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

This study has been completed.

First Received: October 16, 2007 Last Updated: May 13, 2009 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545090

Purpose

This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva

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:

SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	561
Study Completion Date:	June 2008

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 6 months

Eligibility

Ages Eligible for Study:	up to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients responding to oral monthly Bonviva during the BonAdAsia study;
willing to continue Bonviva treatment for a further 6 months.

Exclusion Criteria:

none specified.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545090

Locations

China

HONG KONG, China, 852
Indonesia

JAKARTA, Indonesia, 10430

MAKASSAR, Indonesia, 90174

SURABAYA, Indonesia, 60286
Philippines

MANILA, Philippines, 1015

QUEZON CITY, Philippines, 1100
Taiwan

TAICHUNG, Taiwan, 407

TAINAN, Taiwan, 704

CHANGHUA, Taiwan, 500

TAICHUNG, Taiwan, 404

TAOYUAN, Taiwan, 333

TAIPEI, Taiwan, 100

TAIPEI, Taiwan, 112
Thailand

KHON KAEN, Thailand, 40002

BANGKOK, Thailand, 10330

CHIANG MAI, Thailand, 50200

BANGKOK, Thailand, 10400

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19937
Study First Received:	October 16, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00545090 History of Changes
Health Authority:	Philippines: Department of Health

Additional relevant MeSH terms:

Ibandronic acid
Musculoskeletal Diseases
Physiological Effects of Drugs
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010