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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545090
First received: October 16, 2007
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Post-Menopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
Phase 4

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, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva

Resource links provided by NLM:


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 Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Hong Kong
Hong Kong, Hong Kong, 852
Indonesia
Jakarta, Indonesia, 10430
Makassar, Indonesia, 90174
Surabaya, Indonesia, 60286
Philippines
Manila, Philippines, 1015
Quezon City, Philippines, 1100
Taiwan
Changhua, Taiwan, 500
Taichung, Taiwan, 407
Taichung, Taiwan, 404
Tainan, Taiwan, 704
Taipei, Taiwan, 00112
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10330
Chiang Mai, Thailand, 50200
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545090     History of Changes
Other Study ID Numbers: ML19937
Study First Received: October 16, 2007
Last Updated: August 4, 2014
Health Authority: Philippines: 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 September 16, 2014