A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

Roche

Status and phase: Completed; Phase 4

Conditions: Post Menopausal Osteoporosis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02598934

ML18057

Details and patient eligibility

About

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Enrollment: 308 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women newly diagnosed with postmenopausal osteoporosis
• Naive to prior bisphosphonate therapy

Exclusion criteria

• Inability to stand or sit upright for at least 60 minutes
• Inability to swallow a tablet whole
• Hypersensitivity to any component of ibandronate
• Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
• Other osteoporosis drug within last 3 months
• Malignant disease diagnosed within previous 10 years, except resected basal cell cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

Ibandronate Group 1

Experimental group

Description:

Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.

Treatment:

Drug: Ibandronate

Ibandronate Group 2

Experimental group

Description:

Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.

Treatment:

Drug: Ibandronate