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Completed

NCT Number: NCT02598440

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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alendronate

Drug

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

Ibandronate

Drug

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

Other names: Bonviva

Primary outcomes

  1. Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate

    Time frame: Up to 6 months

Secondary outcomes

  1. Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.

    Time frame: Up to 6 months

  2. Incidence of adverse events

    Time frame: Up to approximately 1 year

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 5, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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