A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)

A Randomized Open-Label Study to Investigate the Impact of Bone Marker Feedback at 3 Months on Adherence to Monthly Oral Bonviva in Women With Post-Menopausal Osteoporosis Supported by a Patient Relationship Program

This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: Ibandronate

• Study Type: Interventional
• Enrollment (Actual): 716
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1032
  • Budapest, Hungary, 1027
  • Budapest, Hungary, 1113
  • Békéscsaba, Hungary, 5600
  • Debrecen, Hungary, 4043
  • Miskolc, Hungary, 3529
  • Pecs, Hungary, 7624
  • Szeged, Hungary, 6720
  • Szekesfehervar, Hungary, 8000
  • Szombathely, Hungary, 9700
• Latvia
  • Liepaja, Latvia, 3400
  • Riga, Latvia, 1038
  • Riga, Latvia, 1004
  • Riga, Latvia, LV-1012
• Poland
  • Gliwice, Poland, 44-100
  • Krakow, Poland, 30-510
  • Lodz, Poland, 90-549
  • Poznan, Poland, 60-355
  • Warszawa, Poland, 02-637
  • Warszawa, Poland, 00-909
  • Warszawa, Poland, 00-719
  • Warszawa, Poland, 02-507
  • Wroclaw, Poland, 50-367
• Romania
  • Bucharest, Romania, 011172
  • Bucharest, Romania, 011364
  • Bucharest, Romania, 011461
  • Bucharest, Romania, 011863
  • Cluj-napoca, Romania, 400006
  • Constanta, Romania, 900709
  • Craiova, Romania, 300941
  • Timisoara, Romania, 300736
• Russian Federation
  • Ekaterinburg, Russian Federation, 620102
  • Irkutsk, Russian Federation, 664047
  • Moscow, Russian Federation, 111123
  • Moscow, Russian Federation, 129110
  • Moscow, Russian Federation, 117997
  • Moscow, Russian Federation, 127299
  • Moscow, Russian Federation, 117036
  • Moscow, Russian Federation, 125315
  • Moscow, Russian Federation, 101990
  • Moscow, Russian Federation, 115552
  • Moscow, Russian Federation, 127473
  • St Petersburg, Russian Federation, 199034
  • St Petersburg, Russian Federation, 190068
  • Voronezh, Russian Federation, 394066
  • Yaroslavl, Russian Federation, 150003
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
  • Bratislava, Slovakia, 826 06
  • Lubochna, Slovakia, 034 91
  • Piestany, Slovakia, 921 12
  • Presov, Slovakia, 080 01
• Slovenia
  • Ljubljana, Slovenia, 1525

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ambulatory, post-menopausal women with osteoporosis;
• eligible for bisphosphonate treatment;
• naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater than or equal to [>=] 6 months ago).

Exclusion Criteria:

• inability to stand or sit upright for at least 60 minutes;
• inability to swallow a tablet whole;
• hypersensitivity to bisphosphonates;
• treatment with drugs, or presence of active disease, known to influence bone metabolism;
• history of upper gastrointestinal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone Marker Feedback (BMF) Participants; Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, will receive BMF at Month 3. BMF will be given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A "BMF-form" will be provided to the physicians to allow offering the bone marker result in an easy way. Participants will be informed if their results are within or outside of the desired range. In addition, participants will also supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.	Drug: Ibandronate; Participants will receive ibandronate 150 mg QM orally for 6 months.; Other Names: Bonviva; Boniva
Active Comparator: No BMF Participants; Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants will be supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.	Drug: Ibandronate; Participants will receive ibandronate 150 mg QM orally for 6 months.; Other Names: Bonviva; Boniva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adherence to Treatment	Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores	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). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score.	At Month 6
Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score	OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.	At Month 6
Percent Change From Baseline in CTX Based on Adherence to Ibandronate	Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on CRF and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 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 24, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 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: ML19982; 2005-005529-74 (EudraCT Number)