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

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

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.

Study Overview

• Status: Completed
• Conditions: Post Menopausal Osteoporosis
• Intervention / Treatment: Drug: ibandronate [Bonviva/Boniva]

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
  • Sarajewo, Bosnia and Herzegovina, 71000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Drug: ibandronate [Bonviva/Boniva]; 3 mg intravenously every 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 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.	Baseline, Month 12
Percent Change From Baseline in Mean Lumbar Spine BMD at 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.	Baseline, Month 24
Percent Change From Baseline in Mean Hip Bone BMD at 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.	Baseline, Month 12
Percent Change From Baseline in Mean Hip BMD at 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.	Baseline, Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 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.	Baseline, Month 12, Month 24
Percent Change From Baseline in Total Hip T-score at Month 12 and 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.	Baseline, Month 12, Month 24
Percentage of Participants Who Received All Planned Study Medication (Compliance)		Baseline up to Month 12
Correlation Coefficient of Participant's Profile With Compliance	Participant's profile included age, year since menopause, fracture history, and BMD at baseline.	Baseline up to Month 12

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Ibandronic Acid
• Other Study ID Numbers: ML25399