A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00493532

Purpose

This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Mean change (%) in spinal BMD [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in hip BMD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean change in Serum CTX [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Mean change in hip and spinal BMD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
AEs and clinical fractures [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Percentage change from baseline in OPSAT-Q [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	100
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: ibandronate [Bonviva/Boniva] 3mg iv every 3 months

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

post-menopausal women with osteoporosis;
<=80 years of age;
naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year.

Exclusion Criteria:

metabolic bone disease other than post-menopausal osteoporosis;
treatment with other drugs affecting bone metabolism within last 6 months;
previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493532

Locations

Taiwan

Chai Yi, Taiwan, 613

Changhua, Taiwan, 500

Kaohsiung, Taiwan, 833

Kaohsiung, Taiwan, 804

Kaohsiung, Taiwan, 807

Taichung, Taiwan, 404

Taichung, Taiwan, 402

Tainan, Taiwan, 710

Tainan, Taiwan, 704

Taipei, Taiwan, 886

Taipei, Taiwan, 112

Taipei, Taiwan, 100

Taiwan, Taiwan, 407

Taoyuan, Taiwan, 333

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00493532 History of Changes
Other Study ID Numbers:	ML20882
Study First Received:	June 27, 2007
Last Updated:	March 15, 2011
Health Authority:	Taiwan: Department of Health

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012