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OpenTrials
Completed

NCT Number: NCT00503113

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

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.

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Key information

Conditions

Post-Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

3mg intravenous (iv) injection every 3 months

Alendronate

Drug

70mg per oral (po) weekly

Primary outcomes

  1. 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

    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 outcomes

  1. Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)

    Time frame: Baseline and 9 months

    Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.

  2. Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)

    Time frame: Baseline and 9 months

    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.

  3. Relative Change From Baseline in Actual GFR (Using CG Formula)

    Time frame: Baseline and 9 months

    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.

  4. Absolute Change From Baseline in Mean Serum Creatinine.

    Time frame: Baseline and 9 months

  5. Relative Change From Baseline in Mean Serum Creatinine.

    Time frame: Baseline and 9 months

  6. Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.

    Time frame: Baseline and 9 months

  7. Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.

    Time frame: Baseline and 9 months

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 18, 2007
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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