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A Study of Adherence to Once Monthly Bonviva (Ibandronate) 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: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using serum CTX and communication of results at 3 months, on adherence to once monthly Bonviva (150mg po) in women with post-menopausal osteoporosis supported by PRP. Patients 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, and the target sample size is 500+ individuals.


Condition Intervention Phase
Post-Menopausal Osteoporosis
 Drug: ibandronate [Bonviva/Boniva]
 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:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction by OPSAT-Q and OPPS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Serum CTX levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 717
Study Start Date: May 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (+ feedback)
Active Comparator: 2 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ambulatory, post-menopausal women with osteoporosis;
  • 55-85 years of age;
  • eligible for bisphosphonate treatment;
  • naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake >= 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
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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545363     History of Changes
Other Study ID Numbers: ML19982
Study First Received: October 16, 2007
Last Updated: May 23, 2013
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013