Paget's disease of bone is a chronic skeletal disease that affects elderly people and is characterized by areas of increased skeletal remodeling which can lead to pain, deformity, secondary arthritis, fractures and rarely malignant degeneration. Several studies suggest that Paget's disease affects 1.8-5% of people over 60 years of age and 10% of people at 90 years of age. In work described in this proposal, patients with Paget's disease involving the femur, tibia, and/or acetabular portion of the ilium, are shown to have substantial impairments of mobility, functional status, and psychosocial performance and manifest increased amounts of pain. We have treated six of these older patients with pamidronate, a second generation bisphosphonate, and shown improvement in mobility and functional status impairments as well as bone remodeling activity. In order to determine if pamidronate will improve mobility impairments, functional status, pain, and psychosocial performance, we propose to use a randomized, double-blind, placebo-controlled trial in which 66 patients with active Paget's disease of femur, tibia, and/or acetabular portion of the ilium will be treated (pamidronate or placebo) and then followed for 6 months. All patients who enter the trial must have documented impairments in mobility, defined as an abnormal mobility measure (ten foot walk time, 360 degree turn, mobility skills protocol score, or 6 minute walk distance) and bone resorption or formation markers that are at least twice the normal level. When patients who have Paget's disease enter the study, they will have baseline measures performed and then be randomized to receive pamidronate 90 mg intravenously over six hours or placebo. Measurements will be made at one, three and six months post therapy.
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