Treatment of postmenopausal osteoporosis MedDRA version: 17.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Prolia
Product Name: Denosumab
Product Code: AMG 162
Pharmaceutical Form: Solution for injection
CAS Number: 615258-40-7
Current Sponsor code: AMG 162
Other descriptive name: Immunoglobuli
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
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. Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 107 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4443
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) - Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study - 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 |
|---|---|
| Main Objective: To describe the safety and tolerability of up to 10 years or 7 years of denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab or placebo, respectively. ;Secondary Objective: To describe the -effect of denosumab administration on changes in lumbar spine, total hip and distal radius Bone Mineral Density (BMD) in subjects who previously received denosumab and in subjects who previously received placebo. -incidence of vertebral and non vertebral fractures following denosumab administration in subjects who previously received denosumab and in subjects who previously received placebo. -effect of denosumab administration on markers of bone turnover in subjects who previously received denosumab and in subjects who previously received placebo. -change in serum calcium values between the Baseline and Day 10 visit in subjects who previously received denosumab and in subjects who previously received placebo. -effect of up to 10 yrs denosumab administration on bone histology in subjects who previously received denosumab .;Primary end point(s): The primary endpoint is 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.;Timepoint(s) of evaluation of this end point: Up to 84 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Actual values, changes and percent changes in BMD of the lumbar spine, total hip and distal radius from baseline • Actual values, changes and percent changes in BMD of the lumbar spine, total hip and distal radius from study 20030216 baseline • Subject incidence of vertebral fractures • Subject incidence of non-vertebral fractures during the study markers from baseline • Actual values, changes and percent changes in bone turnover markers from study 20030216 baseline • Actual value, change and percent change from baseline in albumin-adjusted serum calcium • Serum denosumab concentrations • Actual values of bone biopsy measurements ;Timepoint(s) of evaluation of this end point: • Values and changes in BMD of the at all timepoints • Values and changes in BMD of the from study 20030216 baseline at all timepoints • Subject incidence of vertebral fractures at months 24, 36, 60, and 84 • Subject incidence of non-vertebral fractures during the study markers from baseline at all timepoints • Values and changes in bone turnover markers from study 20030216 baseline at all timepoints • Values and changes from baseline in albumin-adjusted serum calcium at Day 10 • Serum denosumab concentrations at all timepoints • Values of bone biopsy measurements at months 24 and 84 | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Mexico, Serbia, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info– Clinical trials
Amgen (EUROPE) GmbH
Outcome results
None listed