Male osteoporosis
Conditions
Interventions
Experimental group:Prolia
Sponsors
The Sixth People‘s Hospital of Shanghai
Eligibility
Sex/Gender
Male
Age
30 Years to 90 Years
Inclusion criteria
Inclusion criteria: 101 Subject has provided informed consent before initiation of any study specific activities/procedures. Subject’s legally authorized representative has provided informed consent before any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent. 102 Ambulatory men aged = 30 years and = 90 years old at the time of signing the informed consent. 103 Men at the time of screening will be required to have lumbar spine or total hip BMD T-score = -2.5 or T-score= -1.5 and a history of a fragility fracture. Subjects with T score of = -1.5 must have radiographs report of the previous fracture submitted to the central imaging vendor for confirmation before enrollment. 104 Have to have at least two intact vertebrae at baseline (L1-L4) 105 Adequate organ function, defined as follows: • Hematology parameters: o Absolute neutrophil count = 1 x 10^9/L o Platelet count = 100 x 10^9/L o Hemoglobin > 10 g/dL (100 g/L) • Renal function as follows: o Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m^2 • Hepatic function: o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase < 3 X upper limit of normal (ULN) o Total bilirubin < 1.5 X ULN
Exclusion criteria
Exclusion criteria: Disease Related 201 Any condition that could affect bone metabolism such as Paget’s disease of bone, osteomalacia including secondary causes of osteoporosis (subjects with low testosterone levels are allowed). Other Medical Conditions 202 Hyper- or hypothyroidism; however, stable subjects, in the investigator’s opinion,on thyroid hormone replacement therapy are allowed. 203 Hyper- or hypoparathyroidism. Intact parathyroid hormone values outside of the reference range as determined by the central laboratory. 204 Subjects with a history of any cancer (cured basal cell or squamous cell cancers are allowed). 205 Any condition that in the opinion of the investigator would not allow the subject to complete 1 year study and comply with the requirement of the study protocol. Prior/Concomitant Therapy 206 Hypogonadism requiring testosterone replacement therapy unless on a stable dose for at least 12 months. 207 Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Systemic glucocorticoids: = 7.5 mg prednisone equivalent per day for more than 14 days within 3 months before randomization. Any bone anabolic treatment within 1 year. Anabolic steroids or testosterone: any use within 6 months before randomization 208 Oral bisphosphonates treatment: = 3 months cumulatively in the past 2 years, OR = 1 month in the past year, OR Any use during the 3-month period before randomization 209 Known to have tested positive for human immunodeficiency virus, hepatitis Cvirus, hepatitis B surface antigen, or cirrhosis of the liver. 210 Received any solid organ or bone marrow transplant or is on chronic immunosuppression for any reason. 211 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. 212 Oral/dental conditions that would require an intervention including tooth extraction during the course of the study Prior/Concurrent Clinical Study Experience 213 Currently receiving treatment in another investigational device or drug study, or less than 1 month since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. Diagnostic Assessments 214 Vitamin D levels 10.5 mg/dl Other Exclusions 216 Subject has known sensitivity to any of the products or components to be administered during dosing. 217 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge. 218 History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMD; | — |
Secondary
| Measure | Time frame |
|---|---|
| bone turnover marker;safety; | — |
Countries
China
Contacts
Public ContactZhenlin Zhang
The Sixth People‘s Hospital of Shanghai
Outcome results
None listed