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

Postmenopausal Osteoporosis Clinical Trial

Official title:

An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598453
• Other study ID #: ML18058
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2015
• Last updated: November 1, 2016
• Start date: January 2005
• Est. completion date: September 2006

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA:FDA
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months

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 who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate		12 months	No
Secondary	Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants		12 months	No
Secondary	Percentage of participants with GI events based on severity		Up to 10 months	No
Secondary	Percentage of participants who experienced a change in frequency and number of GI events		Up to 10 months	No