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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01128257
First Posted: May 21, 2010
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128257


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01128257     History of Changes
Other Study ID Numbers: ML22927
First Submitted: May 3, 2010
First Posted: May 21, 2010
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic acid
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs