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Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis - NCT00926380-02114(Clinical Trial 299325)



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City:  Boston
State:  
MA
Zip Code: 02114
Conditions: Osteoporosis
Purpose: The aim of this study is to determine whether denosumab (an investigational medication), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.
Study summary:
Criteria: Inclusion Criteria: Must satisfy A and B and C and D below: - (A) Women aged > 55 - (B) Postmenopausal - (C) Osteoporotic with high risk of fracture Exclusion Criteria: - Confirmed serum alkaline phosphatase above upper normal limit with no explanation - Liver disease (AST or ALT > 2 x upper normal limit). - Renal disease (serum creatinine > 2.0 mg/dl). - Hypercalcemia (Ca >10.5 mg/dL) - Elevated blood PTH (intact PTH > 65 pg/ml) - Serum 25-OH vitamin D < 20 ng/ml - HCT < 32%. - History of malignancy (except basal cell carcinoma) or radiation therapy. - Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures. - Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. - Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. - Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease) - Current use or use in the past 6 months of oral bisphosphonate - Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin. - Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months. - Any current or previous use of strontium or any parenteral bisphosphonate. - Known sensitivity to mammalian cell-derived drug products. - Known sensitivity to teriparatide or any of its excipients.
Study is available at: Massachusetts General Hospital
Boston, MA 02114
United States

Primary Contact:
Elizabeth A McKay, BA
Email: emckay@partners.org
Phone: 617 726 6129
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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