Status:
COMPLETED
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Amgen
Conditions:
Osteoporosis
Eligibility:
FEMALE
45+ years
Phase:
PHASE2
Brief Summary
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 dens...
Eligibility Criteria
Inclusion
- Must satisfy A and B and C and D below:
- (A) Women aged \> 55
- (B) Postmenopausal
- (C) Osteoporotic with high risk of fracture
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00926380
Start Date
June 1 2009
End Date
December 1 2016
Last Update
June 29 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114