A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01290094
First received: January 20, 2011
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This single arm, open label study will assess the efficacy and safety of and com pliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve pa tients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva a t a dose of 3 mg intravenously every three months. Anticipated time on study tre atment is 12 months with a follow-up of 12 months.


Condition Intervention Phase
Post-Menopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: Mean change in lumbar spine and hip bone mineral density (BMD) from baseline [ Time Frame: from baseline to Month 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance: percentage of patients that have received all planned study medication [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Correlation of patient's profile parameters (age, year since menopause, fracture history, BMD at baseline) with compliance [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: April 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: ibandronate [Bonviva/Boniva]
3 mg intravenously every 3 months

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients, > 50 years of age
  • Diagnosed osteoporosis
  • Bone mineral density < minus 2.5 SD or osteoporotic fracture
  • At least 3 years after menopause

Exclusion Criteria:

  • Impaired renal function
  • Contra-indication to Calcium or Vitamin D therapy
  • Previous or current treatment with biphosphonates
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290094

Locations
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajewo, Bosnia and Herzegovina, 71000
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: NCT01290094     History of Changes
Other Study ID Numbers: ML25399
Study First Received: January 20, 2011
Last Updated: October 13, 2014
Health Authority: Bosnia and Herzegovina: Agency for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 21, 2014