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: July 17, 2015
Last verified: June 2015
  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:
  • Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Percent change was calculated as [(measure at time "t" minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.

  • Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.

  • Percent Change From Baseline in Mean Hip Bone BMD at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.

  • Percent Change From Baseline in Mean Hip BMD at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.


Secondary Outcome Measures:
  • Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 [ Time Frame: Baseline, Month 12, Month 24 ] [ Designated as safety issue: No ]
    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.

  • Percent Change From Baseline in Total Hip T-score at Month 12 and 24 [ Time Frame: Baseline, Month 12, Month 24 ] [ Designated as safety issue: No ]
    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.

  • Percentage of Participants Who Received All Planned Study Medication (Compliance) [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
  • Correlation Coefficient of Participant's Profile With Compliance [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
    Participant's profile included age, year since menopause, fracture history, and BMD at baseline.


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01290094     History of Changes
Other Study ID Numbers: ML25399 
Study First Received: January 20, 2011
Results First Received: July 17, 2015
Last Updated: July 17, 2015
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
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016