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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545363

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Ibandronic acid Ibandronate sodium

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 Completion Date:	July 2008

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 6 months (+ feedback)
2: Active Comparator	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, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19982
Study First Received:	October 16, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00545363 History of Changes
Health Authority:	Slovenia: Agencija Republike Slovenije za zdravila in Medicinske Pripomocke

Additional relevant MeSH terms:

Ibandronic acid
Musculoskeletal Diseases
Physiological Effects of Drugs
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010