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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01290094
First Posted: February 4, 2011
Last Update Posted: August 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Correlation Coefficient of Participant's Profile With Compliance [ Time Frame: Baseline up to Month 12 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 20, 2011
First Posted: February 4, 2011
Results First Submitted: July 17, 2015
Results First Posted: August 13, 2015
Last Update Posted: August 13, 2015
Last Verified: June 2015

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