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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00129623

Purpose

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Post-Menopausal Osteopenia	Drug: ibandronate [Bonviva/Boniva] Drug: Placebo	Phase IV

MedlinePlus related topics: Menopause

Drug Information available for: Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind,Placebo-Controlled,Randomized, Multicenter Study to Assess the Efficiency and Safety of Oral Ibandronate 150 mg Once Monthly in Postmenopausal Women With Osteopenia

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Relative change in mean lumbar spine bone mineral density (BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute change in mean lumbar spine BMD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Relative and absolute change in mean proximal femur BMD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of responders [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Relative and absolute change in serum CTX [ Time Frame: 12 months ] [ Designated as safety issue: No ]
AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:

160

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 1 year
2: Placebo Comparator	Drug: Placebo po monthly for 1 year

Eligibility

Ages Eligible for Study:	45 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

women 45-60 years of age;
post-menopausal;
ambulatory.

Exclusion Criteria:

vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
low-trauma osteoporotic fracture in any other bone;
breast cancer diagnosed within last 20 years;
other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
treatment with any bisphosphonate within last 2 years;
treatment with other drugs affecting bone metabolism within last 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129623

Locations

United States, Colorado

LAKEWOOD, Colorado, United States, 80227
United States, Florida

STUART, Florida, United States, 34996
United States, Maryland

BETHESDA, Maryland, United States, 20817
United States, Michigan

DETROIT, Michigan, United States, 48236
United States, Missouri

ST LOUIS, Missouri, United States, 63110
United States, Nebraska

OMAHA, Nebraska, United States, 68131
United States, New Mexico

ALBUQUERQUE, New Mexico, United States, 87106
United States, Ohio

CINCINNATI, Ohio, United States, 45224
United States, Oregon

PORTLAND, Oregon, United States, 97213
United States, Texas

AMARILLO, Texas, United States, 79124
United States, Virginia

RICHMOND, Virginia, United States, 23294

NORFOLK, Virginia, United States, 23502

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA18492
Study First Received:	August 11, 2005
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00129623
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ibandronic acid
Musculoskeletal Diseases
Bone Diseases, Metabolic
Bone Diseases
Menopause

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009