ibandronate were reported.	Visit 0 (<= Day -30)
Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group	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.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ		Visit 0 (<= Day -30)
Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B	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: I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule; More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication; Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication	Month 6
Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B		Up to Month 6
Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B		Visit 0 (<= Day -30)
Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B		Baseline to Month 6
Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B		Month 6
Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B	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.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

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): October 28, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Ibandronic Acid
• Other Study ID Numbers: ML20430

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No