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PubMed1999

International Consensus Statement on Testing and Reporting of Antineutrophil Cytoplasmic Antibodies (ANCA)

Antineutrophil cytoplasmic antibody (ANCA) tests are used to diagnose and monitor inflammatory activity in the primary systemic small vessel vasculitides. ANCA is best demonstrated in these diseases by using a combination of indirect immunofluorescence (IIF) of normal peripheral blood neutrophils and enzyme-linked immunosorbent assays (ELISAs) that detect ANCA specific for proteinase 3 (PR3) or myeloperoxidase (MPO). For ANCA testing in "new" patients, IIF must be performed on all serum samples. Serum samples containing ANCA, any other cytoplasmic fluorescence, or an antinuclear antibody (ANA) that results in homogeneous or peripheral nuclear fluorescence then should be tested in ELISAs for PR3-ANCA and MPO-ANCA. Optimally, ELISAs for PR3-ANCA and MPO-ANCA should be performed on all serum samples. Inclusion of the most recent positive sample in the IIF or ELISA may help demonstrate a change in antibody level. Reports should use recommended terms. Any report of positive neutrophil fluorescence issued before the ELISA results are available should indicate that positive fluorescence alone is not specific for the diagnosis of Wegener granulomatosis or microscopic polyangiitis and that decisions about treatment should not be based solely on the ANCA results.

Antibodies, Antineutrophil Cytoplasmic↗

PubMed2002

Economic evaluation of vaccination programmes: a consensus statement focusing on viral hepatitis.

The methods that have been used to estimate the clinical and economic impact of vaccination programmes are not always uniform, which makes it difficult to compare results between economic analyses. Furthermore, the relative efficiency of vaccination programmes can be sensitive to some of the more controversial aspects covered by general guidelines for the economic evaluation of healthcare programmes, such as discounting of health gains and the treatment of future unrelated costs. In view of this, we interpret some aspects of these guidelines with respect to vaccination and offer recommendations for future analyses. These recommendations include more transparency and validation, more careful choice of models (tailored to the infection and the target groups), more extensive sensitivity analyses, and for all economic evaluations (also nonvaccine related) to be in better accordance with general guidelines. We use these recommendations to interpret the evidence provided by economic evaluation applied to viral hepatitis vaccination. We conclude that universal hepatitis B vaccination (of neonates, infants or adolescents) seems to be the most optimal strategy worldwide, except in the few areas of very low endemicity, where the evidence to enable a choice between selective and universal vaccination remains inconclusive. While targeted hepatitis A vaccination seems economically unattractive, universal hepatitis A vaccination strategies have not yet been sufficiently investigated to draw general conclusions.

Adolescent↗

PubMed2002

A systematic approach to erectile dysfunction in the cardiovascular patient: a Consensus Statement--update 2002.

Sexual activity is no more stressful to the heart when compared with a number of other natural daily activities, e.g. walking one mile on the level in 20 minutes. The cardiac risk of sexual activity in patients diagnosed with cardiovascular disease is minimal in properly assessed and advised patients. Erectile dysfunction (ED) is extremely common, affecting over half of men aged 40-70 years, and increases in frequency with age. ED and cardiovascular disease share many of the same risk factors and commonly coexist. ED in the otherwise asymptomatic man may be a marker for underlying coronary artery disease. ED in the diagnosed cardiovascular patient should be identified by routine questioning in general practice. Modern therapies can restore a sexual relationship in the majority of patients with ED and can lead to a substantial improvement in quality of life. The majority of patients assessed to be at low or intermediate cardiac risk, as defined later in this paper, can be effectively managed in primary care. Primary care treatment for ED in patients defined as high risk can be initiated following a specialist opinion and/or confirmation that the patient's cardiovascular condition is stabilised. There is no evidence that currently licensed treatments for ED add to the overall cardiovascular risk in patients with or without diagnosed cardiovascular disease. If one form of therapy is not effective, follow-up will identify the need for alternative approaches. The pro-active management of ED in the cardiovascular patient provides an ideal and effective opportunity to address other cardiovascular risk factors and improve treatment outcomes.

Activities of Daily Living↗

PubMed2006

Mayo clinic consensus statement for the use of bisphosphonates in multiple myeloma.

Bisphosphonates are effective in the prevention and treatment of bone disease in multiple myeloma (MM). Osteonecrosis of the jaw is Increasingly recognized as a serious complication of long-term bisphosphonate therapy. Issues such as the choice of bisphosphonate and duration of therapy have become the subject of intense debate given patient safety concerns. We reviewed available data concerning the use of bisphosphonates in MM. Guidelines for the use of bisphosphonates in MM were developed by a multidisciplinary panel consisting of hematologists, dental specialists, and nurses specializing in the treatment of MM. We conclude that intravenous pamidronate and intravenous zoledronic acid are equally effective and superior to placebo in reducing skeletal complications. Pamidronate is favored over zoledronic acid until more data are available on the risk of complications (osteonecrosis of the jaw). We recommend discontinuing bisphosphonates after 2 years of therapy for patients who achieve complete response and/or plateau phase. For patients whose disease is active, who have not achieved a response, or who have threatening bone disease beyond 2 years, therapy can be decreased to every 3 months. These guidelines were developed in the Interest of patient safety and will be reexamined as new data emerge regarding risks and benefits.

Bone Density Conservation Agents↗

PubMed2006

Protecting participants in family medicine research: a consensus statement on improving research integrity and participants' safety in educational research, community-based participatory research, and practice network research.

Recent events that include the deaths of research subjects and the falsification of data have drawn greater scrutiny on assuring research data integrity and protecting participants. Several organizations have created guidelines to help guide researchers working in the area of clinical trials and ensure that their research is safe and valid. However, family medicine researchers often engage in research that differs from a typical clinical trial. Investigators working in the areas of educational research, community-based participatory research, and practice-based network research would benefit from similar recommendations to guide their own research. With funding from the US Office of Research Integrity and the Association of American Medical Colleges, we convened a panel to review issues of data integrity and participant protection in educational research, community-based participatory research, and research conducted by practice-based networks. The panel generated 11 recommendations for researchers working in these areas. Three key recommendations include the need for (1) all educational research to undergo review and approval by an institutional review board (IRB), (2) community-based participatory research to be approved not just by an IRB but also by appropriate community representatives, and (3) practice-based researchers to undertake only valid and meaningful studies that can be reviewed by a central IRB, rather than separate IRBs for each participating practice.

Biomedical Research↗

PubMed2004

Defining competencies in psychology supervision: a consensus statement.

Supervision is a domain of professional practice conducted by many psychologists but for which formal training and standards have been largely neglected. In this article, supervision is proposed as a core competency area in psychology for which a number of elements reflecting specific knowledge, skills, and values must be addressed to ensure adequate training and professional development of the trainee. Supra-ordinate factors of supervision viewed as permeating all aspects of professional development are proposed. These include the perspective that professional development is a lifelong, cumulative process requiring attention to diversity in all its forms, as well as legal and ethical issues, personal and professional factors, and self- and peer-assessment. A competencies framework is presented with particular elements representing knowledge (e.g., about psychotherapy, research, etc.), skills (including supervising modalities, relationship skills, etc.), values (e.g., responsibility for the clients and supervisee rests with supervisor, etc.), and meta-knowledge. Social contextual factors and issues of education and training, assessment, and future directions also are addressed, with specific elements listed. Suggestions for future work in this area are addressed, including the need to refine further and operationalize competences, develop clear expectations for accreditation and licensure regarding supervision competencies, and expand the description of developmental levels of supervisors from minimal to optimal competence. This is one of a series of articles published together in this issue of the Journal of Clinical Psychology. Several other articles that resulted from the Competencies Conference: Future Directions in Education and Credentialing in Professional Psychology will appear in Professional Psychology: Research and Practice and The Counseling Psychologist.

Clinical Competence↗

PubMed1990

Consensus statement on the investigation and management of testicular seminoma 1989.

In the past 10 years, many developments have allowed us to understand more fully the natural history and routes of spread of testicular seminoma. The development of radiological tests such as CT scanning has allowed us to better assess the extent of disease. The availability of serum tumor markers AFP and beta HCG has facilitated the recognition of the presence of occult non-seminomatous elements. These developments plus the knowledge that seminoma is sensitive to cisplatin containing chemotherapy and that it is exquisitely sensitivity to radiation therapy resulted in further improvement in therapy. Overall we now expect 97 to 98% of patients will be cured of their disease. Currently, a number of issues in the management of seminoma remain controversial. These controversies however impact on very small proportion of patients with seminoma. Between 5 and 10% of patients have stage IID, III, or IV disease and 10 to 20% of these patients ie: 1 or 2% of the total population actually die from testicular seminoma. Thus it is for patients with advanced disease that we seek to define the nature of optimal chemotherapy, that is the most effective yet least toxic regimen. For those 1 or 2% of patients dying of seminoma we seek to identify prognostic factors to identify these patients and better treatments for them. Refinements in the application of radiation therapy for early stage disease, should allow some reduction in the morbidity of radiation without compromising control rates. Testicular seminoma its investigation and management, serves as a model for understanding other malignant processes and for orderly ways in which to refine the therapeutic ratio in the management of disease.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2000

Prognostic factors in prostate cancer. College of American Pathologists Consensus Statement 1999.

BACKGROUND: Under the auspices of the College of American Pathologists, a multidisciplinary group of clinicians, pathologists, and statisticians considered prognostic and predictive factors in prostate cancer and stratified them into categories reflecting the strength of published evidence and taking into account the expert opinions of the Prostate Working Group members. MATERIALS AND METHODS: Factors were ranked according to the previous College of American Pathologists categorical rankings: category I, factors proven to be of prognostic importance and useful in clinical patient management; category II, factors that have been extensively studied biologically and clinically but whose importance remains to be validated in statistically robust studies; and category III, all other factors not sufficiently studied to demonstrate their prognostic value. Factors in categories I and II were considered with respect to variations in methods of analysis, interpretation of findings, reporting of data, and statistical evaluation. For each factor, detailed recommendations for improvement were made. Recommendations were based on the following aims: (1) increasing uniformity and completeness of pathologic evaluation of tumor specimens, (2) enhancing the quality of data collected pertaining to existing prognostic factors, and (3) improving patient care. RESULTS AND CONCLUSIONS: Factors ranked in category I included preoperative serum prostate-specific antigen level, TNM stage grouping, histologic grade as Gleason score, and surgical margin status. Category II factors included tumor volume, histologic type, and DNA ploidy. Factors in category III included perineural invasion, neuroendocrine differentiation, microvessel density, nuclear roundness, chromatin texture, other karyometric factors, proliferation markers, prostate-specific antigen derivatives, and other factors (oncogenes, tumor suppressor genes, apoptosis genes, etc).

Biomarkers, Tumor↗

PubMed1996

Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 6. Use of bisphosphonates in the treatment of osteoporosis.

OBJECTIVE: To describe the mechanisms of action of bisphosphonates in the treatment of osteoporosis and compare bisphosphonate therapy with other treatments. OPTIONS: The bisphosphonates, etidronate, alendronate, clodronate, pamidronate, tiludronate, ibandronate and risedronate; combined bisphosphonates and estrogen; combined bisphosphonates and calcium supplements. OUTCOMES: Fracture and loss of bone mineral density in osteoporosis; increased bone mass, prevention of fractures and improved quality of life associated with bisphosphonate treatment. EVIDENCE: Relevant clinical studies and reports were examined with emphasis on recent controlled trials. The availability of treatment products in Canada was also considered. VALUES: Reducing fractures, increasing bone mineral density and minimizing side effects of treatment were given a high value. BENEFITS, HARMS AND COSTS: Treatment with bisphosphonates may be an acceptable alternative to ovarian hormone therapy in increasing bone mass and decreasing fractures associated with osteoporosis. Compared with estrogens, bisphosphonates are bone-tissue specific, have equal or greater antiresorptive effect and have few side effects and no known risk for carcinogenesis. They also hold promise in treating male osteoporosis and steroid-induced bone loss. Prolonged, continuous treatment with etidronate may lead to impaired calcification of newly formed bone; therefore, etidronate is administered cyclically. This risk is not present in newer generations of bisphosphonates. RECOMMENDATIONS: Bisphosphonate therapies may be considered as an alternative to ovarian hormone therapy in postmenopausal osteopenic or osteoporotic women who cannot or will not tolerate ovarian hormone therapy. They should also be considered in treating male osteoporosis and steroid-induced bone loss. Combination therapy with estrogen may be effective, although more research is needed. Combination therapy with calcium supplements is recommended. Bisphosphonate therapies should be restricted to postmenopausal patients with osteopenia or established osteoporosis and are not yet recommended for younger perimenopausal women as prophylaxis.

Aged↗

PubMed1996

Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 9. Calcitonin in the treatment of osteoporosis.

OBJECTIVE: To describe potential therapeutic uses of calcitonin in the prevention and treatment of osteoporosis. OPTIONS: Parenterally and intranasally administered calcitonin (eel, salmon or human). OUTCOMES: Fracture, fracture pain and loss of bone mineral density in osteoporosis; increased bone mass, prevention of fractures, reduction of pain and improved quality of life associated with calcitonin treatment. EVIDENCE: Relevant clinical studies and reports were examined, with an emphasis on recent randomized, placebo-controlled trials. In vitro and in vivo studies of osteoclast activity were also considered. VALUES: Reducing fractures and fracture pain, increasing bone mineral density and minimizing side effects of treatment were given a high value. BENEFITS, HARMS AND COSTS: Calcitonin reduces acute pain associated with osteoporotic fractures and has been found useful in treating chronic back pain following vertebral fractures in spinal osteoporosis. It can prevent bone loss and may be effective in preventing fractures. Side effects are dose related and generally mild; they include gastrointestinal, vascular and dermatologic conditions that can be treated symptomatically or by varying the dosage. Side effects are much rarer with nasal administration than with injection. True allergic reactions are rare. RECOMMENDATIONS: Calcitonin in both intramuscular and intranasal forms can reduce the pain of acute osteoporotic vertebral fractures and may be effective in treating that associated with chronic vertebral osteoporotic fractures. Calcitonin may also prevent postmenopausal bone loss and increase bone density in those with established osteoporosis. Current evidence for long-term prevention of fractures is limited and does not support the use of calcitonin as a first-line treatment for established osteoporosis. Most side effects can be avoided with nasal administration. Further trials are needed to assess fracture prevention and effective dose ranges for treating pain and increasing bone mineral density and to determine the long-term efficacy of calcitonin in secondary osteoporosis, in premenopausal women, in men and in elderly people.

Aged↗

PubMed2005

Consensus statement. Workshop on therapeutic resistance in breast cancer: impact of growth factor signalling pathways and implications for future treatment.

Anti-hormones (notably tamoxifen), chemotherapy and modern radiotherapeutic approaches are invaluable in the management of breast cancer, and collectively have contributed substantially to the improved survival in this disease. Moreover, there is promise that these successes will continue with the emergence of other endocrine agents (for example, aromatase inhibitors and pure anti-oestrogens). However, de novo and acquired resistance comprises a significant problem with all treatment approaches examined to date. This Workshop aimed to evaluate the contribution made by growth factor signalling pathways in the various resistant states, primarily focusing on resistance to anti-hormonal strategies and spanning experimental models and, where possible, clinical breast cancer data. The successes and limitations of therapeutic targeting of these pathways with various signal transduction inhibitors (STIs) were evaluated in model systems and from emerging clinical trials (including epidermal growth factor receptor inhibitors such as gefitinib). It was concluded that growth factor signalling is an important contributor in the development of endocrine resistance in breast cancer and that use of STIs provides a promising therapeutic strategy for this disease. However, the cancer cell is clearly able to harness alternative growth factor signalling pathways for growth and cell survival in the presence of STI monotherapy and, as a consequence, the efficacy of STIs is likely to be limited by the acquisition of resistance. A number of strategies were proposed from studies in model systems that appeared to enhance anti-tumour actions of existing STI monotherapy, notably including combination therapies targeting multiple pathways. With the increased availability of diverse STIs and improved drug delivery, there is much hope that the more complex therapeutic strategies proposed may ultimately be achievable in clinical practice.

Breast Neoplasms↗

PubMed2000

Consensus statement: anemia in HIV infection--current trends, treatment options, and practice strategies. Anemia in HIV Working Group.

BACKGROUND: Despite important advances in antiretroviral therapy, anemia remains a problem in many HIV-infected patients. Although the incidence of anemia in these patients has decreased, its prevalence appears to have stabilized or decreased only slightly. Anemia has a deleterious effect on both functional capacity and quality of life, and has been associated with shortened survival. OBJECTIVE: The Anemia in HIV Working Group, an expert panel of physicians and researchers involved in the care of HIV-infected patients, met to determine the impact of anemia in this patient population; to develop practice strategies for the clinician treating HIV-infected patients with anemia; and to identify future research directions. METHODS: The proposed practice strategies are based on results of the available clinical trials (as identified through a MEDLINE search), a review of the literature, and the clinical experience and expert opinion of the panel. The present report is based on meetings held in February and June of 1998; as further experience with various treatment options accumulates and the impact of highly active antiretroviral therapy becomes clearer, the panel will reconvene to develop evidence-based guidelines. RESULTS: The working group considers HIV-associated anemia to be an important contributor to the morbidity and mortality of this infection. Recent reports indicate that recovery from anemia is associated with improved quality of life and survival. CONCLUSIONS: As HIV-infected persons live longer, maintaining quality of life becomes an increasingly important goal of treatment. When planning treatment strategies, clinicians should consider the quality-of-life decrement caused by anemia. Transfusions should be used when rapid recovery is required, and underlying conditions causing anemia should be treated, if possible. Recombinant human erythropoietin (rHuEPO) therapy is appropriate in certain HIV-infected persons and should be considered to maintain hemoglobin concentrations. The target hemoglobin level is 12 g/dL for men and 11 g/dL for women. Weekly rHuEPO dosing is suggested, initiated at 40,000 U, as has been established in patients with cancer.

Anemia↗

PubMed1996

Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 7. Fluoride therapy for osteoporosis.

OBJECTIVE: To present the latest findings on the use of fluoride in the treatment of osteoporosis. OPTIONS: Plain sodium fluoride (NaF), enteric-coated sodium fluoride (EC-NaF), sodium monofluorophosphate (Na2FPO4), slow-release sodium fluoride (SR-NaF); fluoride with a calcium supplement. OUTCOMES: Fracture and loss of bone mineral density in osteoporosis; increased bone mass, prevention of fractures and improved quality of life associated with treatment. EVIDENCE: Relevant clinical studies and reports were examined, with an emphasis on recent prospective, randomized, controlled trials. Clinical practices in European countries were also considered. VALUES: Reducing fractures, increasing bone mineral density and minimizing side effects of treatment were given a high value. BENEFITS, HARMS AND COSTS: NaF therapy stimulates bone formation and may be effective in preventing osteoporotic fractures. It may be an acceptable alternative treatment to estrogen or bisphosphonate therapy and useful in premenopausal and corticosteroid-induced osteoporosis and in some patients with mild osteogenesis imperfecta. Toxic effects are dependent on formulation and dosage. They include a range of gastrointestinal and musculoskeletal conditions. EC-NaF is associated with less toxicity than plain NaF; its gastrointestinal toxicity is negligible. Na2FPO4 has no gastrointestinal toxicity, but can give rise to skeletal toxicity. SR-NaF appears to have no side effects when given intermittently. Carcinogenicity has not been found in vivo with fluoride therapy, despite in vitro results. RECOMMENDATIONS: New data indicate that fluoride therapy should be re-evaluated as a potentially effective treatment of osteoporosis with minimal side effects. More studies are needed of slow-release fluoride formulations, intermittent treatment schedules and calcium supplementation of fluoride. Studies should be undertaken to see if it is advantageous to initiate treatment with antiresorptive agents before or in combination with fluoride. Conclusive data have not been presented regarding the benefit of any specific type of calcium supplement. Further studies on the basic mechanism of action of fluoride on the skeleton are necessary to evaluate fluoride's potential to stimulate bone formation therapeutically.

Aged↗

PubMed1996

Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 3. Effects of ovarian hormone therapy on skeletal and extraskeletal tissues in women.

OBJECTIVE: To present recent evidence on the use of ovarian hormone therapy (OHT) for osteoporosis and outline safe and effective regimens. OPTIONS: Estrogen alone, estrogen and progestins, progestins alone; various treatment regimens. OUTCOMES: Fracture and loss of bone mineral density in osteoporosis; increased bone mass, prevention of fractures and improved quality of life associated with OHT. EVIDENCE: Relevant clinical studies and reports, including the Nurses' Health Study and the Post-menopausal Estrogen/Progestin Interventions (PEPI) Trial, were studied with emphasis on recent prospective, randomized, controlled trials. Current clinical practice was determined by survey. VALUES: Reducing fractures, increasing bone mineral density and minimizing side effects of treatment were given a high value. BENEFITS, HARMS AND COSTS: Proper management of osteoporosis minimizes injury and disability, improves quality of life and reduces the personal and social costs associated with the condition. OHT is the front-line pharmaceutical therapy for prevention and treatment of osteoporosis in post-menopausal women. In those who are able and willing to comply with therapy, OHT prevents bone loss and fractures. Hormone therapy may also decrease risk of coronary artery disease. Cyclic progestin protects against endometrial cancer in patients receiving estrogen. Potential harms include breast cancer and endometrial cancer related to dosage and duration of therapy. Mastalgia and especially resumption of menstrual bleeding affect compliance. RECOMMENDATIONS: Use of OHT should be considered as early as possible in the perimenopausal period for women at increased risk of osteoporosis. Guidelines are provided for assessment of osteoporosis risk. Physicians and their patients should take into account the absolute and relative contraindications to OHT. Women with a uterus should be given estrogen in combination with a progestin. Ideally, therapy would be continued for a minimum of 10 years beyond menopause for maximum bone protection. Women using OHT should be carefully monitored and evaluated for possible adverse events. This should include regular screening mammography, breast examination and, for some, endometrial surveillance. Specific dosages and treatment regimens are outlined.

Adult↗

PubMed2000

Obstructive sleep apnea, polysomnography, and split-night studies: consensus statement of the Connecticut Thoracic Society and the Connecticut Neurological Society.

Obstructive sleep apnea is a state-dependent syndrome. It is characterized by repeated collapse of the upper airway as the result of the loss of waking neuromuscular drive as the brain changes from wakefulness to sleep. This produces a state-dependent decrease in muscle tone, which, together with other predisposing factors such as obesity and anatomical narrowing of the upper airway, results in the spectrum of sleep disordered breathing. Sleep-disordered breathing describes the continuum from simple snoring (pharyngeal vibration), to flow limitation (hypopnea), to complete cessation of breathing (apnea). Obstructive sleep apnea (OSA) is the common description of what is now appreciated as the sleep apnea/hypopnea syndrome. The cardinal symptoms are snoring, observed apneas, and excessive daytime sleepiness. The immediate physical consequences are hypoxia, repeated sympathetic discharges, increased cardiac load, and repeated brain arousals. The repetitive arousals are required to restore airway patency, resulting in severely fragmented sleep and consequent sleep deprivation. The syndrome, untreated, produces significant cognitive and cardiorespiratory morbidity, and potential mortality. Compared to matched controls, patients with undiagnosed sleep apnea use twice the health resources and spend double the health-care dollars in the 10 years prior to diagnosis. Both trends are reversed by successful treatment. It is by definition a sleep-related illness and can be observed and evaluated only when the patient is asleep. Polysomnography is the laboratory procedure to study sleep and its protean dysfunctions. Multiple physiologic parameters are required to document the various types of sleep disorders as well as to establish the origin of pathologic sleep fragmentation. Complete polysomnography includes (but is not limited to) electroencephalogram (EEG), electrooculogram ((EOG), electromyogram (EMG), electrocardiogram (ECG), respiratory effort, air flow, and oxygen saturation. Treatment options for obstructive sleep apnea include continuous positive airway pressure (CPAP), oral appliances, uvulopalatal and/or maxillomandibular surgery, positional control, and weight loss. The efficacy of each depends on the individual anatomy and the severity of the sleep-disordered breathing. CPAP is accepted as the most reliable treatment regardless of anatomy and severity. It is currently the only treatment modality which can be titrated during sleep and requires simultaneous polysomnography.

Connecticut↗

PubMed1996

Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 4. Calcium nutrition and osteoporosis.

OBJECTIVE: To recommend appropriate levels of calcium intake in light of the most recent studies. OPTIONS: Dietary calcium intake, calcium supplementation, calcium and vitamin D supplementation; ovarian hormone therapy in postmenopausal women. OUTCOMES: Fracture and loss of bone mineral density in osteoporosis; increased bone mass, prevention of fractures and improved quality of life associated with osteoporosis prevention. EVIDENCE: Relevant clinical studies and reports were examined, in particular those published since the 1988 Osteoporosis Society of Canada position paper on calcium nutrition. Only studies in humans were considered, including controlled, randomized trials and prospective studies, using bone mass and fractures as end-points. Studies in early and later phases of skeletal growth were noted. The analysis was designed to eliminate menopause as a confounding variable. VALUES: Preventing osteoporosis and maximizing quality of life were given a high value. BENEFITS, HARMS AND COSTS: Adequate calcium nutrition increases bone mineral density during skeletal growth and prevents bone loss and osteoporotic fractures in the elderly. Risks associated with high dietary calcium intake are low, and a recent study extends this conclusion to the risk of kidney stones. Lactase-deficient patients may substitute yogurt and lactase-treated milk for cow's milk. True milk allergy is probably rare; its promotion of diabetes mellitus in susceptible people is being studied. RECOMMENDATIONS: Current recommended intakes of calcium are too low. Revised intake guidelines designed to reduce bone loss and protect against osteoporotic fractures are suggested. Canadians should attempt to meet their calcium requirements principally through food sources. Pharmaceutical calcium supplements and a dietician's advice should be considered where dietary preferences or lactase deficiency restrict consumption of dairy foods. Further research is necessary before recommending the general use of calcium supplements by adolescents. Calcium supplementation cannot substitute for hormone therapy in the prevention of postmenopausal bone loss and fractures. Adequate amounts of vitamin D are necessary for optimal calcium absorption and bone health. Elderly people and those who use heavy sun screens should have a dietary intake of 400 to 800 IU of vitamin D per day.

Aged↗

PubMed1996

Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 2. The use of bone density measurement in the diagnosis and management of osteoporosis.

OBJECTIVE: To determine the best method of diagnosing osteoporosis and determining fracture risk and to promote standards in the use of bone densitometry and the reporting of results. OPTIONS: Methods of bone mineral density measurement: dual-energy x-ray absorptiometry (DXA), radiographic absorptiometry, single-photon absorptiometry, dual-photon absorptiometry, quantitative computed tomography, quantitative ultrasound, neutron activation analysis. The options of using bone densitometry in individual patient management and as a mass screening tool are also considered. OUTCOMES: Appropriate use of densitometry to promote accurate diagnosis and assessment of fracture risk and timely, appropriate treatment. EVIDENCE: Relevant clinical studies and reports were examined. Clinical practice in Canada was also considered. VALUES: Accurate assessment of osteoporotic fracture risk and diagnosis of osteoporosis and assuring low exposure to medical radiation were given a high value. BENEFITS, HARMS AND COSTS: Early diagnosis through bone density measurement allows proper management of osteoporosis to minimize injury and disability, improve quality of life and reduce the personal and social costs associated with the condition. Potential harms include radiation exposure and cost. The harms and costs of appropriate use of DXA are minimal compared with the harms and costs associated with osteoporosis. RECOMMENDATIONS: Bone mineral density should be measured only to assist in making a clinical management choice. DXA is the best method of measuring bone density and, thus, the best available indicator of osteoporotic fracture risk. Plain radiographs may supplement DXA if there is a specific reason for their use. Measurement of the lumbar spine and femoral neck is standard, but a different site or a single measurement is recommended in specific cases. Unless accelerated bone loss is suspected, DXA should be repeated every 2 to 4 years for patients receiving ovarian hormone therapy and 1 to 2 years for patients undergoing bisphosphonate therapy. Measurements and reporting of results must be standardized. Reports should refer to the World Health Organization's recommended definitions of osteopenia and osteoporosis and provide actual measurement and its relation to peak bone mass.

Aged↗

PubMed1996

Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 8. Vitamin D metabolites and analogs in the treatment of osteoporosis.

OBJECTIVE: To review recent findings on the skeletal actions of vitamin D and to examine results of the latest clinical trials of vitamin D in the treatment of osteoporosis. OPTIONS: The vitamin D analog 1-alpha hydroxycholecalciferol (1 alpha-OH-D3); the vitamin D metabolite calcitriol. OUTCOMES: Fracture and loss of bone mineral density in osteoporosis; increased bone mass, prevention of fractures and improved quality of life associated with vitamin D therapies. EVIDENCE: Relevant laboratory and clinical studies and reports were examined. Greatest reliance was placed on recent large-scale, randomized, controlled trials; others were noted and their methods critiqued. Clinical practice in Japan was also considered. VALUES: Reducing fractures, increasing bone mineral density and minimizing side effects of treatment were given a high value. BENEFITS, HARMS AND COSTS: Vitamin D maintains the dynamic nature of bone and so presumably helps to keep it healthy. Calcitriol and 1 alpha-OH-D3 may be effective in increasing bone mass and preventing fractures in osteoporosis. Calcitriol may be an alternative treatment in the prevention and management of corticosteroid-induced osteoporosis. Possible side effects of vitamin D analogs and metabolites are hypercalcemia, hypercalciuria, renal calcification and renal stones. RECOMMENDATIONS: The use of 1 alpha-OH-D3 for the treatment of osteoporosis in Canada cannot be supported without larger and longer randomized, controlled clinical trials. Calcitriol appears to prevent vertebral fractures in patients with osteoporosis. More information is needed on its mechanism of action and efficacy in preventing hip fractures. Future studies should focus on comparisons with other effective therapies and on determining whether its effect on fractures is greater than that achieved through improved vitamin D nutrition. Patients taking calcitriol at dose levels required for antifracture effects should be monitored for serum and urine calcium response to the drug. Calcitriol should not be given to patients whose calcium intake is at current generally recommended levels. At present, prescription of calcitriol for the treatment of osteoporosis should be reserved for physicians with a special interest in the treatment of metabolic bone disease.

Aged↗