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

Post Menopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290094
• Other study ID #: ML25399
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2011
• Last updated: July 17, 2015
• Start date: April 2011
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia and Herzegovina: Agency for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post Menopausal Osteoporosis

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
3 mg intravenously every 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of Participants Who Received All Planned Study Medication (Compliance)		Baseline up to Month 12	No
Secondary	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	No