The bone mineral content of individual lumbar vertebrae was determined, and bone mineral density (expressed in grams per square centimeter) was calculated by dividing the bone mineral content by the area of the vertebra.

The method of linear contrasts was used to make paired comparisons: group 1 versus group 3, group 1 versus group 4, group 2 versus group 4, and group 3 versus group 4. There were no significant differences in serum calcium, creatinine, or phosphorus levels or urinary calcium:creatinine or hydroxyproline:creatinine ratios between treatment groups during the study. Tou, and Dr. J.M.

The asterisk (P = 0.014) and the dagger (P = 0.002) indicate significant differences between treatment groups.

The results are expressed as the means SE and reflect results from all patients who began the study regimen.

. 2. Case Records of the Massachusetts General Hospital, Protection Associated with Previous SARS-CoV-2 Infection in Nicaragua, Nirmatrelvir for Nonhospitalized Adults with Covid-19, Efficacy of Antibodies and Antiviral Drugs against Omicron BA.2.12.1, BA.4, and BA.5 Subvariants, Effectiveness of BNT162b2 Vaccine against Omicron in Children 5 to 11 Years of Age, Evidence for Step Therapy in Diabetic Macular Edema, Aflibercept Monotherapy or Bevacizumab First for Diabetic Macular Edema, Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer, Adagrasib in NonSmall-Cell Lung Cancer Harboring a, Phase 12 Trial of AAVS3 Gene Therapy in Patients with Hemophilia B, BNT162b2 Vaccine Effectiveness against Omicron in Children 5 to 11 Years of Age, Tirzepatide Once Weekly for the Treatment of Obesity, NEJM Catalyst Innovations in Care Delivery. Presented in part at the 10th International Conference on Calcium Regulating Hormones, Montreal, Canada, September 14, 1989. In: Christiansen C, Johansen JS, Riis BJ, eds.

Thus, the search continues for an inexpensive, safe, and effective treatment for osteoporosis. . This suggests that intermittent cyclical therapy with etidronate provides the greatest protection against fracture in patients who have already had substantial losses in vertebral bone mineral density. All instruments measured bone mineral content within 5 percent of the nominal value. ); University of California, San Francisco (S.T.H., H.K.G., P.S. .

The administration of phosphate was associated with diarrhea in 39 percent of the patients, and phosphate used alone was associated with a decrease in bone mass of the hip. ADFR, or coherence therapy for osteoporosis. Au and Dr. J.A. Lindsay R, Hart DM, Aitken JM, MacDonald EB, Anderson JB, Clarke achal.

. No correlations were found between the changes in bone mineral density at these two skeletal sites in any treatment group (data not shown). Serum levels of parathyroid hormone increased significantly in the phosphate-treated patients; thus, activation may have occurred. Parathyroid hormone measurements were converted to Z scores, assuming that the reference range for each assay represented 2 SD.

Each patient received 1.0 g of phosphate (four sodiumpotassium phosphate tablets, each containing 250 mg of phosphate) or placebo twice daily for 3 days and 400 mg of etidronate (Didronel) or placebo daily for the next 14 days, followed by 500 mg of calcium (as calcium carbonate) daily for the next 74 days.

The withdrawals were divided among the four treatment groups as follows: 15 from group 1, 18 from group 2, 13 from group 3, and 14 from group 4. J Bone Miner Res 1988; 3:111.

The rate of new vertebral fractures was reduced by two thirds in the subgroup with low bone mineral density that received etidronate as compared with the subgroup that did not.

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results?

The rates of new vertebral fractures were significantly lower in the subgroups with low bone mineral density that received etidronate than in the subgroups that did not (Table 4).

The combination of phosphate and etidronate resulted in no apparent additional benefits beyond those offered by etidronate alone.

15. 25. 12. Clin Pharmacol Ther 1976; 20:593604. Long-term calcitonin therapy in postmenopausal osteoporosis .

The vertebral-fracture rate was reduced by two thirds in the etidronate-treated subgroup with low bone mineral density (42.3 fractures per 1000 patient-years in the patients who received etidronate as compared with 132.7 fractures per 1000 patient-years in those who did not; P = 0.004) (Table 4 and Fig. 23.

. Radiology 1980; 136:4857.

et al. In: Christiansen C, Johansen JS, Riis BJ, eds.

Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. However, calcium intake during the free period of our study was not excessive (an estimated 700 mg of dietary calcium plus 500 mg of supplemental calcium), and serum levels of parathyroid hormone were not suppressed during the 24 months of the study.

The bone density of the spine was measured by dual-photon absorptiometry, and the rates of new vertebral fractures were determined from sequential radiographs.

Long-term prevention of postmenopausal osteoporosis by oestrogen: evidence for an increased bone mass after delayed onset of oestrogen treatment .

The most trusted, influential source of new medical knowledge and clinical best practices in the world.

J Clin Endocrinol Metab 1988; 66:74753.

The bone mass of the lumbar spine, hip, and radius was measured at base line and every six months thereafter.

However, bone mineral density (calculated as bone mineral content divided by area) varied more widely because of differences in edge-detection algorithms. No serious side effects or deleterious effects at other skeletal sites were found. Lancet 1982; 2:6078. A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. Women who had been treated with estrogens, glucocorticoids, androgens, anabolic steroids, phosphate, or pharmacologic doses of calcium (more than 1.0 g daily) or vitamin D (more than 1000 IU daily) during the preceding six months or with a thiazide diuretic during the preceding two months were excluded.

16. Talk with your doctor and family members or friends about deciding to join a study.

); and the University of Washington, Seattle (C.H.C.).

Scott Med J. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Effects of cyclical therapy for osteoporosis using an oral regimen of inorganic phosphate and sodium etidronate: a clinical and bone histomorphometric study .

The results in the subgroups with low bone mineral density were similarly pooled for analysis.

8.

Each patient's series of films was displayed simultaneously on adjacent viewboxes in chronologic order. The effects of etidronate on bone mass were most pronounced in the spine, a site rich in trabecular bone. Lancet 1976; 1:103841. The gadolinium153 sources were replaced at one-year intervals to avoid measurements with weak sources and to synchronize source changes with the schedule for dual-photon-absorptiometry measurements (every six months).

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

Riggs BL, Hodgson SF, O'Fallon WM. NEW! Etidronate disodium in postmenopausal osteoporosis .

Intermittent cyclical therapy with etidronate for two years significantly increases spinal bone mass and reduces the incidence of new vertebral fractures in women with postmenopausal osteoporosis. The authorized source of trusted medical research and education for the Chinese-language medical community. .

11.

Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services.

No significant differences in the changes in spinal bone mineral density were detected between the subgroups with low bone mineral density and the corresponding full-treatment groups.

The non-vertebral fractures that could be attributed to osteoporosis were distributed across treatment groups: three hip fractures (one in group 3 and two in group 4), two pelvic fractures (one each in groups 1 and 3), and four wrist fractures (two each in groups 2 and 3).

The patients were asked to report suspected adverse effects by telephone and were questioned about symptoms and intercurrent illnesses at each visit.

An assigned significance level of 0.05 was used except in efficacy analyses involving comparisons at multiple time points. Chesnut CH III, Ivey JL, Gruber HE, et al.

2).

Fleisch H. . Wasnich RD, Ross PD, MacLean CJ, Davis JW, Vogel JM. Copenhagen: Osteopress ApS, 1987:11726.

Whether the observed positive effects and the apparent absence of side effects of etidronate therapy would be maintained for more than two years is not known; this protocol has been extended to address these questions. No calcium was given during the phosphate (or placebo) phase or the etidronate (or placebo) phase to avoid calcium-induced impairment of the absorption of phosphate or etidronate. Other exclusion criteria were an age of more than 75 years, weight below 40 kg or above 80 kg, secondary osteoporosis, and medical conditions that might confound study participation (i.e., active rheumatoid arthritis, active gastrointestinal or liver disease, chronic alcoholism, or renal impairment as evidenced by a serum creatinine level of more than 210 mol per liter). There were significantly fewer patients with new vertebral fractures and a 50 percent decrease in the rate of new vertebral fractures in the combined etidronate-treated groups as compared with the combined groups that did not receive etidronate.

There is an inverse relation between bone mineral density and the rate of vertebral fracture.20 21 22 23 This was confirmed in our study: 92 percent of the patients with new vertebral fractures were among the 50 percent with the lowest bone mineral density of the spine at base line. 20.

Clin Endocrinol (Oxf) 1986; 24:5762.

Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.

21. .

Diphosphonates and inhibition of bone mineralisation . The increase in spinal bone density did not occur as a result of losses of bone mass of the hip or wrist. Clin Orthop 1987; 217:728.



Nondecalcified, double-tetracyclinelabeled biopsy samples of bone were obtained at three centers (Atlanta, Denver, and Seattle) at entry and after two years of treatment.

New York: Elsevier, 1990:31520.

3. Safe and effective treatment of osteoporosis with intermittent slow release sodium fluoride: augmentation of vertebral bone mass and inhibition of fractures .

Involutional osteoporosis . Hesch RD, Heck J, Delling G, et al.

. (N Engl J Med 1990;323:739.).

Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis .

School of Clinical Medical Studies University of Newcastle, UK. Lancet 1987; 2:14813.

To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma. Detection of prefracture spinal osteoporosis using bone mineral absorptiometry .

26.

Calcif Tissue Int 1984; 36:3413.

Adverse drug effects were mild, generally infrequent, and evenly distributed among the treatment groups.

Urine (2hour or 24hour collections) was analyzed for calcium, creatinine, and total hydroxyproline concentrations at entry and every six months thereafter; urinary calcium and hydroxyproline levels were expressed relative to creatinine levels. In: Deluca HF, Mazess R, eds. The patients were randomly assigned to treatment with phosphate (1.0 g) or placebo twice daily on days 1 through 3, etidronate (400 mg) or placebo daily on days 4 through 17, and supplemental calcium (500 mg) daily on days 18 through 91 (group 1, placebo and placebo; group 2, phosphate and placebo; group 3, placebo and etidronate; and group 4, phosphate and etidronate). From Emory University School of Medicine, Atlanta (N.B.W., G.C.W.

The rates of new vertebral fractures were also lower in the groups that received etidronate (Table 3). The failure of the hip and wrist to mirror the improvement in bone mass noted in the spine was not unexpected; previous studies of therapy of osteoporosis4 , 24 have shown varying responses at skeletal sites with different proportions of trabecular and cortical bone, indicating that the response to treatment is not uniform at different skeletal sites.24. Intergroup comparisons were performed by one-way analysis of variance. .

Because of the small number of patients with new vertebral fractures in all four treatment groups, the results from the two etidronate-treated groups (groups 3 and 4) were pooled and compared with pooled data from the groups not receiving etidronate (groups 1 and 2).

Copenhagen: Osteopress ApS, 1987:3778.

Reginster JY, Denis D, Albert A, et al.

There were no significant changes in the bone mineral content of the distal and midshaft radius during the 24-month study period in any treatment group (data not shown).

At 24 months, the bone mineral density of the greater trochanter increased significantly from base line in group 3 (0.0190.005 g per square centimeter; P<0.017), and the bone mineral density of Ward's triangle decreased significantly in group 2 (-0.0200.006 g per square centimeter; P<0.017). .

1-Year controlled randomised (rial of prevention of early postmenopausal bone loss by intranasal calcitonin .

There were significantly fewer etidronatetreated patients with new vertebral fractures during the 24 months of the study (8 patients who received etidronate as compared with 17 patients who did not; P = 0.044) (Table 3).

Dual-photon absorptiometry with a gadolinium153 source18 , 19 was used to determine the bone mineral density of the lumbar spine (L1 to L4 at six centers and L2 to L4 at one center) and hip (the greater trochanter and Ward's triangle at six centers and the femoral neck at all centers). The most advanced way to teach, practice, and assess clinical reasoning skills. Osteoporosis: physiological basis, assessment, and treatment: proceedings of the Nineteenth Steenbock Symposium, June 58, 1989, University of WisconsinMadison.

Supported by funds from Norwich Eaton Pharmaceuticals, a Procter & Gamble company. 22.

Invest Radiol 1977; 12:1804.

24. The asterisk indicates a significant change from base line (P<0.017). Bisphosphonates history and experimental basis . Parfitt AM.

Intermittent cyclical therapy with etidronate, whether or not preceded by phosphate administration, resulted in significant increases in the bone mineral density of the spine after 12 months that were sustained for the remainder of the 24-month study period. Calcif Tissue Int 1989; 44:749. Consenting patients were randomised in a central office to either HRT, etidronate, HRT plus etidronate or no treatment.

27. 2009 Feb;54(1):21-5. The addition of phosphate provided no apparent benefit.

Information on the progress of the patients was requested by the co-ordinating office annually for 5 years after entry to the trial. Lateral radiographs of the thoracic and lumbar spine were obtained at entry and after 12 and 24 months. The increases in bone density and reduction in vertebral-fracture rates associated with etidronate treatment are most likely attributable to its antiresorptive activity.

N Engl J Med 1990; 322:8029. ); Kuakini Medical Center, Honolulu (R.D.W., P.R.

None had ever been treated with sodium fluoride, any bisphosphonate, or calcitonin.

The patients were randomly assigned by computer to treatment groups (Table 1) in blocks of four. Fluoride therapy for the vertebral crush fracture syndrome: a status report .

Six of these patients withdrew from the study before beginning the regimen; the results presented are those for the 423 patients who began the study regimen. Because there is an inverse relation between bone mineral density and the risk of fracture,20 21 22 23 the patients were divided into two subgroups on the basis of the relation of their initial Z score for spinal bone mineral density to the calculated 50th percentile, which corresponded to a base-line Z score of 2.67. Diarrhea was reported in 7 to 9 percent of the patients in all groups during the etidronate (or placebo) phase; however, during the phosphate (or placebo) phase, diarrhea occurred in 39 percent of the patients receiving phosphate (groups 2 and 4), as compared with 9 percent of the patients receiving placebo (groups 1 and 3).

There were fewer patients with new vertebral fractures in the subgroups with low bone mineral density that received etidronate (groups 3 and 4) than in the subgroups that did not (groups 1 and 2) (Table 4). that was measured twice yearly at each center to monitor relative accuracy and long-term precision.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

The samples were evaluated qualitatively for evidence of osteomalacia and gross mineralization defects.

. Mean (SE) Changes in Bone Mineral Density of the Spine (as Measured by Dual-Photon Absorptiometry) in Group 1 (Placebo and Placebo; Open Circles), Group 2 (Phosphate and Placebo; Open Squares), Group 3 (Placebo and Etidronate; Solid Circles), and Group 4 (Phosphate and Etidronate; Solid Squares).

Information regarding deaths was obtained from medical records.

No significant intergroup differences were observed. 3). The correlation coefficient of repeated analyses was 0.98 (Genant HK: unpublished data).

.

Serum C-terminal or mid-molecule parathyroid hormone concentrations were measured at entry, at six-month intervals during the study, and before (fasting) and two hours after the ingestion of phosphate or placebo on day 3 of cycles 1 and 8. Am J Epidemiol 1989; 129:100011.

Biochemical variables of interest, with the exception of parathyroid hormone, were analyzed by paired t-tests (intragroup) and one-way analysis of variance (intergroup) at entry and after 24 months. All patients were counseled in ways to include at least 700 mg of calcium in their daily diet and were given 500 mg of calcium to take on the days that they did not take phosphate or etidronate (or the corresponding placebo). Dietary calcium intake at entry was estimated by questionnaire.

5.

Serum parathyroid hormone levels increased significantly after two days of oral phosphate in the groups that received phosphate (49.1 percent in group 2 and 64.0 percent in group 4; P<0.05), with a further rise on day 3 after phosphate administration in cycle 1 (41.8 percent in group 2 and 68.7 percent in group 4; P<0.05). Coherence therapy does not prevent axial bone loss in osteoporotic women: a preliminary comparative study . Blood samples were collected after at least a four-hour fast, before the ingestion of that day's study drug.

Please remove one or more studies before adding more.

. A comparison between groups after 24 months showed no significant differences in basal levels of serum parathyroid hormone, indicating that sustained secondary hyperparathyroidism was not induced by intermittent phosphate administration and that calcium administration did not induce a significant reduction of parathyroid hormone levels (data not shown). For general information, Learn About Clinical Studies.

Patients participating in this randomized, double-blind, placebo-controlled trial were studied at seven centers: Cleveland Clinic Foundation, Cleveland; Emory University School of Medicine, Atlanta; Kuakini Medical Center, Honolulu; Ohio State University, Columbus; University of California, San Francisco; University of Colorado Health Sciences Center, Denver; and University of Washington, Seattle.

Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. J Clin Endocrinol Metab 1989; 68:1509.

Mean (SE) Changes in Bone Mineral Density of the Greater Trochanter (Hatched Bars), Ward's Triangle (Open Bars), and the Femoral Neck (Solid Bars) (as Measured by Dual-Photon Absorptiometry) after 24 Months, in Group 1 (Placebo and Placebo), Group 2 (Phosphate and Placebo), Group 3 (Placebo and Etidronate), and Group 4 (Phosphate and Etidronate). The comparability of the four treatment groups at base line was tested by one-way analysis of variance. Numbers of Patients with New Vertebral Fractures and Rates of New Vertebral Fractures during the 24-Month Study Period in the Subgroups of Patients with Low Bone Mineral Density at Base Line.*.

Lunar DP3 densitometers (Lunar Radiation, Madison, Wis.) were used at five centers; a Norland 2600 densitometer (Norland, Fort Atkinson, Wis.) was used at one center, and a modified Ohio Nuclear Series 84 gamma camera (Ohio Nuclear, Solon, Ohio) at one center. Therapy with etidronate was associated with few side effects. There also were no significant intergroup differences at base line in the bone mineral density of the spine or other characteristics in the subgroups with low bone mineral density (data not shown).

4. J Bone Miner Res 1989; 4:1438. Cyclic therapy of osteoporosis with neutral phosphate and brief, high-dose pulses of etidronate .

Osteoporosis 1987: International Symposium on Osteoporosis, Denmark, September 27October 2, 1987.

The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams.

Rates of New Vertebral Fractures in the Groups That Received Etidronate (Groups 3 and 4) and Those That Did Not (Groups 1 and 2) during the 24-Month Study.

For comparisons of the rates of new vertebral fractures (expressed as the number of fractures per 1000 patient-years), KruskalWallis analysis was used for four-group comparisons, and the Wilcoxon rank-sum test for two-group comparisons. The frequency of nausea was 5 to 6 percent in all groups during both the phosphate (or placebo) phase and the etidronate (or placebo) phase of the treatment regimen.

We are indebted to Ms. P.J. Paired comparisons were performed by the method of linear contrasts. Intermittent Cyclical Etidronate Treatment of Postmenopausal Osteoporosis, Selected Characteristics of the Study Subjects at Entry.*. 7. The responses to treatment with etidronate at other skeletal sites were heterogeneous.

Intermittent cyclical therapy with etidronate should be a welcome addition to the therapeutic options for osteoporosis, restoring bone mass and reducing the risk of vertebral fractures in patients with this debilitating disease. Valuable tools for building a rewarding career in health care. However, our findings are consistent with those reported by Storm et al., who used a similar regimen of intermittent cyclical etidronate.27 It should be noted that oral etidronate is poorly absorbed; because food further decreases its absorption, etidronate must be taken on an empty stomach (one hour before meals or two hours after).28 , 29 Failure to ensure that etidronate is taken in this manner may account for some of the negative results in studies using this drug.15. No osteomalacia was evident in any pretreatment biopsy samples; no mineralization defects (osteomalacia or hyperosteoidosis, for example) were detected in any post-treatment samples. Results of a stimulatory therapy of low bone metabolism in osteoporosis with (138)hPTH and diphosphonate EHDP: protocol of study I, osteoporosis trial Hannover .

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