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): 55.0-85.0,  Osteoporosis, Post-Menopausal Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after menopausal) are included at the time of entry into the trial. They have to be free of severe or chronically disabling conditions other than osteoporosis The patient should have a documented (X-ray) prevalent osteoporotic vertebral fracture or non-vertebral fragility fracture (excluding major trauma). Vertebral deformities will be evaluated on lateral views of the thoracic and lumbar spine. T-12 will be visible on both views so that all vertebrae from T-4 to L-4 can be identified. The radiographs will be performed according to a standardized protocol L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures; therefore at least 3 vertebrae should be without fractures, osteophytes, or other abnormalities that would interfere with the analysis of the posterior-anterior lumbar spine BMD measurement. The reading of the BMD, T-score should be in the range of 0 and 0 at least for one of the 2 sites measured (spine or hip). The initial lumbar spine and femoral neck BMD assessment and the determination of the patient's for entry into the screening phase will be made by the central quality assurance for BMD. The central quality assurance center will determine the patient's for enrollment into the treatment phase. If the L-1 vertebra cannot be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis Women without language barriers, cooperative and expected to return for all follow-up procedures and who have given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study Normal or clinically insignificant abnormal laboratory values including serum calcium, PTH (1-84) levels and alkaline phosphatase  History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year prior to Visit 2 History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients with any history of nephro or urolithiasis must have an appropriate radiology study within 6 months prior to Visit 2. This radiology study, such as an intravenous pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the absence of active disease History of other malignant neoplasms in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may enter the study Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; patients who have received radiation therapy involving the skeleton History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or hyperthyroidism