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

This study is ongoing, but not recruiting participants.

First Received: July 17, 2007 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00503113

Purpose

This 3 arm study will evaluate renal safety after administration of an intravenous 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 i.v. by a) injection or b)infusion once every 3 months, or alendronate 70mg p.o. 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 IV

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Ibandronic acid Alendronate sodium Fosamax Ibandronate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change from baseline in actual GFR [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Relative and absolute change in mean actual GFR, serum creatinine and urine albumin-creatinine ratio [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	855
Study Start Date:	July 2007
Estimated Study Completion Date:	April 2010

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 3mg iv injection every 3 months
2: Experimental	Drug: ibandronate [Bonviva/Boniva] 3mg iv infusion every 3 months
3: Active Comparator	Drug: Alendronate 70mg 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

Show 44 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA20341
Study First Received:	July 17, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00503113 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ibandronic acid
Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Kidney Diseases
Bone Diseases
Menopause

Additional relevant MeSH terms:

Ibandronic acid
Musculoskeletal Diseases
Alendronate
Physiological Effects of Drugs
Osteoporosis, Postmenopausal

Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009