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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545363
First received: October 16, 2007
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Ibandronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Adherence to Treatment [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores [ Time Frame: At 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). 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.

  • Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score [ Time Frame: At Month 6 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in CTX Based on Adherence to Ibandronate [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 716
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00545363

  Show 52 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545363     History of Changes
Other Study ID Numbers: ML19982  2005-005529-74 
Study First Received: October 16, 2007
Results First Received: July 2, 2016
Last Updated: August 31, 2016
Health Authority: Slovenia: Agencija Republike Slovenije za zdravila in Medicinske Pripomocke

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 06, 2016