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

NCT00545779 | Completed Phase 3 Results

• 1 other identifier: ML20430
• Study Type: interventional
• Target: 677
• Locations: 6 countries
• Sites: 32

Brief Summary

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.

Conditions

Post-Menopausal Osteoporosis

Outcome Measures

Primary Outcomes (3)

• 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: 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.

  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 Outcomes (7)

• 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

  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

Study Arms (1)

Ibandronate

EXPERIMENTAL

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

Interventions

Ibandronate DRUG

150 mg orally once monthly for 6 months

Also known as: [Bonviva/Boniva]

Ibandronate

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (32)

Unknown Facility

Tirana, Albania

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Banja Luka, 78000, Bosnia and Herzegovina

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Sarajevo, 71 000, Bosnia and Herzegovina

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Sarajevo, 71000, Bosnia and Herzegovina

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Tuzla, 75000, Bosnia and Herzegovina

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Rijeka, 51000, Croatia

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Slavonski Brod, 35000, Croatia

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Split, 21000, Croatia

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Zagreb, 10000, Croatia

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Skopje, North Macedonia

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Belgrade, 11000, Serbia

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Niška Banja, 18205, Serbia

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Novi Sad, 21000, Serbia

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Adana, 01330, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Ankara, 06550, Turkey (Türkiye)

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Antalya, 07070, Turkey (Türkiye)

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Aydin, 09100, Turkey (Türkiye)

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Bursa, 16059, Turkey (Türkiye)

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Denizli, 20020, Turkey (Türkiye)

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Erzurum, 25240, Turkey (Türkiye)

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Gaziantep, 27310, Turkey (Türkiye)

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Istanbul, 34300, Turkey (Türkiye)

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Istanbul, 34303, Turkey (Türkiye)

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Istanbul, 35340, Turkey (Türkiye)

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Istanbul, 81190, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Kayseri, 38039, Turkey (Türkiye)

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Konya, 42080, Turkey (Türkiye)

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Manisa, 45200, Turkey (Türkiye)

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Samsun, 55139, Turkey (Türkiye)

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Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: December 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 28, 2016
• Results First Posted: October 28, 2016

Record last verified: 2016-09

Locations

CR (4); AL (1); SE (3); BO (4); NO (1); TU (19)