PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

Roche

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02598453

ML18058

Details and patient eligibility

About

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.

Enrollment: 545 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with postmenopausal osteoporosis or osteopenia
• Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)

Exclusion criteria

• Inability to stand or sit upright for 60 minutes
• Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
• Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy
• Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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545 participants in 2 patient groups

Ibandronate IV

Experimental group

Description:

Participants will receive ibandronate 3 mg IV once every 3 months

Treatment:

Drug: Ibandronate

Ibandronate Oral

Experimental group

Description:

Participants will receive ibandronate 150 milligrams (mg) tablet once monthly

Treatment:

Drug: Ibandronate