A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Hoffmann-La Roche719 enrolled

Overview

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

719

Conditions

Post-Menopausal Osteoporosis

Interventions

ibandronate [Bonviva/Boniva]DRUG

150mg po monthly for 3 years

ibandronate [Bonviva/Boniva]DRUG

100mg po monthly for 3 years

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * successful completion of Bonviva study BM16549, with at least 75% compliance; * ambulatory. Exclusion Criteria: * malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed); * breast cancer diagnosed within the previous 22 years.

Locations (31)

Unnamed facility

Loma Linda, California, United States

Unnamed facility

Lakewood, Colorado, United States

Outcomes

Primary Outcomes

Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD

Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).

Time frame: Baseline and Months 12, 24 and 36

Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)

BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).

Time frame: Baseline and Months 12, 24 and 36

Secondary Outcomes

Absolute Change From Baseline in Mean Total Hip BMD

BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).

Time frame: Baseline and 12, 24 and 36 months

Relative Percent Change From Baseline in Mean Total Hip BMD

BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).

Time frame: Baseline, 12, 24 and 36 months

Absolute Change From Baseline of Trough Serum CTX

CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.

Time frame: Baseline, 6, 12, 24 and 36 months

Data from ClinicalTrials.gov

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