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||December 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.
- (A) Women aged > 55
- (B) Postmenopausal
- (C) Osteoporotic with high risk of fracture
- 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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