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Efficacy and safety study of intravenous ibandronate to treat postmenopausal osteoporosis as compared to daily oral ibandronate



Efficacy and safety study of intravenous ibandronate to treat postmenopausal osteoporosis as compared to daily oral ibandronate

For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: The purpose of this study is to compare the effectiveness and safety of two doses of intravenous (given through the veins) ibandronate, 2 mg every 2 months or 3 mg every 3 months, with 2.5 mg daily oral ibandronate in the treatment of postmenopausal osteoporosis
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 55 Years/80 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Woman, at least five years after menopause - Age 55-80 years - Patients must be able to walk about at the beginning of the trial and expected to remain so throughout the course of the trial - Osteoporosis of the spine as detected by a DEXA scan which is a special test that measures bone density Exclusion Criteria: - Significant medical disease - Malignant disease diagnosed within the previous 10 years, breast cancer diagnosed within the previous 20 years - Allergy to bisphosphonates (the family of drugs used to treat osteoporosis to which ibandronate belongs) - Inability to take calcium or vitamin D - Impaired kidney or liver function - History of major upper gastrointestinal disease - Previous treatment with an oral bisphonsphonate within the last 6 months or more than one month of treatment with an oral bisphosphonate within the last year - Treatment with fluoride for osteoporosis within the last 12 months - Treatment with parathyroid hormone for osteoporosis within the last 2 years - Treatment with other drugs affecting bone metabolism within the last 6 months - Previous treatment with an intravenous (given through the veins) bisphosphonate at any time
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:  BM16550; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048074

Other Osteoporosis Studies:
1. Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis

2. Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer

3. CVD Risk and Health in Postmenopausal Phytoestrogen Users

4. Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency

5. Calcium and Bone Mass in Young Females

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