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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01128257
First received: May 3, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  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
Post-Menopausal Osteoporosis
 Drug: ibandronate [Bonviva/Boniva]
Drug: alendronate

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity and reduction in use of analgesics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life and patients satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Degree of patient's mobility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of new osteoporotic fractures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Controllability and management of therapy by the physician [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient baseline characteristics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • User friendliness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety: AEs and SAEs [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   55 Years and older
Genders 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:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128257

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01128257     History of Changes
Other Study ID Numbers: ML22927
Study First Received: May 3, 2010
Last Updated: June 3, 2013
Health Authority: Germany: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013