NCT02598934

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

A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Post Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Ibandronate	Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2015-11-06
• Last updated: 2016-03-09
• Results posted: 2016-03-09

Locations

53 sites across 2 countries: United States, Puerto Rico