Papers by Sergio Ortolani
New England Journal of Medicine, 2002
Background Bisphosphonates are effective agents for the management of osteoporosis. Their low bio... more Background Bisphosphonates are effective agents for the management of osteoporosis. Their low bioavailability and low potency necessitate frequent administration on an empty stomach, which may reduce compliance. Gastrointestinal intolerance limits maximal dosing. Although intermittent intravenous treatments have been used, the optimal doses and dosing interval have not been systematically explored. Methods We studied the effects of five regimens of zoledronic acid, the most potent bisphosphonate, on bone turnover and density in 351 postmenopausal women with low bone mineral density in a one-year, randomized, double-blind, placebo-controlled trial. Women received placebo or intravenous zoledronic acid in doses of 0.25 mg, 0.5 mg, or 1 mg at threemonth intervals. In addition, one group received a total annual dose of 4 mg as a single dose, and another received two doses of 2 mg each, six months apart. Lumbar-spine bone mineral density was the primary end point. Results There were similar increases in bone mineral density in all the zoledronic acid groups to values for the spine that were 4.3 to 5.1 percent higher than those in the placebo group (P<0.001) and values for the femoral neck that were 3.1 to 3.5 percent higher than those in the placebo group (P<0.001). Biochemical markers of bone resorption were significantly suppressed throughout the study in all zoledronic acid groups. Myalgia and pyrexia occurred more commonly in the zoledronic acid groups, but treatment-related dropout rates were similar to that in the placebo group. Conclusions Zoledronic acid infusions given at intervals of up to one year produce effects on bone turnover and bone density as great as those achieved with daily oral dosing with bisphosphonates with proven efficacy against fractures, suggesting that an annual infusion of zoledronic acid might be an effective treatment for postmenopausal osteoporosis.
Archives of Osteoporosis, 2010
Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE... more Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU®) is an ongoing longitudinal cohort study that utilises physician-and patient-reported measures to describe the characteristics and management of postmenopausal women on bone loss therapies. We report the study design and Methods Between 2005 and 2008, general practitioners enrolled postmenopausal women initiating, switching or continuing treatment with bone loss treatment in France, Germany, Italy, Spain and the UK. Patients and physicians completed questionnaires at study entry and at 3-month intervals, for 1 year. Results Of 3,402 women enrolled (mean age 68.2 years [SD] 9.83), 96% were diagnosed with low bone mass; 55% of these using dual energy X-ray absorptiometry. Most women (92%) had comorbidities. Mean minimum T score (hip or spine) at diagnosis was −2.7 (SD 0.89; median −2.7 [interquartile range, −3.2, −2.2]) indicating low bone mineral density. Almost 40% of the women had prior fractures in adulthood, mostly non-vertebral, non-hip in nature, 30% of whom had at least two fractures and more than half experienced moderate/severe pain or fatigue. Bisphosphonates were the most common type of bone loss treatment prescribed in the 12 months preceding the study. Conclusions POSSIBLE EU® characterises postmenopausal women with low bone mass, exhibiting a high rate of prevalent fracture, substantial bone fragility and overall comorbidity burden. Clinical strategies for managing osteoporosis in this population varied across the five participating European countries, reflecting their different guidelines, regulations and standards of care.
Arthritis research, 2002
Osteoporosis (OP) and osteoarthritis (OA), the two most common age-related chronic disorders of a... more Osteoporosis (OP) and osteoarthritis (OA), the two most common age-related chronic disorders of articular joints and skeleton, represent a major public health problem in most developed countries. They are influenced by environmental factors and exhibit a strong genetic component. Large population studies clearly show their inverse relationship; therefore, an accurate analysis of the genetic bases of one of these two diseases may provide data of interest for the other disorder. The discovery of risk and protective genes for OP and OA promises to revolutionize strategies for diagnosing and treating these disorders. The primary goal of this symposium was to bring together scientists and clinicians working on OP and OA in order to identify the most promising and collaborative approaches for the coming decade. This meeting put into focus the importance of an adequate genetic approach to several areas of research: the search for the genetic determinants underlying new susceptibilities, th...
Archives of Osteoporosis, 2009
Giant cell tumor (GCT) of the bone, also called osteoclastoma, is a rare complication of Paget's ... more Giant cell tumor (GCT) of the bone, also called osteoclastoma, is a rare complication of Paget's bone disease. We report a patient from Southern Italy who developed a GCT infiltrating the neighboring tissues. The natural history and the therapeutic outcomes of this unique complication of Paget's bone disease are presented.
New England Journal of Medicine, 2004
Osteoporotic structural damage and bone fragility result from reduced bone formation and increase... more Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption. In a phase 2 clinical trial, strontium ranelate, an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption, has been shown to reduce the risk of vertebral fractures and to increase bone mineral density. methods To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial, we randomly assigned 1649 postmenopausal women with osteoporosis (low bone mineral density) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years. We gave calcium and vitamin D supplements to both groups before and during the study. Vertebral radiographs were obtained annually, and measurements of bone mineral density were performed every six months. results New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group, with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period (relative risk, 0.59; 95 percent confidence interval, 0.48 to 0.73). Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck (P<0.001 for both comparisons). There were no significant differences between the groups in the incidence of serious adverse events. conclusions Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures.
Current Medical Research and Opinion, Oct 7, 2005
Since chronic low back pain (CLBP) is a complex biopsychosocial problem the ideal treatment is mu... more Since chronic low back pain (CLBP) is a complex biopsychosocial problem the ideal treatment is multimodal and multidisciplinary. However, in many countries, primary-care physicians care for many people with CLBP and have a pivotal role in selecting patients for more intensive treatments when these are available. Guidelines on the general use of strong opioids in chronic non-cancer pain have been published but, until now, no specific guidelines were available on their use in chronic low back pain. Given the prevalence of CLBP, and the complex nature of this multifactorial condition, it was felt that specific, evidence-based recommendations, with a focus on primary-care treatment, would be helpful. An expert panel drawn from across Europe including pain specialists, anaesthetists, neurologists, rheumatologists, a general practitioner, an epidemiologist and the chairman of a pain charity was therefore convened. The aim of the group was to develop evidence-based recommendations that could be used as a framework for more specific guidelines to reflect local differences in the availability of specialist pain services and in the legal status and availability of strong opioids. Statements were based on published evidence (identified by a literature search) wherever possible, and supported by clinical experience when suitable evidence was lacking. Strong opioids have a role in the treatment of low back pain when other treatments have failed. They should be prescribed as part of a multimodal, and ideally interdisciplinary, treatment plan. The aim of treatment should be to relieve pain and facilitate rehabilitation.
Contributions to nephrology
Recenti progressi in medicina
Clinical and experimental rheumatology
To describe the effects of two consecutive intravenous infusions of aminohexane bisphosphonate (N... more To describe the effects of two consecutive intravenous infusions of aminohexane bisphosphonate (Neridronate) in patients with active Paget&#39;s disease of bone. The study population included 83 patients, aged 41 to 85 years, randomized to 4 cumulative doses of Neridronate (25, 50, 100, 200 mg) given over 2 days, with a follow up of 180 days. The baseline serum alkaline phosphatase activity was at least 10% above the upper limit of the laboratory range. The response to treatment was assessed by changes in the serum total alkaline phosphatase (primary end point of the study), bone alkaline phosphatase and N-telopeptide urinary excretion. All Neridronate doses significantly suppressed the biochemical indices of disease activity. The nadir of total alkaline phosphatase levels ranged from -16 % to -57.5% of pretreatment values in the four groups, with a dose-response relationship that was apparent even between the two highest doses. The proportion of patients still maintaining a partial response (decreases in serum total alkaline phosphatase &gt;25%) at the 6 month follow-up was also related to the dose: 98%, 67%, 57%, 21% in the patients given 200, 100, 50, 25 mg respectively. The proportion of responders in terms of bone alkaline phosphatase and N-telopeptide excretion changes was similar. Bone pain attributed to Paget&#39;s disease was significantly reduced. A typical acute phase reaction (fever and/or arthromyalgia) occurred in 16 out of 83 patients. We conclude that all of the Neridronate doses tested here were well tolerated and effective in decreasing, in a dose-related manner the bone turnover parameters of Paget&#39;s disease. The highest dose (200 mg) resulted in the normalization of the markers of disease activity in more than 60% of the patients.
Osteoporosis International, 1996
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Papers by Sergio Ortolani