Status:
COMPLETED
A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
Lead Sponsor:
Amgen
Conditions:
Low Bone Mass
Low Bone Mineral Density
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Particip...
Eligibility Criteria
Inclusion
- Ambulatory, postmenopausal women
- Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, attended an end of study visit)
- At least 12 months have elapsed since their end of 20050179 study visit
- Provide signed informed consent
Exclusion
- Subjects who failed to receive both doses of denosumab (or SQ \[subcutaneous\] placebo) during the 20050179 study
- Subjects who were randomized to the alendronate arm during the 20050179 study
- Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
- Hyperthyroidism
- Hyperparathyroidism
- Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
- Other diseases which affect bone metabolism
- Self-reported alcohol or drug abuse within the previous 12 months
- Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
- Received any investigational product other than denosumab in two years before the screening visit.
- Received \> 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
- Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
- Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00890981
Start Date
July 1 2009
End Date
August 1 2010
Last Update
April 2 2014
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