Postmenopausal osteoporosis
Conditions
Interventions
Subjects will receive a 60mg SC injection of denosumab every 6 months for 24
months (at Day 1, 6 months, 12 months and 18 months)
Sponsors
Amgen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety monitoring, including adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (serum chemistry, hematology) and subject incidence of anti-denosumab antibody formation in subjects previously treated with denosumab who receive up to 5 years of denosumab administration | — |
Secondary
| Measure | Time frame |
|---|---|
| - BMD of the lumbar spine, total hip and in a subset of subjects distal radius at month 12 and month 24 - Vertebral fractures at month 24 and non-vertebral fractures at month 12 and month 24 - Bone Turnover Markers (Type 1 CTX, iPTH, RANKL, OPG, BALP, P1NP) in a subset of subjects at Day 10, month 6, month 12 and month 24 - Serum calcium values at Day 10 - Bone histology in a subset of subjects previously treated with denosumab who receive up to 5 years of denosumab administration - Safety monitoring, including adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (serum chemistry, hematology), and subject incidence of anti denosumab antibody formation in subjects previously treated with placebo who receive up to 2 years of denosumab administration | — |
Countries
Netherlands
Outcome results
None listed