Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Completed · Phase 2
Conditions studied: Osteoporosis
In brief
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.
Key facts
- Study ID
- NCT00926380
- Run by
- Massachusetts General Hospital
- People needed
- 94
- Starts
- 2009-06-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-06-29
Who can join
Age: 45 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Must satisfy A and B and C and D below:
- (A) Women aged > 55
- (B) Postmenopausal
- (C) Osteoporotic with high risk of fracture
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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