An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
- Conditions
- Postmenopausal osteoporosis10005959
- Registration Number
- NL-OMON30869
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 62
- Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60mg SC injection every 6 months.
- Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit
- Permanently non-ambulatory subjects (use of an assistive device e.g. cane, walker etc is permitted)
- Missed two or more investigational product doses during the 20030216 study
- 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
- Developed sensitivity to mammalian cell derived drug products during the 20030216 study
- Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)
- Receiving any investigational product other than denosumab
- Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
- For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety monitoring, including adverse event incidence, serious adverse event<br /><br>incidence, changes in safety laboratory analytes (serum chemistry, hematology)<br /><br>and subject incidence of anti-denosumab antibody formation in subjects<br /><br>previously treated with denosumab who receive up to 5 years of denosumab<br /><br>administration</p><br>
- Secondary Outcome Measures
Name Time Method <p>- BMD of the lumbar spine, total hip and in a subset of subjects distal radius<br /><br>at month 12 and month 24<br /><br>- Vertebral fractures at month 24 and non-vertebral fractures at month 12 and<br /><br>month 24<br /><br>- Bone Turnover Markers (Type 1 CTX, iPTH, RANKL, OPG, BALP, P1NP) in a subset<br /><br>of subjects at Day 10, month 6, month 12 and month 24<br /><br>- Serum calcium values at Day 10<br /><br>- Bone histology in a subset of subjects previously treated with denosumab who<br /><br>receive up to 5 years of denosumab administration<br /><br>- Safety monitoring, including adverse event incidence, serious adverse event<br /><br>incidence, changes in safety laboratory analytes (serum chemistry, hematology),<br /><br>and subject incidence of anti denosumab antibody formation in subjects<br /><br>previously treated with placebo who receive up to 2 years of denosumab<br /><br>administration</p><br>