Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
This trial is active, not recruiting.
|Sponsor||Massachusetts General Hospital|
|Start date||June 2009|
|End date||February 2016|
|Trial size||90 participants|
|Trial identifier||NCT00926380, 20080723, 2009P000525|
The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
time frame: 06/2009-02/2015
Female participants at least 45 years old.
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.
|Official title||The Denosumab And Teriparatide Administration Study (DATA)|
|Principal investigator||Benjamin Z Leder, MD|
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