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A Multicenter Trial of Low Dose Gallium Nitrate in Patients with Advanced Paget’S Disease of Bone

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A Multicenter Trial of Low Dose Gallium Nitrate in Patients with Advanced Paget’S Disease of Bone Vol. 80. No. 2 Journalof CbnicalEndocrinology and Metabolism Pr’rrnrrd ,,, IJ S.A. CopyrIght0 1995by The EndocrineSociety A Multicenter Trial of Low Dose Gallium Nitrate in Patients with Advanced Paget’s Disease of Bone RICHARD S. BOCKMAN, FRANCOIS WILHELM, ETHEL SIRIS, FREDERICK SINGER, ARTHUR CHAUSMER*, RACHELLE BITTON, JON KOTLER, BARBARA J. BOSCO, DAVID R. EYRE, AND DAVID LEVENSON Department of Medicine, Hospital for Special Surgery and Cornell University Medical College (R.S.B., B.J.B., D.L.), New York, New York 10021; Research and Development, Fujisawa Pharmaceutical Co. (F.W.), Deer-field, Illinois 60015; Columbia University College of Physicians and Surgeons (E.S.), New York, New York 10032; St. John’s Hospital and Health Center, John Wayne Cancer Institute (F.S.1, Santa Monica, California 90404; the Division of Endocrinology, Long Island Jewish Hospital (R.B.1, New Hyde Park, New York 11042; Holy Cross Hospital (J.K.), Ft. Lauderdale, Florida 33008; and the Department of Orthopaedics, University of Washington (D.R.E.), Seattle, Washington 98195 ABSTRACT treated with the 0.5 mg/kg.day dose achieved a 50% or more reduction Gallium nitrate is a potent antiresorptive drug that has been ex- in enzyme activity. The nadir value in hydraxyproline excretion oc- tensively tested in patients with accelerated bone turnover. We have curred at 10 weeks, with mean changes of +9%, -lo%, and ~ 17% for evaluated the effects of this new agent in a pilot multicenter trial of the 0.05, 0.25, and 0.5 mg/kg.day doses, respectively; the difference 49 patients with advanced Paget’s disease of bone. Patients were was significant only at the 0.5 mg/kg.day level (P < 0.01). Urinary randomized to receive 0.05, 0.25, or 0.5 mg/kg.day gallium nitrate collagen cross-link excretion showed a significant decrease at the 0.25 administered by SCinjection in two 14-day cycles. Serum alkaline and 0.5 mg/kg.day doses. We also observed a definite, but nonsignif- phosphatase, fasting 2-h urinary hydroxyproline and N- telopeptide icant, trend for improved quality of life in patients treated at the collagen cross-links excretion, and quality of life were assessed every highest drug dose. Minor discomfort at the injection site was fre- 2 weeks for 12 weeks. The group mean alkaline phosphatase activity quently reported, but did not lead to interruption of therapy. Our at baseline was 854 2 100 (t SEM) IUL The mean changes from results in these patients who had received moderate to extensive prior baseline to week 12 in serum alkaline phosphatase were +0.5%‘, therapies with other drugs show that cyclical, low dose, SCadminis- ~24%, and -31%, respectively, for the three doses tested. The dif- tration of gallium nitrate is safe and effective for treating patients ferences for each of the higher dose levels (0.25 and 0.5 mg/kg.day) with advanced Paget’s disease of bone. (J Clin Endocrinol Metab 80: was statistically significant (P 5 0.05), and nearly half of the patients 595-602, 1995) AGET’S disease of bone is characterized by abnormally osteoclastic activity have proven useful for the treatment of P accelerated bone remodeling that is driven by excessive active Paget’s disease, including antiresorptive agents, such osteoclastic resorption (1, 2). The affected bones are fre- as calcitonin (7, 8, 15-19) and bisphosphonates (10-14, quently deformed and more susceptible to fracture due to 20-36), as well as agents that are cytotoxic for osteoclasts, their abnormal structure and architecture. The extent and such as plicamycin (mithramycin) (37). activity of Paget’s disease correlate with serum alkaline phos- Gallium nitrate is a potent new antiresorptive drug that phatase levels (a measure of osteoblastic activity) as well as has been approved for the treatment of cancer-related hy- urinary excretion of hydroxyproline (an index of bone matrix percalcemia (38). When administered iv at moderate doses resorption) (3,4). Serum alkaline phosphatase is considered (200 mg/m*.day or -5 mg/kg.day), several randomized a reliable biochemical index of disease activity, with a low double blind studies have shown highly significant superi- coefficient of variation within a single patient (5); however, ority of this drug relative to calcitonin (38) and bisphospho- changes in alkaline phosphatase often take weeks to occur nates (39,40). Additional studies have shown that the agent after effective therapy has been initiated (6-13). The coeffi- markedly reduces the biochemical parameters of accelerated cient of variation within patients for hydroxyproline is much bone turnover in patients with cancerous metastases (41) and greater than that for alkaline phosphatase, making hy- increases mineral content in patients with multiple myeloma droxyproline a less sensitive marker with which to assess (42). In vitro studies would suggest that gallium nitrate acts treatment response (5, 14). Although the etiology of this directly on osteoclasts to inhibit bone resorption and that this disorder is unknown, drugs that are capable of suppressing action is not a consequence of a cytotoxic effect on bone cells (43, 44). Received May 20, 1994. Revision received October 7, 1994. Accepted Pilot studies have evaluated both moderate dose iv infu- October 17, 1994. sions (2.5 mg/kg.day) and low dose SCinjections (0.5 and 0.25 Address all correspondence and requests for reprints to: Richard S. mg/kg.day) of gallium nitrate in heavily pretreated and Bockman, M.D., Ph.D., Hospital for Special Surgery, 535 East 70th Street, drug-resistant patients with advanced Paget’s disease New York, New York 10021. * Current address: Veterans Administration Medical Center, 510 East (45, 46). These early studies showed a marked decrease in Stoner, Shreveport, Louisiana 71101. both serum alkaline phosphatase levels and urinary 595 Downloaded from jcem.endojournals.org at Stanford Univ. Medical Center Lane Medical Lib., Route 1 on February 8, 2010 BOCKMAN ET AL. JCE & M . 1995 Vol80 . No 2 hydroxyproline excretion, with suggestive evidence of a was separated, frozen at -70 C, and sent to a central reference labora- dose-response relationship. The potent antiresorptive effects tory. For the urine specimens, the total volumes were measured, and an aliquot was frozen and sent to the reference laboratories. of this drug, its safety, and the favorable biochemical re- sponse to these reduced doses in pilot studies prompted us to conduct the first multicenter randomized trial of this agent Quality of life assessment in patients with advanced Paget’s disease of bone. At baseline, patients underwent a medical history and physical ex- amination. Each patient gave a subjective assessment of “pain experi- enced now,” “pain experienced during the last week,” physical activity, Subjects and Methods and quality of life. The first three parameters were measured by a loo-mm visual analog scale. Quality of life was assessed by completing Study centers a questionnaire regarding interference with seven specific activities (i.e. general activity, mood, walking ability, normal work, relationship to Between September 1, 1991, and April 20, 1992, 49 patients were others, sleep, enjoyment of life, and global quality of life). enrolled in a randomized prospective study at 6 sites. Patients with a known history of Paget’s disease underwent radionuclide bone scanning and radiographs of affected skeletal areas. Entry criteria included a Statistical analyses serum alkaline phosphatase level at least twice the upper limit of normal. In addition, patients could not have taken calcitonin or mithramycin For baseline characteristics, comparisons between treatment groups within the preceding 8 weeks, nor any bisphosphonate within the pre- were performed by analysis of variance (ANOVA) for parametric sta- ceding 6 months. None of the patients was taking other medications that tistics and 2 analyses for categorical data. For alkaline phosphatase and affected skeletal metabolism during the 12-week treatment phase. If a urinary hydroxyproline, the percent change from baseline at each mea- patient had been previously treated with any antiresorptive medication, sured time point was calculated for each patient. Comparisons were their serum alkaline phosphatase level had to have returned to their performed using ANOVA, with week number and treatment dose as the previous baseline value before entry. main variables. Intergroup and weekly comparisons were made using the Student-Newman-Keuls and pairwise t tests (least squared differ- ence) on the means, respectively. Additional analyses were performed, Baseline calibration studies with dose and site as independent variables. Changes in hemoglobin levels were analyzed by calculating the means and percentage of pa- Two-hour fasting urine specimens were collected daily for 5 days in tients with a decrease greater than 1.5 mg/dL. Statistical analyses were a subset of patients (12) from a single study site. This short 5-day interval performed with pairwise t and 2 tests, respectively. was selected to minimize the possible variability of disease activity. Bone pain and quality of life assessments were performed using Patients were instructed to fast after 2000 h and upon waking the next questionnaires developed for patients with rheumatological diseases. morning after a 12-h fast to discard the first voided urine specimen, then These methods of assessing subjective responses to disease state or to drink 24 oz water. Urine was collected over the first 2 h after waking. treatment efficacy have not been validated in patients with Paget’s Urinary volume, creatinine, and hydroxyproline were measured by the disease. Continuous variables (visual analog scales of bone pain and usual clinical laboratory procedures (47). Fasting 2-h samples show a physical activity) were compared using ANOVA, with week number high correlation with 24-h collections taken under strict dietary restric- and treatment dose as the main effects. Between-treatment groups and tions (48). Collagen cross-link determinations were made on the fasting between-week comparisons were made using the Student-Newman- urine samples by measuring N-telopeptides containing pyridinoline Keuls and pairwise t tests on the means, respectively.
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