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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01290094
First received: January 20, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment 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
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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
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: April 7, 2014
Health Authority: Bosnia and Herzegovina: Agency for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014