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

A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02598440

Enrollment

341

Registered

2015-11-05

Start date

2004-03-31

Completion date

2005-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Brief summary

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.

Interventions

DRUGAlendronate

Participants wil receive once-weekly oral alendronate (70 mg tablet)

DRUGIbandronate

Participants wil receive once-monthly oral ibandronate (150 mg tablet)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate	Up to 6 months

Secondary

Measure	Time frame
Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.	Up to 6 months
Incidence of adverse events	Up to approximately 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026