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

Postmenopausal Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598440
• Other study ID #: MA17843
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2015
• Last updated: November 1, 2016
• Start date: March 2004
• Est. completion date: May 2005

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Alendronate
Participants wil receive once-weekly oral alendronate (70 mg tablet)
• Ibandronate
Participants wil receive once-monthly oral ibandronate (150 mg tablet)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate		Up to 6 months	No
Secondary	Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.		Up to 6 months	No
Secondary	Incidence of adverse events		Up to approximately 1 year	No