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

Roche

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545363

ML19982

2005-005529-74 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 716 patients

Sex: Female

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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716 participants in 2 patient groups

Bone Marker Feedback (BMF) Participants

Experimental group

Description:

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.

Treatment:

Drug: Ibandronate

No BMF Participants

Active Comparator group

Description:

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.

Treatment:

Drug: Ibandronate