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Completed

NCT Number: NCT01128257

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

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.

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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

Age range

55 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Marburg, 35043, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Alendronate

Drug

As prescribed by physician

ibandronate [Bonviva/Boniva]

Drug

As prescribed by physician

Primary outcomes

  1. 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 outcomes

  1. Pain intensity and reduction in use of analgesics

    Time frame: 12 months

  2. Quality of life and patients satisfaction

    Time frame: 12 months

  3. Degree of patient's mobility

    Time frame: 12 months

  4. Incidence of new osteoporotic fractures

    Time frame: 12 months

  5. Controllability and management of therapy by the physician

    Time frame: 12 months

  6. Patient baseline characteristics

    Time frame: 12 months

  7. User friendliness

    Time frame: 12 months

  8. Safety: AEs and SAEs

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 21, 2010
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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