A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.

Post-Menopausal Osteopenia Clinical Trial

Official title:

A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545207
• Other study ID #: ML19357
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2007
• Last updated: January 25, 2017
• Est. completion date: September 2010

Study information

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

Clinical Trial Summary

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• post-menopausal women, aged 55-75 years;

• diagnosed osteopenia.

Exclusion Criteria:

• history of osteoporotic vertebral fracture;

• contraindication to ibandronate.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Post-Menopausal Osteopenia

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
150mg po monthly for 2 years
• Placebo
po monthly for 2 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trabecular BV/TV at distal radius of non-dominant arm		12 arms
Secondary	Trabecular BV/TV at distal radius of non-dominant arm		6 months and 2 years
Secondary	Bone density, trabecular BV/TV at distal tibia		6 months, 1 and 2 years
Secondary	Serum CTX		Intervals throughout study
Secondary	Lumbar hip and wrist BMD		1 and 2 years
Secondary	AEs and laboratory parameters		Throughout study