A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

Postmenopausal Osteoporosis Clinical Trial

Official title:

A Prospective, Open-Label, Multi-Center, Two-Part Study to Investigate Patient Satisfaction With Monthly Dosed Ibandronate Therapy in Women With Post-Menopausal Osteoporosis or Osteopenia Transitioned From Once-Weekly Alendronate or Risendronate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604836
• Other study ID #: ML18056
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2015
• Last updated: November 1, 2016
• Start date: June 2004
• Est. completion date: April 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

This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1711
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (>=) 3 months

Exclusion Criteria:

• Inability to stand or sit upright for >=60 minutes

• Hypersensitivity to bisphosphonates

• Inability to swallow a tablet whole

• Malignant disease diagnosed within previous 10 years (except resected basal cell cancer).

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ibandronate
Film-coated oral ibandronate tablet (150 mg) once-monthly

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	Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)		Up to 30 days prior to baseline visit	No
Primary	Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate		6 months	No
Primary	Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate		6 months	No
Secondary	Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B		Screening visit	No
Secondary	Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate		6 months	No
Secondary	Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate		6 months	No
Secondary	Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance		6 months	No
Secondary	Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms		6 months	No
Secondary	Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)		6 months	No
Secondary	Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)		Baseline and 6 months	No
Secondary	Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B		Screening Visit	No
Secondary	Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate		6 months	No
Secondary	Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate		6 months	No
Secondary	Part B: Number of participants who have >= 80% compliance		6 months	No
Secondary	Part B: Number of participants who report an improvement in the GI symptoms		6 months	No
Secondary	Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)		6 months	No