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A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates - NCT00936897-(Clinical Trial 301363)



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City:  Madison
State:  
WI
Zip Code:
Conditions: Postmenopausal Osteoporosis
Purpose: This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.
Study summary:
Criteria: Inclusion Criteria: - Ambulatory, postmenopausal women (based on medical history) 55 years or older at screening - Postmenopause will be defined as no vaginal bleeding or spotting for at least 12 months - If the subject is 55 - 59 years old and there is uncertainty regarding menopausal status, confirmation of serum FSH (>= 50 mIU/mL) and serum estradiol (<= 20 pg/mL) must be obtained - If the subject is 60 years or older, evaluation of FSH and estradiol levels is not needed to confirm menopausal status - Have received their first prescription of daily or weekly bisphosphonate therapy at least 1 month prior to screening - May have received - raloxifene, calcitonin, prior to initiation of daily orweekly bisphosphonate therapy. - up to 3 doses of monthly bisphosphonate prior to initiation of daily or weekly bisphosphonate therapy - calcium, and vitamin D - Hormone replacement therapy (e.g. estrogen use for mitigation of menopausal symptoms) - Subject has: - Stopped daily or weekly bisphosphonate therapy (is denoted as non-persistent) at least one month before the screening visit, or - Demonstrated low adherence to therapy assessed by a score of less than 6 on the OS-MMAS - Screening BMD (g/cm2) values, at the lumbar spine OR total hip, that occur within the following ranges, based on the particular scanner that is used: GE Lunar Lumbar spine 0.700 < or = BMD < and = 0.940 Total hip 0.504 < or = BMD < or = 0.756 Hologic Lumbar spine 0.607 < or = BMD < or = 0.827 Total hip 0.454 < or = BMD < or = 0.698 Both the initial and the repeat DXA scan of the lumbar spine OR the total hip must meet the above eligibility criteria. - At least 2 lumbar vertebrae must be evaluable by DXA. - At least one hip must be evaluable by DXA (eg, no history of either bilateral hip replacement or pins in both hips) - Provide signed informed consent before any study-specific procedures are conducted Exclusion Criteria: - Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures - Current or prior use of medications prescribed for osteoporosis treatment other than oral daily or weekly bisphosphonate - Contraindicated to receive oral ibandronate 150mg PO QM, including - Hypersensitivity to ibandronate 150mg PO QM or other constituents of ibandronate 150mg PO QM tablets - Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes - Administration of any of the following treatments within 3 months of screening - Tibolone - Anabolic steroids or testosterone - Glucocorticosteroids (>= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of >= 50 mg) - Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)] - Repletion will be allowed and subjects may be re-screened - Evidence of any of the following per subject report, chart review or central laboratory result: - Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less that 30mL/min/1.73 m2 determined by the central laboratory - Current hypo- or hypercalcemia based on the central laboratory reference ranges - Active gastric or duodenal ulcer; or any history of significant gastrointestinal bleed requiring hospitalization or transfusion - Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen - Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years - Any metabolic bone disease or secondary cause of bone loss that is not controlled and may interfere with the interpretation of the findings - Previous participation in clinical trials with denosumab 60mg SC Q6M (regardless of treatment) - Received any solid organ or bone marrow transplant - Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results - Known sensitivity to mammalian cell derived drug products - Known intolerance to calcium supplements - Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) - Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results - Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the study
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Data Source: ClinicalTrials.gov
Date Processed: November 11, 2010
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