A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00503113
First received: July 17, 2007
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. 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]
Drug: Alendronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: Yes ]
    The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.


Secondary Outcome Measures:
  • Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: Yes ]
    Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.

  • Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: Yes ]
    Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.

  • Relative Change From Baseline in Actual GFR (Using CG Formula) [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: Yes ]
    Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.

  • Absolute Change From Baseline in Mean Serum Creatinine. [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: Yes ]
  • Relative Change From Baseline in Mean Serum Creatinine. [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: Yes ]
  • Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: Yes ]
  • Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: Yes ]
    The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.


Enrollment: 801
Study Start Date: July 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
3mg intravenous (iv) injection every 3 months
Experimental: 2 Drug: ibandronate [Bonviva/Boniva]
3mg intravenous (iv) infusion every 3 months
Active Comparator: 3 Drug: Alendronate
70mg per oral (po) weekly

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients, >=60 years of age;
  • >=5 years postmenopausal;
  • confirmed osteoporosis, at increased risk for renal disease.

Exclusion Criteria:

  • inability to stand or sit upright for 30 minutes;
  • hypersensitivity to bisphosphonates;
  • malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
  • previous administration of an i.v. bisphosphonate;
  • oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;
  • history of major upper gastrointestinal disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503113

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Riverside, California, United States, 92505
United States, Colorado
Lakewood, Colorado, United States, 80227
United States, Florida
West Palm Beach, Florida, United States, 33401
United States, Georgia
Gainesville, Georgia, United States, 30501
United States, Kansas
Topeka, Kansas, United States, 66604
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Morehead City, North Carolina, United States, 28557
United States, North Dakota
Bismarck, North Dakota, United States, 58501
Fargo, North Dakota, United States, 58103
United States, Ohio
Cincinnati, Ohio, United States, 45224
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, Virginia
Norfolk, Virginia, United States, 23502
Argentina
Buenos Aires, Argentina, C1128AAF
Buenos Aires, Argentina, C1405BCH
Buenos Aires, Argentina, C1012-CFed
Buenos Aires, Argentina, B1878DVB
Buenos Aires, Argentina, C1425 AWC
Buenos Aires, Argentina, C1425AGC
Buenos Aires, Argentina, C1117ABH
Cordoba, Argentina, X5000BNB
Santa Fe, Argentina, 2000
Brazil
Brasilia, Brazil, 71625-009
Curitiba, Brazil, 80030-110
Goiania, Brazil, 74110-120
Porto Alegre, Brazil, 90610-000
Rio de Janeiro, Brazil, 22271-100
Sao Paulo, Brazil, 04266-010
Vitoria, Brazil, 29055-450
Mexico
Guadalajara, Mexico, 44629
Mexico City, Mexico, 11000
Monterrey, Mexico, 64460
Obregon, Mexico, 85000
San Jerónimo Chicahualco, Mexico, 52170
South Africa
Durban, South Africa, 3630
Johannesburg, South Africa, 2196
Parow, South Africa, 7500
Port Elizabeth, South Africa, 6001
Somerset West, South Africa, 7130
Switzerland
Basel, Switzerland, 4055
Bern, Switzerland, 3010
Zurich, Switzerland, 8091
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00503113     History of Changes
Other Study ID Numbers: BA20341
Study First Received: July 17, 2007
Results First Received: March 31, 2011
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014