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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545363
• Other study ID #: ML19982
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: February 1, 2016
• Start date: May 2006
• Est. completion date: July 2008

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Agencija Republike Slovenije za zdravila in Medicinske Pripomocke
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 717
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (+ feedback)
• ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Hungary,  Latvia,  Poland,  Romania,  Russian Federation,  Slovakia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group		6 months	No
Secondary	Patient satisfaction by OPSAT-Q and OPPS		6 months	No
Secondary	Serum CTX levels		3 months	No
Secondary	AEs and laboratory parameters		Throughout study	No