Male Osteoporosis MedDRA version: 14.0 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: BMD values (g/cm2) assessed by the local site at either the lumbar spine OR femoral neck that occur within the following ranges, based on the particular scanner that is used: GE Lunar Hologic Lumbar spine 0.800 = BMD = 0.980 0.706 = BMD = 0.871 Femoral neck 0.573 = BMD = 0.808 0.454 = BMD = 0.658 OR For subjects with a history of a major osteoporotic fracture (clinical vertebral, hip, humerus and distal radius fractures) occurring more than 6 months prior to screening, BMD values (g/cm2) assessed by the local site, at either the lumbar spine OR femoral neck that occur within the following ranges, based on the particular scanner that is used: GE Lunar Hologic Lumbar spine 0.800 = BMD = 1.100 0.706 = BMD = 0.981 Femoral neck 0.573 = BMD = 0.965 0.454 = BMD = 0.794 At least 2 lumbar vertebrae, at least 1 hip and at least one forearm must be evaluable by DXA. Ambulatory males 30 to 85 years of age inclusive at the start of screening. Provide the appropriate written informed consent before any study-specific procedure. 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 102 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 138
Exclusion criteria
Exclusion criteria: BMD values (g/cm2) in subjects with or without a history of major osteoporotic fractures, based on the particular scanner that is used: GE Lunar Hologic Lumbar spine BMD 2.5 x upper limit of normal. Serum alanine aminotransferase; serum glutamate-pyruvate transaminase > 2.5 x upper limit of normal (both as determined by the central laboratory). Significantly impaired renal function as determined by a derived glomerular filtration rate (using the Modification of Diet in Renal Disease formula) of = 30 mL/min/1.73 m2 calculated by the central laboratory. Hypo- or hypercalcemia based on the central laboratory reference ranges for albumin-adjusted serum calcium. Known to have tested positive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen or cirrhosis of the liver. Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma) within the last 5 years. Any metabolic bone disease, eg osteomalacia, osteogenesis imperfecta, rheumatoid arthritis, Paget’s disease, Cushing’s disease or, hyperprolactinemia which may interfere with the interpretation of the findings OR evidence of malabsorption syndromes which might interfere with absorption of vitamin D. Received any solid organ or bone marrow transplant or is on chronic immunosuppression for any reason. Any laboratory abnormality, which in the opinion of the investigator or Amgen, will prevent the subject from completing the study or interfere with the interpretation of the study results. Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Oral bisphosphonate treatment: • = 3 months cumulatively in the past 2 years, OR • = 1 month in the past year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the effect of denosumab 60 mg Q6 months compared with placebo on lumbar spine BMD at 12 months in men with low BMD.;Secondary Objective: The secondary objectives are to evaluate the effects of denosumab in men with low BMD compared to placebo on • BMD at proximal femur (total hip, hip trochanter, femoral neck) and distal radius at 12 months • CTX at Day 15 ;Primary end point(s): The primary efficacy endpoint is the percent change from baseline in the lumbar spine BMD ;Timepoint(s) of evaluation of this end point: At 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percent change from baseline in BMD of the total hip, femoral neck, hip trocanter and distal radius - Percent change from baseline in CTX ;Timepoint(s) of evaluation of this end point: - Percent change from baseline in BMD of the total hip, femoral neck, hip trocanter and distal radius at Month 12 - Percent change from baseline in CTX at Day 15 | — |
Countries
Belgium, Canada, Denmark, European Union, France, Sweden, United States
Contacts
Public ContactIHQ Medical Info– Clinical trials
Amgen (EUROPE) GmbH
Outcome results
None listed