Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
30–85
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Bone Mineral Density (BMD) values (g/cm2) assessed by the local site at either the lumbar spine OR femoral neck that occur within the ranges specified in the protocol 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 ranges specified in the protocol.
At least 2 lumbar vertebrae, at least 1 hip and at least one forearm must be evaluable by Dual X ray Absorptiometry (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.
You may not be if
BMD values (g/cm2) as specified in the protocol in subjects with or without a history of major osteoporotic fractures, based on the particular scanner that is used.
Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Any severe or more than 1 moderate vertebral fractures on screening spinal x ray
Any vertebral fracture diagnosed within the 6 months prior to screening
Any clinical fracture within the last 6 months prior to screening
For males with a partner of childbearing potential: Subject refuses to use 2 highly effective methods of contraception for the duration of the study and for 10 months after the last dose of study medication.
For males with a partner who is pregnant: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
Previous participation in clinical trials with denosumab or administration of commercial denosumab.
Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
Vitamin D deficiency \[25(OH) vitamin D level \< 20 ng/mL (\< 49.9 nmol/L)\]. Vitamin D replenishment will be permitted and subjects may be re-screened; see Section 7.
Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed.
Hyper- or hypoparathyroidism. Intact parathyroid hormone (iPTH) values outside of the reference range as determined by the central laboratory
Elevated transaminases. Serum aspartate aminotransferase; serum glutamate-oxaloacetic transaminase \> 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 less than or equal to 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:
greater than or equal to 3 months cumulatively in the past 2 years, OR
greater than or equal to 1 month in the past year, OR
Any use during the 3-month period prior to randomization
Administration of any of the following treatments 3 months prior to screening:
Anabolic steroids or testosterone
Glucocorticosteroids (greater than or equal to 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of greater than or equal to 50 mg)
Calcitonin
Calcitriol or vitamin D derivatives \[vitamin D contained in supplements or multivitamins is allowed\]
Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin
Known sensitivity to mammalian cell derived drug products.
Known intolerance to calcium or vitamin D supplements.
Height, weight or girth which may preclude accurate DXA measurements.
Bilateral hip replacements
Any physical or psychiatric disorder 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.
Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding of or completion of the study.
