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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00129623
First received: August 11, 2005
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 1 year
Placebo Comparator: 2 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
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: 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
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23294
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: NCT00129623     History of Changes
Other Study ID Numbers: BA18492
Study First Received: August 11, 2005
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 August 28, 2014