A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

Roche

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02604836

ML18056

Details and patient eligibility

About

This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.

Enrollment: 1,711 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (>=) 3 months

Exclusion criteria

• Inability to stand or sit upright for >=60 minutes
• Hypersensitivity to bisphosphonates
• Inability to swallow a tablet whole
• Malignant disease diagnosed within previous 10 years (except resected basal cell cancer).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,711 participants in 1 patient group

Ibandronate

Experimental group

Description:

Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.

Treatment:

Drug: Ibandronate