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

Phase 3

Completed

• Conditions: Post Menopausal Osteoporosis
• Interventions: Drug: ibandronate [Bonviva/Boniva]

• Registration Number: NCT01290094
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Study Start: 2011-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-06
• Results First Submitted: 2015-07-17
• Results First Submitted QC: 2015-07-17
• Last Update Submitted: 2015-07-17
• Results First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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

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Exclusion Criteria

• Impaired renal function
• Contra-indication to Calcium or Vitamin D therapy
• Previous or current treatment with biphosphonates

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	ibandronate [Bonviva/Boniva]	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12	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	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	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	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

Name	Time	Method
Correlation Coefficient of Participant's Profile With Compliance	Baseline up to Month 12	Participant's profile included age, year since menopause, fracture history, and BMD at baseline.
Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24	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	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)	Baseline up to Month 12