Trial record 19 of 177 for:    "Osteoporosis, Postmenopausal"

A Study of Quarterly Intravenous 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:
NCT00493532
First received: June 27, 2007
Last updated: April 7, 2014
Last verified: April 2014
  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 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 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:


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 Start Date: June 2007
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, 00833
Kaohsiung, Taiwan, 807
Kaohsiung, Taiwan, 804
Taichung, Taiwan, 404
Taichung, Taiwan, 40705
Taichung, Taiwan, 402
Tainan, Taiwan, 704
Tainan, Taiwan, 710
Taipei, Taiwan, 00112
Taipei, Taiwan, 886
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
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: NCT00493532     History of Changes
Other Study ID Numbers: ML20882
Study First Received: June 27, 2007
Last Updated: April 7, 2014
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 April 17, 2014