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A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 3, 2010
Last updated: November 1, 2016
Last verified: November 2016
This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.

Condition Intervention
Postmenopausal Osteoporosis Drug: alendronate Drug: ibandronate [Bonviva/Boniva]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Pain intensity and reduction in use of analgesics [ Time Frame: 12 months ]
  • Quality of life and patients satisfaction [ Time Frame: 12 months ]
  • Degree of patient's mobility [ Time Frame: 12 months ]
  • Incidence of new osteoporotic fractures [ Time Frame: 12 months ]
  • Controllability and management of therapy by the physician [ Time Frame: 12 months ]
  • Patient baseline characteristics [ Time Frame: 12 months ]
  • User friendliness [ Time Frame: 12 months ]
  • Safety: AEs and SAEs [ Time Frame: 12 months ]

Enrollment: 6054
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: ibandronate [Bonviva/Boniva]
As prescribed by physician
2 Drug: alendronate
As prescribed by physician


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female post-menopausal patients over the age of 55 years

Inclusion Criteria:

  • Adult patients, >/= 55 years of age
  • Postmenopausal osteoporosis
  • Patients who are in the opinion of the physician eligible to participate in this study

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01128257

Marburg, Germany, 35043
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01128257     History of Changes
Other Study ID Numbers: ML22927
Study First Received: May 3, 2010
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on August 18, 2017