Comparative effects of treatment with etidronate and alendronate on bone resorption, back pain, and activities of daily living in elderly women with vertebral fractures.
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The purpose of the present study was to compare the effects of treatment with etidronate and alendronate on bone resorption, back pain, and activities of daily living (ADL) in elderly women with vertebral fractures. Fifty elderly women, 63-84 years of age, with back pain due to osteoporotic vertebral fractures were randomly divided into two groups with 25 patients in each group: the cyclical etidronate treatment group (200 mg/day for 2 weeks per 3 months) and the alendronate treatment group (5 mg/day). The level of urinary cross-linked N-terminal telopeptides of type I collagen (NTx) measured by an enzyme-linked immunosorbent assay, back pain evaluated with the face scale score, and the ADL score (disability) determined with a questionnaire were assessed before and 3 and 6 months after the start of treatment. No significant differences in these parameters were found between the two groups before the treatment. The urinary NTx level, the face scale score, and the ADL score decreased significantly in both groups. Although the reduction in the urinary NTx level was significantly greater in the alendronate group than in the etidronate group, the reduction in the face scale score was transiently significantly greater in the etidronate group than in the alendronate group. However, changes in the ADL score did not significantly differ between the two groups. The present study showed that although back pain was reduced and ADL was improved in both treatment groups of elderly women with vertebral fractures, the mechanism for the reduction in back pain differs to some extent between the two treatment groups. A double-blind placebo-controlled study is needed to confirm the therapeutic effects of these agents on back pain and deterioration of ADL. (+info)
Comparison of risedronate to alendronate and calcitonin for early reduction of nonvertebral fracture risk: results from a managed care administrative claims database.
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OBJECTIVE: Recent randomized clinical trials have shown that risedronate reduces the risk of nonvertebral fractures and clinical vertebral fractures within 6 months of initiating treatment. The objective of the current study was to determine whether this early antifracture effect could be demonstrated in nonvertebral fractures for risedronate and other osteoporosis therapies in an observational administrative claims database. METHODS: A proprietary administrative claims database was used to identify managed care members who received a new prescription for risedronate, alendronate, or nasal calcitonin from July 1, 2000, to December 31, 2001. Patient records were analyzed for the incidence of nonvertebral fractures (clavicle, humerus, wrist, pelvis, hip, and leg) in the first 6 and 12 months following initiation of treatment. A Cox proportional hazards regression model was used to estimate relative risk (RR) of fracture at 6 and 12 months. RESULTS: In the 6-month analysis, 774 patients (11%) received calcitonin, 5,307 (75%) received alendronate, and 1,000 (14%) received risedronate. Twelve-month data were available for a subset (71%) of patients (656 calcitonin [13%], 3,716 alendronate [74%], and 652 risedronate [13%]). Most were women (93%); mean age was similar for alendronate and risedronate, and nasal calcitonin patients were about 3 years older, on average. Risedronate and alendronate patients were more likely to have used estrogen, while nasal calcitonin patients were more likely to have been hospitalized and had higher use of concomitant medications and more physician visits. Relative risks were adjusted for these differences. Risedronate and alendronate patients were similar with respect to these indicators of general health status. In the 6-month analysis, nonvertebral fractures were observed in 2.2% of patients receiving nasal calcitonin, 1.4% of patients receiving alendronate, and 0.6% of patients receiving risedronate. The adjusted RR reduction was 69% for risedronate versus calcitonin (RR = 0.31; 95% CI, 0.12 to 0.81; P = 0.02), 54% for risedronate versus alendronate (RR = 0.46; 95% CI, 0.20 to 1.06; P = 0.07), and 26% for alendronate versus calcitonin (RR = 0.74; 95% CI, 0.43 to 1.27; P = 0.28). In the 12-month analysis, nonvertebral fracture rates were 2.9% for nasal calcitonin, 2.4% for alendronate, and 0.9% for risedronate patients. The adjusted RR reduction was 75% for risedronate versus calcitonin (RR = 0.25; 95% CI, 0.10 to 0.64; P<0.01), 59% for risedronate versus alendronate (RR = 0.41; 95% CI, 0.18 to 0.94; P = 0.04), and 25% for alendronate versus calcitonin (RR = 0.75; 95% CI, 0.45 to 1.25; P = 0.27). CONCLUSIONS: This analysis of medical and pharmacy claims contained in an administrative database confirms the early fracture reduction with risedronate that was shown in randomized clinical trials. Risedronate was more effective than calcitonin in reducing the risk of nonvertebral fractures within the first 6 months of treatment. Risedronate was more effective than either calcitonin or alendronate in reducing the risk of nonvertebral fractures within 12 months of treatment. (+info)
Differential effect of short-term etidronate treatment on three cancellous bone sites in orchidectomized adult rats.
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The aim of the present study was to analyze the effects of short-term treatment with the antiresorptive agent, etidronate, on orchidectomized adult rats, via comparison of three cancellous bone sites, the lumbar vertebral body (LVB), proximal tibial metaphysis (PTM), and distal tibial metaphysis (DTM). Thirty-five male Wistar rats, aged 10 months, were randomly divided into four groups: baseline control (BLC, nF10), age-matched sham-operated control (AMC, nF9), orchidectomy (ORX, nF9), and ORXBetidronate treatment (nF7). Etidronate treatment (10 mg/kg, daily subcutaneous injection) was initiated 2 weeks after surgery and was continued for 2 weeks. Four weeks after surgery, the 5th LVB, PTM, and DTM were processed for histomorphometric analysis of cancellous bone (secondary spongiosa). ORX resulted in a decrease in body weight. No significant difference in cancellous bone volume (BV/TV) was found between the BLC and AMC groups at any skeletal site. The cancellous BV/TV loss was attributable to increased eroded surface (ES/BS) with no significant alteration in the mineral apposition rate (MAR), at all skeletal sites and etidronate treatment in ORX rats significantly decreased ES/BS to a level not significantly different from that in the AMC group, resulting in complete prevention of ORX-induced cancellous BV/TV loss. The MAR was markedly decreased in the PTM and LVB, but maintained in the DTM by etidronate treatment. The present study showed that etidronate treatment could completely prevent ORX-induced cancellous bone loss regardless skeletal sites by suppressing bone resorption. In particular, suppression of bone formation in terms of osteoblastic activity by etidronate treatment was not evident only in the DTM (+info)
Effects of ethane-1-hydroxy-1,1-diphosphonate on ossification of the posterior longitudinal ligament in Zucker fatty rats.
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PURPOSE: Using Zucker fatty rats as an animal model, we evaluate the effectiveness of ethane-1-hydroxy-1,1-diphosphonate on ossification of the posterior longitudinal ligament by histopathologically investigating the prodromal, early, and advanced stages of ossification of the spinal ligaments. METHODS: 73 Zucker fatty rats were allocated to the ethane-1-hydroxy-1,1-diphosphonate group (n=33) and the control group (n=40). The former group was fed ethane-1-hydroxy-1,1-diphosphonate daily. The feed was given starting 2 months after birth and continued until the rats were killed at 3 to 18 months later. Chemical analysis of the blood, radiographic tests, and histopathological examination were then conducted for both groups. RESULTS: The results showed that ossification of the spinal ligaments involved excessive cartilage cell proliferation around areas affected by enthesitis; enlargement of the fibrocartilage tissue layer; ligament thickening; calcification of the matrix around the cartilage cells; and ossification of the spinal ligaments through enchondral ossification. Radiographic examinations showed that osteoproliferation in vertebral bodies in rats receiving ethane-1-hydroxy-1,1-diphosphonate was generally suppressed compared with controls, whereas histopathological examinations found no clear difference in cartilage cell proliferation in areas affected by enthesitis between the two groups, indicating the absence of calcification or osteo-proliferation in areas affected by enthesitis for the rats receiving ethane-1-hydroxy-1,1-diphosphonate. CONCLUSION: Ethane-1-hydroxy-1,1-diphosphonate is effective in suppressing progressive ligament ossification. (+info)
Prevention of trabecular bone loss in the mandible of ovariectomized rats.
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The effect of therapeutic agents on trabecular bone loss in the mandible was investigated in ovariectomized rats. Eighty-seven Wistar SPF female rats were ovariectomized (OVX) or given a sham operation (Sham), and maintained on a diet containing 0.1% calcium. Four weeks later, groups of OVX rats were treated with estriol (E3), calcitonin (CT), etidronate, or 2-carboxyethylgermanium sesquioxide (Ge-132). The Basal group was maintained on a diet containing 1.0% calcium, and the OVX and sham groups on a diet containing 0.1% calcium. The trabecular bone mineral density (BMD) and trabecular bone mineral content (BMC) in 11 mandibular slices from 0.5 mm at the mesial margin of the first molar to 0.5 mm at the distal margin of the third molar, were measured using peripheral Quantitative Computed Tomography (pQCT). The BMD in the OVX group was lower than that in the Sham group, and decreased BMC was observed only in the molar region. BMD and BMC were increased in the etidronate-treated group, but only BMC was increased in the CT group. E3 treatment increased BMD and BMC; significant increases were also observed beneath the molar. Ge-132 treatment increased both BMD and BMC, especially the latter. (+info)
Five year study of etidronate and/or calcium as prevention and treatment for osteoporosis and fractures in patients with asthma receiving long term oral and/or inhaled glucocorticoids.
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BACKGROUND: Glucocorticoids are associated with a reduction in bone density and an increased risk of fracture. Concurrent treatment with bisphosphonates reduces bone loss and may prevent fractures. A randomised study was performed to determine whether treatment with cyclical etidronate and/or calcium for 5 years prevents fractures or reverses/reduces bone loss in patients receiving glucocorticoid treatment for asthma. METHODS: A multicentre, randomised, parallel group comparison of etidronate alone, calcium alone, etidronate + calcium, and no treatment, with stratification according to level of glucocorticoid exposure was carried out in 39 chest clinics in the UK. Three hundred and forty nine postmenopausal female and male outpatients with asthma aged 50-70 years were randomised. The main outcome measures were fractures and changes in bone mineral density (BMD). RESULTS: Overall, 8% of the patients experienced symptomatic fractures and 17.5% developed either a symptomatic fracture and/or a semiquantitative vertebral fracture by the end of 5 years There were no significant differences between the four treatment groups. Comparing etidronate with no etidronate, the rates of new fractures were not significantly different for symptomatic fractures (OR 1.07 (95% CI 0.46 to 2.47)) or for any fractures (OR 0.82 (95% CI 0.45 to 1.47)). For the comparison of calcium with no calcium the corresponding ORs were 1.43 (95% CI 0.62 to 3.33) and 0.91 (95% CI 0.50 to 1.63). In post hoc analysis the effect of etidronate was greater in women than in men (interaction p value 0.02) with the fracture incidence roughly halved (OR 0.39, 95% CI 0.14 to 0.99). Etidronate increased BMD at the lumbar spine by 4.1% (p = 0.001) while calcium had no significant effect. At the proximal femur the effects of treatment were not significant (relative increases etidronate 1.6%; calcium 1.1%). The rate of new fractures in patients with fractures at entry (23.7%) was higher than in those without fractures at entry (14.3%): OR 1.87 (95% CI 1.06 to 3.07). No association was found between change in BMD and new fractures. CONCLUSIONS: In patients receiving glucocorticoids for asthma etidronate significantly increased BMD over 5 years at the lumbar spine but not at the hip and had little if any protective effect against fractures, except possibly in postmenopausal women. The effects of calcium were not significant. Combination treatment had no advantage but increased unwanted effects. (+info)
Palliative treatment of painful disseminated bone metastases with 186Rhenium-HEDP in patients with lung cancer.
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AIM: The aim of this study was to determine if patients with lung cancer and metastatic bone pain due to disseminated secondary bone disease, can benefit from the treatment with (186)Re-HEDP and to discuss the criteria useful for selecting those patients. METHODS: Twenty-four patients were included in this study and they received 1295 MBq (186)Re-HEDP. All patients underwent (99m)Tc-MDP bone scan before treatment from which the bone scan index (BSI) was determined (mean=18.7+/-17.1%). Most patients underwent CT scan of the painful areas from which the osteolytic element of their bone lesions as well as possible infiltration of the soft tissues was determined. Patients with predominantly osteolytic metastases at the sites considered to be the origin of pain in the CT scan, were excluded. All patients were under analgesic therapy, 22/24 were taking opiates. Pain was estimated by the visual analogue scale (VAS) before the application of (186)Re-HEDP and over the following 8 weeks. The possible myelotoxicity of (186)Re was assessed. RESULTS: The mean VAS score was 6.9+/-2.5 before the application and 3.2+/-2.6 after therapy. Pain relief was obtained in 23/24 patients. Sixty-two percent of the patients exhibited clinically significant pain relief of at least 3 VAS score. The dosage of opiates was decreased in 77% of the patients and could be discontinued in 4 of them. Myelotoxicity was observed in 1 patient. Ninety-one percent of our patients showed improvement in the parameters that assess the quality of life. CONCLUSION: The application of a standard dose of (186)Re-HEDP in patients with lung cancer and painful disseminated bone metastases has a satisfactory pain alleviating effect. The easy application and very low myelotoxicity are important factors in this group of patients. A better analgesic effect of the (186)Re-HEDP application can be expected if combined estimation of the (99m)Tc-MDP bone scan and the CT scan is used. (+info)
Pharmacologic prevention of osteoporotic fractures.
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Osteoporosis is characterized by low bone mineral density and a deterioration in the microarchitecture of bone that increases its susceptibility to fracture. The World Health Organization defines osteoporosis as a bone mineral density that is 2.5 standard deviations or more below the reference mean for healthy, young white women. The prevalence of osteoporosis in black women is one half that in white and Hispanic women. In white women 50 years and older, the risk of osteoporotic fracture is nearly 40 percent over their remaining lifetime. Of the drugs that have been approved for the prevention or treatment of osteoporosis, the bisphosphonates (risedronate and alendronate) are most effective in reducing the risk of vertebral and nonvertebral fractures. Risedronate has been shown to reduce fracture risk within one year in postmenopausal women with osteoporosis and in patients with glucocorticoid-induced osteoporosis. Hormone therapy reduces fracture risk, but the benefits may not outweigh the reported risks. Teriparatide, a recombinant human parathyroid hormone, reduces the risk of new fractures and is indicated for use in patients with severe osteoporosis. Raloxifene has been shown to lower the incidence of vertebral fractures in women with osteoporosis. Salmon calcitonin is reserved for use in patients who cannot tolerate bisphosphonates or hormone therapy. (+info)