Safety Of Pamidronate Research Articles

Comparing the Efficacy of Pamidronate and Thalidomide for the Treatment of Refractory Axial Spondyloarthritis: An Open Label Randomized Clinical Trial

Introduction: Spondyloarthritis (SpA) is a chronic systemic inflammatory rheumatic disease affecting sacroiliac joints, spine and peripheral joints. Pamidronate and thalidomide are proven to be effective in refractory axial SpA in some studies. This study aimed at comparing the efficacy and safety of pamidronate and thalidomide in refractory axial spondyloarthritis (SpA). Methods: This open label randomized clinical trial was conducted on refractory SpA patients at the department of rheumatology of Bangabandhu Sheikh Mujib Medical University, Dhaka. Pamidronate 60mg intravenous monthly and thalidomide 200mg/day were given to pamidronate and thalidomide groups, respectively for 6 months. Both groups received non-steroidal anti-inflammatory drugs and therapeutic exercises. More than 20% improvements in Assessment of Spondyloarthritis International Society (ASAS-20) at 6 months were considered as primary outcome measure. Secondary outcome measures included Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), Bath ankylosing spondylitis meteorological index (BASMI), patient global assessment, physician global assessment, erythrocyte sedimentation rate (ESR), C-reactive protein, ASAS 40 etc. Results: Significant improvement in ASAS 20 was observed in both pamidronate (76.9%) and thalidomide (85.2%) groups (P=0.501). Among the secondary outcome ASAS 40 response rates were 46.2% and 51.9% in the pamidronate and thalidomide groups respectively. All other secondary outcome indicators such as BASDAI, BASFI, BASMI etc. within-group showed significant improvements in both groups (P<0.001). Between-group differences were nonsignificant (P>0.1) except for ESR (P=0.006). There were no serious adverse events in any group. Conclusions: Pamidronate and thalidomide were effective in refractory axial SpA and were well tolerated. However, there was no significant difference in the efficacy of the two drugs. J Bangladesh Coll Phys Surg 2023; 41(4): 269-276

Patient-reported effectiveness and safety of Pamidronate in NSAIDs-refractory chronic recurrent multifocal osteomyelitis in children

To evaluate patient-reported effectiveness, safety and social influence of Pamidronate in the therapy of NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis in children. Authors reviewed self-created questionnaires, which asked patients for symptoms alleviation, adverse drug reactions frequency and degree of severity and daily activities self-reliance. Only surveys with complete answers, which were returned to authors by an e-mail from juvenile patients treated for NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis at the University Children’s Hospital of Cracow were analyzed. Between 2010 and 2019, 61 children were diagnosed with NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis at our department. Out of 61 requests sent, 42 complete replies (33 females, 9 males) were gathered and analyzed. All patients included in this research were administered with at least one set of Pamidronate intravenously in the dose of 1 mg/kg/day for 3 consecutive days. Our analysis shows remarkable in terms of patient’s impressions decrease of pain intensity after 2.5 series of Pamidronate on average, and total pain resolution after 5.9 series on average. Overall number of adverse drug reaction events reported by responders was 105. One patient developed drug-dependent renal insufficiency in the course of therapy. Outcome assessment indicates that nearly 50% of the studied population was more eager to participate in social life just after the first infusion of the drug. 95% of the surveyed unanimously agreed to recommend Pamidronate therapy to cure NSAIDs-refractory CRMO. 39 out of 42 (93%) patients considered Pamidronate effective at the end of the treatment. Onset of Pamidronate’s action is gradual and differs in terms of symptoms alleviation between sexes. The therapy can induce considerable number of adverse drug reactions (2.5 per patient). Only 3 out of 42 (7%) patients were free from any ADRs. To demonstrate the impact of the use of Pamidronate on daily activities more precisely, further research with quantification of the quality of life is warranted.

Efficacy and safety of pamidronate in the treatment of parathyroid hormone-dependent hypercalcemia in hospitalized patients

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Efficacy and safety of pamidronate in children with vitamin D intoxication.

Bisphosphonates are used in the treatment of vitamin D intoxication (VDI) after failure of conventional therapy including prednisolone. Safety concerns restrict the use of bisphosphonates from being used as first-line therapy for VDI in children. The aim of this study was to evaluate the efficacy and safety of pamidronate in comparison with prednisolone in children with VDI. We reviewed the hospital records of children consecutively diagnosed with VDI at two medical centers in a 15 year period. The subjects consisted of 21 children (age, 0.3-4.2 years) who were treated with prednisolone and/or bisphosphonates. Pamidronate (n = 18) or alendronate (n = 3) was used in six patients after unsuccessful prednisolone treatment, and in 15 patients from baseline. Initial serum calcium and 25-hydroxyvitamin D were 16.1 ± 1.9 mg/dL and 493 ± 219 ng/mL, respectively. The median time to reach normocalcemia in the pamidronate, alendronate and prednisolone groups was 3 days (range, 2-12 days), 4 days (range, 3-6 days) and 17 days (range, 12-26 days), respectively (P = 0.013). The pamidronate group had a fivefold shorter hospital stay than the prednisolone group. Three patients initially treated with prednisolone developed nephrocalcinosis but this did not occur in any patient treated with bisphosphonates from baseline. Apart from transient fever and moderate hypophosphatemia, no side-effect of bisphosphonate treatment was observed. Pamidronate is efficient and safe for the treatment of VDI in children. Pamidronate use significantly shortens the duration of treatment, and thereby may prevent the development of nephrocalcinosis. Instead of prednisolone, pamidronate should be used together with hydration and furosemide as the first-line therapy for VDI.

Comparison of different treatment approaches in chronic non-bacterial osteomyelitis.

Chronic non-bacterial osteomyelitis (CNO) is a heterogenous group of immune-mediated inflammatory bone diseases, which often co-exist with other rheumatic diseases. There are no approved treatments for CNO, except non-steroid anti-inflammatory drugs (NSAID). The efficacy of methotrexate (MTX), sulfasalazine, pamidronate (PAM), anti-IL1 and TNFα-inhibitors was shown in different reports, but there are some concerns about safety of pamidronate due to long-term accumulation and persistation in bone. The aim of our study was to compare the efficacy of non-randomized different treatment approaches in pediatric patient cohort with CNO.

Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial

BackgroundErosive degenerative disc disease, also known as Modic type 1 changes, is usually characterized by low back pain with an inflammatory pain pattern, as seen in spondyloarthropathies. Intravenous pamidronate has proven to be effective in patients with ankylosing spondylitis who are refractory to nonsteroidal antiinflammatory drugs, and in painful bone diseases in general, such as Paget’s disease, fibrous dysplasia or vertebral fractures. We therefore hypothesize that pamidronate would be effective in treating low back pain associated with Modic type 1 changes.Methods/DesignThis study, called PEPTIDE (short for the French title “Etude Prospective sur l’Efficacité et la tolérance du PamidronaTe dans les dIscopathies Degeneratives Erosives”), will be a double-blind, randomized, placebo-controlled, parallel group, phase two clinical trial. A total of 48 patients will be recruited. These patients will be randomly assigned to one of the two groups, with 24 patients in each group: one group will be given pamidronate and the other a placebo. Pamidronate will be administered at a dose of 90 mg per day for two days consecutively, and every patient, irrespective of treatment group, will be given paracetamol to maintain blinding by preventing drug-induced fever. The primary outcome measure is a between-group difference of 30 points on a 100 mm Visual Analogue Scale (VAS) at three months. Secondary outcome measures are improvement in functional status and the drug’s safety. Primary and secondary outcome measures will be assessed at each visit (inclusion, at six weeks, three months, and six months). If the primary goal is not attained, the patient will be offered a rigid or semi-rigid back brace, irrespective of the treatment group.DiscussionTo date, only local treatments, for example intradiscal corticosteroid therapy, lumbar arthrodesis or back braces have been studied in randomized, controlled trials, with controversial results. This trial is currently ongoing and, if conclusive, should provide physicians with an acceptable alternative to those treatments. The results should be publicly available in spring 2015.Trial registrationClinicalTrials.gov number, NCT01799616.

Cyclic Pamidronate Therapy in Children with Osteogenesis Imperfecta

Severe osteogenesis imperfecta (OI) is a disorder characterized by osteopenia, frequent fractures, progressive deformity, loss of mobility, and chronic bone pain. There has been no effective therapy for the disorder until recently. The main objective of this study was to determine the efficacy and safety of pamidronate in improving bone mineralization and reducing fracture incidence in osteogenesis imperfecta. Intravenous pamidronate was administered to 64 children (from 21 months to 10 years old) with severe OI, in a 1 mg/kg single daily dose for 3 sequential days at 4-month intervals, over 24-48 months duration. Clinical status, biochemical characteristics including bone turnover markers, bone mineral density of the lumbar spine and femoral neck, and radiological changes were assessed regularly during treatment. The number of fractures decreased from a median of 8 (range 4-11) to 0 fractures/year (range 0-4) (p <0.05). After 16 months of treatment, there was significant improvement in bone mineral density (BMD-DEXA) z-score of the lumbar spine from a median of -5.90 (range -7.01 to -4.76) to -2.70 (range -4.46 to -1.98) (p <0.001). Serum alkaline phosphatase (ALP) (bone formation marker) decreased from a median of 731.0 U/l (range 438-998 U/l) to 183 U/l (range 95-286 U/l) (p <0.001), implying a significant reduction in bone turnover and resorption and increase in bone mineralization. There was no improvement in growth velocity or height SDS. Mobility and ambulation improved in all but five children (all five had taken the drug for less than 2.5 years). There was a significant relief of chronic pain and fatigue but no adverse effects in all children using the drug. Cyclic pamidronate administration is effective in improving bone mineralization and reducing fracture incidence in childhood osteogenesis imperfecta.

Uses and Effectiveness of Pamidronate Disodium for Treatment of Dogs and Cats with Hypercalcemia

Uncorrected hypercalcemia can cause clinical signs such as polyuria, polydipsia, vomiting, diarrhea, lethargy, and depression and contributes to the development of primary renal failure and soft tissue mineralization. Treatment of hypercalcemia includes diagnosis and treatment of the underlying disease process and some combination of extracellular fluid volume expansion by administration of fluids intravenously and administration of glucocorticosteroids, salmon calcitonin, and furosemide. Bisphosphonates such as pamidronate disodium also may be safe and effective in the treatment of hypercalcemia. The purpose of our study was to characterize the efficacy and safety of pamidronate in the treatment of hypercalcemia attributable to several different disease processes in the dog and cat. Seven dogs and 2 cats were administered pamidronate at a dose of 1.05‐2.0 mg/kg IV for a variety of disease processes, including neoplasia (n = 4), calcipotriene toxicity (n = 3), nocardiosis (n = 1), and idiopathic hypercalcemia with chronic renal failure (n = 1). In all the animals, IV pamidronate administration rapidly decreased serum calcium concentrations without evident toxicosis. Two animals received pamidronate several times without obvious toxicosis. On the basis of the findings in our retrospective study, pamidronate may be a safe and effective drug with which to lower both serum total and ionized calcium concentrations in patients with hypercalcemia arising from a wide variety of underlying disease processes.

Uses and Effectiveness of Pamidronate Disodium for Treatment of Dogs and Cats with Hypercalcemia

Uncorrected hypercalcemia can cause clinical signs such as polyuria, polydipsia, vomiting, diarrhea, lethargy, and depression and contributes to the development of primary renal failure and soft tissue mineralization. Treatment of hypercalcemia includes diagnosis and treatment of the underlying disease process and some combination of excracellular fluid volume expansion by administration of fluids intravenously and administration of glococorticosteroids, salmon calcitonin, and furosemide. Bisphosphonates such as pamidronate disodium also may be safe and effective in the treatment of hypercalcemia. The purpose of our study was to characterize the efficacy and safety of pamidronate in the treatment of hypercalcemia attritutable to several different disease processes in the dog and cat. Seven dogs and 2 cats were administered pamidronate at a dose of 1.05-2.0 mg/kg IV for a variety of disease processes, including neoplasia (n = 4), calcipotriene toxicity (n = 3), nocardiosis (n = 1), and idiopathic hypercalcemia with chronic renal failure (n = 1). In all the animals, IV pamidronate administration rapidly decreased serum calcium concentrations without evident toxicosis. Two animals received pamidronate several times without obvious toxicosis. On the basis of the findings in our retrospective study, pamidronate may be a safe and effective drug with which to lower both serum total and ionized calcium concentrations in patients with hypercalcemia arising from a wide variety of underlying disease processes.

Usefulness of pamidronate in severe secondary hyperparathyroidism in patients undergoing hemodialysis

Although bisphosphonates have been widely used to treat bone diseases characterized by increased bone resorption, there are limited data showing their possible usefulness in patients on hemodialysis (HD) with secondary hyperparathyroidism. The aim of this study was to evaluate the efficacy and safety of pamidronate in HD patients affected by severe secondary hyperparathyroidism and moderate hypercalcemia who were receiving intravenous calcitriol (Calcijex). In this prospective one-year, open-labeled study, 13 patients (9 women/4 men) with a mean age of 64 +/- 9 years and a mean time on dialysis of 94 +/- 61 months were evaluated. The inclusion criteria were: iPTH>500 pg/mL, Ca>11 mg/dL, P <6 mg/dL, and osteopenia (T-score <-1 SD). Blood levels of Ca, P, alkaline phosphatase (AP), and iPTH were assessed at the beginning of the study and every month. Radiographs of the vertebral spine and bone mineral density (BMD) (lumbar spine and femoral neck) were assessed basal and every 6 months. All patients received 60 mg of pamidronate intravenously every two months throughout the study period. Calcitriol and phosphate binders were adjusted according to iPTH, Ca, and P blood levels. BMD increased in both the lumbar and femoral neck scans (mean increase of 33%) at 6 and 12 months. iPTH increased at 3 months in all patients, and decreased more than 50% in 10 patients after increasing the calcitriol doses. Three patients had no response. A slight decrease in Ca and P was observed in all patients with no significant changes in AP. There were no adverse events. Pamidronate is effective in controlling hypercalcemia in patients on HD with secondary hyperparathyroidism and allows for a more aggressive use of intravenous calcitriol.

Long-term safety of pamidronate: overview from clinical trials

Long-term safety of pamidronate: overview from clinical trials