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

Post-Menopausal Osteoporosis Clinical Trial

Official title:

Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081653
• Other study ID #: MA17903
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2004
• Last updated: July 13, 2017
• Start date: May 2004
• Est. completion date: May 2008

Study information

• Verified date: July 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: May 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post-Menopausal Osteoporosis

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
150mg po monthly for 3 years
• ibandronate [Bonviva/Boniva]
100mg po monthly for 3 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Mexico,  Norway,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]).	Baseline and Months 12, 24 and 36
Primary	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]).	Baseline and Months 12, 24 and 36
Secondary	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).	Baseline and 12, 24 and 36 months
Secondary	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).	Baseline, 12, 24 and 36 months
Secondary	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.	Baseline, 6, 12, 24 and 36 months
Secondary	Relative Percent Change From Baseline of Trough Serum CTX	CTX is a measure of bone resorption and is measured as nanograms per milliliter (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.	Baseline, 6,12, 24 and 36 months