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S Ortolani

Publications and source records attributed to S Ortolani.

At least 37 records · Page 2Linked to original sources
PubMed1995

Evaluation of therapeutic efficacy in osteoporosis.

Evaluation of the efficacy of osteoporosis treatments poses a major challenge for clinical investigators. This paper addresses the question of whether increases in bone mass induced by therapy for osteoporosis are sufficient to determine the efficacy of that therapy, or whether long-term fracture endpoint studies are required. Osteoporosis has been defined as a systematic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. This association between bone mass and fracture risk has been found to be stronger than other well-recognized risk factor associations, such as blood pressure and risk of stroke. Although fracture endpoint studies would provide confirmation of the benefit of osteoporosis therapy, such trials require that several thousand patients be studied for many years, making such studies impractical as a means for providing data for the approval of new therapies. Determination of increased bone mass may provide data that are just as useful in evaluating therapeutic efficacy. The use of bone mass as the primary efficacy endpoint for those therapies that are associated with normal bone quality is justified by the well-documented relationship between bone mass and fracture risk observed in several epidemiological studies.

Bone Density↗
PubMed1995

Rationale for the use of alendronate in osteoporosis.

Bisphosphonates are being used in disorders associated with accelerated resorption of bone, particularly Paget's disease of bone and the bone disease of malignancy. Their undoubted biological efficacy and relatively low apparent toxicity make them attractive candidates for the management of osteoporosis. The bisphosphonate alendronate has many characteristics which suggest that it is suitable for use in osteoporosis. It is a potent inhibitor of osteoclast-mediated bone resorption with no adverse effect on the mineralization of bone. Earlier studies have shown it to be one of the most active bisphosphonates in Paget's disease and the hypercalcemia of malignancy. In common with other bisphosphonates tested thus far, alendronate appears to inhibit bone loss in a variety of experimental models of osteoporosis. Long-term studies are needed to determine its steady-state effects on bone mass in man. Most data indicate that alendronate is capable at least of decreasing the rate of bone loss, and might even induce increments in bone mass for many years. Since the experimental studies show that the increase in bone mass observed with alendronate is associated with an increase in bone strength, its use is likely to decrease the frequency of fractures. However, direct clinical evidence for this requires the outcome of well-designed long-term prospective studies.

Alendronate↗
PubMed1995

Effects of oral alendronate and intranasal salmon calcitonin on bone mass and biochemical markers of bone turnover in postmenopausal women with osteoporosis.

The main objective of this study was to determine the effect of daily oral alendronate treatment on bone mass in postmenopausal women affected by osteoporosis. The efficacy of intranasal salmon calcitonin was also examined. Nine centers in Italy enrolled 286 postmenopausal women between the ages of 48 and 76 with spinal bone mineral density > or = 2 SD below adult mean peak in the two-year, double-blind, randomized, placebo-controlled trial. Patients were randomized to one of four treatment arms: double-blind placebo, alendronate 10 mg/day, alendronate 20 mg/day, or open-label intranasal salmon calcitonin 100 IU/day; all patients received 500 mg Ca++ supplements. Bone mass was measured by dual-energy x-ray absorptiometry every six months for two years. Patients who received alendronate 10 or 20 mg experienced significant increases in bone mass at all sites measured. At the end of the second year, the mean percent changes, for alendronate 10 and 20 mg relative to placebo, were 5.2% and 7.3% at the lumbar spine, 3.8% and 4.6% at the femoral neck, and 7.1% and 7.5% at the trochanter, respectively. In contrast, intranasal salmon calcitonin failed to increase bone mineral mass significantly at any site. Both alendronate doses significantly decreased serum alkaline phosphatase, serum osteocalcin, and urinary pyridinolines, markers of bone turnover, whereas placebo and intranasal calcitonin did not. Alendronate was generally well tolerated and no serious adverse events were attributed to its use.(ABSTRACT TRUNCATED AT 250 WORDS)

Absorptiometry, Photon↗
PubMed1994

Calcitriol and calcium carbonate therapy in early chronic renal failure.

The aim of this study was to evaluate the effects of a combined low-dose therapy of calcitriol and calcium carbonate on bone metabolism in the early phases of chronic renal failure. A 30-month study involving 17 patients with ECRF was made: 6 months of observation were followed by 24 months of therapy (calcitriol 0.25 microgram/day plus calcium carbonate 1 g/day). The most important results were that renal function was stable throughout the study and there was an increase in calcaemia and a decrease in plasma alkaline phosphatase, plasma osteocalcin, plasma PTH and urinary hydroxyproline. We observed a progressive slowing of the rate of loss of appendicular bone density as well as a decrease of osteoblastic and osteoclastic activity and an improvement of bone mineralization. In conclusion, low doses of calcitriol plus calcium carbonate seem to improve the biochemical and bone derangements in early renal failure.

Adult↗
PubMed1993

Dual X-ray absorptiometry for the evaluation of bone density from the proximal femur after total hip arthroplasty: analysis protocols and reproducibility.

Dual X-ray absorptiometry (DXA) instruments are now able to evaluate bone mineral density (BMD) of bone surrounding metal implants. The assessment of BMD around prosthetic components could provide additional information for the follow-up of total hip arthroplasty (THA). In this study, we evaluated the potential application of DXA in the field of THA. BMD was measured in the proximal femur of both THA and THA-free sides in 14 postmenopausal women 6-18 months after THA. The explored segment was divided into seven zones as proposed by Gruen et al. [18]. The precision error of BMD measurements ranged from 1.8 to 6.8% on the THA side and from 1.1 to 2% to the THA-free side. The reduction of BMD of the THA versus the THA-free side was significant in all seven zones (P < 0.01, t-test for paired data). These results showed significant differences in BMD around femoral components of THA with respect to contralateral healthy side, and demonstrate the sensitivity of DXA for detecting these changes.

Absorptiometry, Photon↗
PubMed1993

Treatment of postmenopausal osteoporosis with continuous daily oral alendronate in comparison with either placebo or intranasal salmon calcitonin.

Alendronate sodium (ALN) is a potent amino bisphosphonate which specifically inhibits osteoclastic bone resorption and has been found to reverse bone loss in several animal models. To determine if daily oral ALN treatment could prevent or reverse bone loss in osteoporotic postmenopausal women, and to compare ALN to intranasal salmon calcitonin (CT), a 2-year, double-masked, randomized, placebo-controlled study was initiated at 9 clinical centers in Italy. Two hundred and eighty six postmenopausal women (age 48-76) with spinal bone mineral density (BMD) > or = 2 SD below adult mean peak, with or without vertebral crush fractures, were randomized to one of four treatment arms: ALN 10 mg daily, ALN 20 mg daily or matching placebo (these groups all double-masked), or CT 100 IU daily (open label) for 2 years. All patients received supplemental calcium (as carbonate) 500 mg daily. Bone mass was measured by dual-energy X-ray absorptiometry of the PA lumbar spine (LS) and proximal femur (femoral neck and trochanter) at 6-month intervals. Subject safety was measured through sequential clinical and laboratory evaluation. A planned 1-year interim analysis of this ongoing study was performed centrally in a manner that maintains the double-mask for all subjects receiving oral study drug. Relative to PBO, ALN at either 10 mg or 20 mg daily increased LS BMD by 4.7% and 6.1%, respectively; each increased femoral neck BMD by 3.1% and increased trochanter BMD by 3.3% and 3.8% respectively. In contrast, CT failed to significantly increase BMD of either the spine, femoral neck or trochanter, either relative to baseline or to PBO.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intranasal↗
PubMed1992

Bone mass measurement by DXA: influence of analysis procedures and interunit variation.

Interunit variability among bone densitometers is due to different factors, including different calibration procedures and algorithms and variability in photon source energies and/or intensities. Other factors, such as the choice of scan parameters or the analysis procedures, can also introduce variability. The new generation of dual-energy x-ray absorptiometry (DXA) has partially improved this situation. The aim of this study was to investigate the operator-dependent analysis procedures that can affect scan results and to evaluate the phantom and in vivo interunit variation of some DXA instruments. Four DXA instruments (QDR 1000 and 1000/W, Hologic, Inc.) were used. Potential sources of variability in the analysis procedures of anteroposterior lumbar spine and hip scans were considered: in most cases these procedures significantly influenced scan results. On lumbar spine, an enlargement of the scan window of less than 3 cm was responsible for an average increase in bone mineral density (BMD) of about 3%. On the hip, lowering the scan window by about 1 cm accounted for an increase in the whole-segment BMD of about 4%. After standardization of analysis procedures, interunit and intraunit coefficients of variation and percentage differences among instruments were less than 1% for all the parameters considered (area and bone mineral content and density) with both an anatomic and a geometric phantom, and in nine subjects scanned by two different devices the percentage difference in BMD was greater than 2%. This study shows that present interunit variability allows comparisons among laboratories, but only if highly standardized analysis procedures are used.

Absorptiometry, Photon↗
PubMed1992

Effects of ipriflavone on bone mass and calcium metabolism in postmenopausal osteoporosis.

Recently it has been demonstrated that ipriflavone (IP), an isoflavone derivative, is able to increase bone mass in patients with established postmenopausal osteoporosis (PMO). Here we present a preliminary report of a 2-year multicenter, double-blind, placebo-controlled clinical study performed in order to evaluate the efficacy and tolerability of IP in PMO. A large number of patients with PMO, referred to 12 Italian centers, was randomly divided into 2 groups and treated with oral IP (600 mg/day) or placebo (Pl). All patients received an oral Ca supplement (1 g/day). One hundred and twenty six patients completed 1 year of the study. Bone mineral density (BMD) of the distal radius, measured by DPA, serum osteocalcin (BGP), and urinary hydroxyproline excretion (HOP/Cr), were measured before and after 12 months. After 12 months, a significant increase in BMD was observed in the IP-treated group (P < 0.05). IP determined a reduction of HOP/Cr, while in Pl-treated patients a significant increase of this index, as well as of BGP, was observed. After 12 months the difference between the two groups resulted significant (P < 0.05) for BGP. The drug was well tolerated and the patients' compliance to the oral treatment resulted excellent. The results of this study indicate that IP is able to increase bone mass in patients with PMO.

Aged↗
PubMed1992

Bone mass status in different degrees of chronic renal failure.

Bone mineral density (BMD) was evaluated in 69 patients with chronic renal failure (CRF) and in healthy controls matched for age, sex, and, for women, menopausal status. Both appendicular (predominantly cortical) and axial (predominantly trabecular) bone mass were measured. Appendicular BMD was measured by single photon absorptiometry on the distal forearm and axial BMD was measured by dual photon absorptiometry on the lumbar spine. Patients were divided into three groups on the basis of creatinine clearance: group 1, 58 to 36 ml/min; group 2, 30 to 18 ml/min; group 3, 15 to 9 ml/min. Both appendicular and axial BMD decreased with the worsening of renal failure. Parathyroid hormone levels were inversely correlated with the values of appendicular BMD. BMD values were significantly lower in postmenopausal than in premenopausal women. Months of menopause were inversely correlated with axial BMD values. Appendicular BMD was lower in CRF patients than in controls, and both appendicular and axial BMD were significantly lower in postmenopausal uremic women than in postmenopausal healthy women.

Absorptiometry, Photon↗
PubMed1991

Cyclic hormonal replacement therapy after the menopause: transdermal versus oral treatment.

In an open, randomized, comparative, between-patient trial, 45 postmenopausal women were treated for 4 months with cyclical transdermal oestradiol 0.05 mg per day or oral conjugated equine oestrogens 0.625 mg per day, in both cases, plus, medroxyprogesterone acetate 10 mg per day on the last 8 days of each cycle. Similar relief from postmenopausal symptoms was obtained with both treatments. Post-treatment histological evaluation of the endometrium did not reveal neoplastic or hyperplastic change in any patient. Early follicular-phase plasma oestradiol levels were observed only after transdermal oestradiol. There was a significant reduction in serum total cholesterol and LDL cholesterol in both treatment groups, with no difference between treatments, whereas serum triglyceride levels were decreased only by transdermal oestradiol. Plasma calcium and phosphorus fell significantly and serum intact parathyroid hormone rose significantly, with no difference between the therapies. No significant changes were observed in clotting factors. Transdermal oestradiol appears to be an effective and safe hormonal replacement therapy, and this route of administration may be responsible for the more useful action of the drug on serum lipids and plasma oestradiol levels.

Administration, Cutaneous↗
PubMed1991

Age, time since menopause, and body parameters as determinants of female spinal bone mass: a mathematical model.

The study of mathematical models to describe bone mass behavior throughout life is a possibility for assessing the main factors of peak bone mass and bone loss. We developed a mathematical model to predict spinal bone mass behavior on a sample of 181 healthy Italian women whose lumbar bone mineral content was determined by Gd-153 dual photon absorptiometry. This model proved to be both efficient, showing the best fit (r = 0.7 on spinal bone mineral content) when compared to other previously suggested models, and also reliable as its fit remained the best when applied to a subsequent sample of 519 women whose lumbar spine was measured by dual X-ray photon absorptiometry. This model suggests that body height and body weight (but not age) are determinants of bone mass in premenopausal women. In postmenopausal women, an accelerated phase of bone loss starting at menopause is dependent on age and time since menopause, whereas body mass index acts as a protective factor. This model confirms the influence on spinal bone mass not only of age and time since menopause but also of body size parameters.

Absorptiometry, Photon↗
PubMed1991

Spinal and forearm bone mass in relation to ageing and menopause in healthy Italian women.

Most studies concerning bone status have been performed in Nordic and Anglo-Saxon countries and few data are available on southern European populations. We performed a cross-sectional study on spine and forearm bone mass in 234 healthy Italian women and related the results to age and time since menopause. Forearm bone mass does not decline in premenopausal age, whereas, as far as the spine is concerned, a significant reduction appears 3 years before the mean age of menopause; in both cases, the occurrence of menopause accounted for an accelerated phase of bone loss. In postmenopausal women both spine and forearm bone mass show a stronger correlation with years since menopause than with age. According to a linear exponential model, the rate of spinal bone loss per year since menopause is around 4% in the first 3 years which slows down to around 2% in the 5th year; the corresponding rates of forearm bone loss are 2% and 1.3%, respectively.

Adult↗
PubMed1991

Gonadotropin releasing hormone agonist therapy and its effect on bone mass.

The effects on bone mass of a 6 month therapeutic cycle with a gonadotropin releasing hormone agonist (GnRHa) were studied in 22 patients, ten affected by pelvic endometriosis and 12 by uterine fibroids. All patients were subjected to preliminary full examinations to confirm their diagnosis (laparoscopy for the endometriosis group and precise ultrasound volume measurements for uterine fibroids group). Before the beginning of treatment, bone mineral density (BMD) was measured in each patient both on the distal third of the forearm, with single-photon absorptiometry, and on the lumbar spine (L1-L4), with dual photon absorptiometry. The gonadotropin releasing hormone agonist used was buserelin. In the first week of therapy 0.5 mg of the drug was administered subcutaneously thrice daily. In the following 25 weeks the same drug was given intranasally, at a dosage of 300 micrograms again three times a day. Bone mass measurements, both at the peripheral and at the axial site, were repeated at the end of the 26-week therapeutic cycle and then again 6 months later. At the 26th week, a significant decrease of BMD was observed at both sites. The loss was 1.5% (p less than 0.05) on the lumbar spine, and 2.1% (p less than 0.05) on the radius. No bone mass restoration took place in the following 6 months. On the contrary, a less significant but discernible trend towards a further bone loss was apparent in the BMD values measured 6 months after the end of therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1990

Vitamin D metabolites in spasmophilia.

The comparison of 20 untreated spasmophilic patients (2 men, 18 women) with 25 healthy subjects revealed no significant differences in vitamin D metabolite plasma levels or in other laboratory indexes of calcium metabolism except for ionized and cytosolic free calcium levels which were lower in the former group (P less than 0.01; P less than 0.001). After 3 months treatment with calcitonin and 25-hydroxyvitamin D there was a clear improvement in patient symptoms, no significant modification of 1,25-dihydroxyvitamin D levels and significant increases in 25-hydroxyvitamin D, cytosolic free calcium and urinary calcium (P less than 0.001, P less than 0.001 and P less than 0.01, respectively). We conclude that high plasma levels of 25-hydroxyvitamin D play an important role in restoring normal cytosolic free calcium levels and reducing clinical manifestations in spasmophilia.

Adult↗