Clinical trial NCT00545779: BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
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)'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 677
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Visit 0 (less than or equal to [<=] Day -30)
measure: Percentage of Participants Who Reported Preference for Monthly Ibandronate
timeFrame: Visit 0 (<= Day -30)
measure: Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ
timeFrame: Visit 0 (<= Day -30)
measure: Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B
timeFrame: Month 6
measure: Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B
timeFrame: Up to Month 6
measure: Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B
timeFrame: Visit 0 (<= Day -30)
measure: Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B
timeFrame: Baseline to Month 6
measure: Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B
timeFrame: Month 6
measure: Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Tirana
country: Albania
city: Banja Luka
country: Bosnia and Herzegovina
city: Sarajevo
country: Bosnia and Herzegovina
city: Sarajevo
country: Bosnia and Herzegovina
city: Tuzla
country: Bosnia and Herzegovina
city: Rijeka
country: Croatia
city: Slavonski Brod
country: Croatia
city: Split
country: Croatia
city: Zagreb
country: Croatia
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Belgrade
country: Serbia
city: Niska Banja
country: Serbia
city: Novi Sad
country: Serbia
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Aydin
country: Turkey
city: Bursa
country: Turkey
city: Denizli
country: Turkey
city: Erzurum
country: Turkey
city: Gaziantep
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Konya
country: Turkey
city: Manisa
country: Turkey
city: Samsun
country: Turkey
city: Trabzon
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: