Patient description: The patient is a 60 year old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is worsening. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions are detected in the head and face. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. His serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). His family history is only significant for hypertension in his mother and DM type 2 in his father. The diagnosis of Paget's Disease of Bone was confirmed and Bisphosphonate will be started as first-line therapy.

Clinical trial eligibility criteria: eligible ages (years): 18.0-50.0,  Healthy Caucasian males healthy individuals based on history/physical examination and laboratory evaluations (no out-of-range results from hematology tests (hemoglobin (Hb) > 130 g/L in men; absolute neutrophil count (ANC) > 2000 cells/uL; platelets > 159 x 109/L), biochemistry (AST < 35 IU/L, ALT < 40, IU/L, alkaline phosphatase < 100 IU/L, total bilirubin < 17 umol/L, lipase < 45 IU/L, creatinine < 120 umol/L, normal coagulation tests (INR < 1.2, aPPT < 40 seconds) and urinalysis LDL-cholesterol </= 5 mmol/L, triglycerides </= 1.7 mmol/L and a 10 year estimate of cardiovascular (CV) disease risk of </= 10% ("low risk") as per the Framingham risk score modified for family history (doubling of CV risk if any CV disease in a first-degree relative before 60 years of age); the modified Framingham risk score takes into account age, HDL-cholesterol, total cholesterol, systolic blood pressure, smoker status, presence of diabetes and family history of CV disease normal 12-lead electrocardiogram systolic blood pressure between 105 and 130 mmHg diastolic blood pressure between 60 and 90 mmHg supine heart rate between 60 and 100 beats per minutes no evidence of HIV infection (ELISA test and Western Blot), no evidence of hepatitis B virus infection (HBsAg negative and anti-HBcAg negative or HBsAg negative with positive anti-HBsAg and positive anti-HBcAg) or HCV infection at screening (anti-HCV serology) using an effective barrier method of contraception non-smoker  history of postural hypotension cardiac disease acute or chronic liver disease or any hepatic impairment acute or chronic kidney disease or any renal impairment use of prescription drugs, over the counter drugs, recreational drugs, herbal or dietary supplements including vitamins and grapefruit juice within 15 days of study initiation (day 1) except for acetaminophen and/or ibuprofen on an as needed basis. These products will also be prohibited during the study (except for as needed acetaminophen and/or ibuprofen) subjects who received any experimental medication within the last 2 months and/or donated blood during the previous 2 months or intends to donate blood within 2 months following completion of the study will also be excluded subjects who had unprotected sexual activities during the last 6 months with a new or recent partner subjects who injected intravenous drugs over the last 6 months subjects with a social condition, psychological or addictive disorder that would impair protocol adherence