A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

Roche

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Alendronate; Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02598440

MA17843

Details and patient eligibility

About

This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.

Enrollment: 341 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ambulatory women
• Diagnosis of post-menopausal osteoporosis
• Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry

Exclusion criteria

• Inability to stand or sit in the upright position for greater than or equal to 60 minutes
• Allergy to bisphosphonates;
• Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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341 participants in 2 patient groups

Group A: Ibandronate Then Alendronate

Experimental group

Description:

Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks.

Treatment:

Drug: Ibandronate

Drug: Alendronate

Group B: Alendronate Then Ibandronate

Experimental group

Description:

Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months.

Treatment:

Drug: Ibandronate

Drug: Alendronate