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DIVA Study - A Study of Different Regimens of Intravenous Administration of 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:
NCT00048074
First received: October 24, 2002
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.


Condition Intervention Phase
Post-Menopausal Osteoporosis
 Drug: ibandronate [Bonviva/Boniva]
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD) \n\n [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative change in mean lumbar spine BMD\n [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Relative and absolute change in total hip, trochanter, femoral neck BMD [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Percentage of responders [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in fastin serum CTX [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 1395
Study Start Date: May 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
2mg iv every 2 months
Experimental: 2 Drug: ibandronate [Bonviva/Boniva]
2.5mg po daily
Experimental: 3 Drug: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
Active Comparator: 4 Drug: ibandronate [Bonviva/Boniva]
2.5mg po daily

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women 55-80 years of age;
  • post-menopausal for >=5 years;
  • ambulatory.

Exclusion Criteria:

  • malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
  • breast cancer within the previous 20 years;
  • allergy to bisphosphonates;
  • previous treatment with an intravenous bisphosphonate at any time;
  • previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048074

  Show 64 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048074     History of Changes
Other Study ID Numbers: BM16550
Study First Received: October 24, 2002
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013