Osteoporosis: Lewiecki EM

Lewiecki EM, Baim S, Binkley N, Bilezikian JP, Kendler DL, Hans DB, Silverman S, Anonymous00044. · New Mexico Clinical Research and Osteoporosis Center, Albuquerque, NM 87106, USA. · South Med J. · Pubmed #18580720 No free full text.

Abstract: The International Society for Clinical Densitometry (ISCD) periodically holds Position Development Conferences (PDCs) for the purpose of establishing standards and guidelines for the assessment of skeletal health -- the nomenclature, indications, acquisition, analysis, quality control, interpretation, and reporting of bone density tests. Topics are selected for consideration according to criteria that include clinical relevancy, uncertainty in the application of medical evidence to clinical practice, and the likelihood of the expert panel achieving agreement. The most recent Adult PDC was held July 20 to 22, 2007, in Lansdowne, Virginia. Topics included technical and clinical issues relevant to dual-energy x-ray absorptiometry (DXA), vertebral fracture assessment, and bone densitometry technologies other than central DXA. This report describes the methodology and presents the results of this PDC. The first ISCD Pediatric PDC was held June 20 to 21, 2007 in Montreal, Quebec, Canada, and is reported separately.

Watts NB, Lewiecki EM, Miller PD, Baim S. · No affiliation provided · J Clin Densitom. · Pubmed #18562228 No free full text.

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Hans DB, Shepherd JA, Schwartz EN, Reid DM, Blake GM, Fordham JN, Fuerst T, Hadji P, Itabashi A, Krieg MA, Lewiecki EM. · Geneva University Hospital, Geneva, Switzerland. <> · J Clin Densitom. · Pubmed #18442759 No free full text.

Abstract: Peripheral assessment of bone density using photon absorptiometry techniques has been available for over 40 yr. The initial use of radio-isotopes as the photon source has been replaced by the use of X-ray technology. A wide variety of models of single- or dual-energy X-ray measurement tools have been made available for purchase, although not all are still commercially available. The Official Positions of the International Society for Clinical Densitometry (ISCD) have been developed following a systematic review of the literature by an ISCD task force and a subsequent Position Development Conference. These cover the technological diversity among peripheral dual-energy X-ray absorptiometry (pDXA) devices; define whether pDXA can be used for fracture risk assessment and/or to diagnose osteoporosis; examine whether pDXA can be used to initiate treatment and/or monitor treatment; provide recommendations for pDXA reporting; and review quality assurance and quality control necessary for effective use of pDXA.

Krieg MA, Barkmann R, Gonnelli S, Stewart A, Bauer DC, Del Rio Barquero L, Kaufman JJ, Lorenc R, Miller PD, Olszynski WP, Poiana C, Schott AM, Lewiecki EM, Hans D. · Lausanne University Hospital, Lausanne, Switzerland. <> · J Clin Densitom. · Pubmed #18442758 No free full text.

Abstract: Dual-energy X-ray absorptiometry (DXA) is commonly used in the care of patients for diagnostic classification of osteoporosis, low bone mass (osteopenia), or normal bone density; assessment of fracture risk; and monitoring changes in bone density over time. The development of other technologies for the evaluation of skeletal health has been associated with uncertainties regarding their applications in clinical practice. Quantitative ultrasound (QUS), a technology for measuring properties of bone at peripheral skeletal sites, is more portable and less expensive than DXA, without the use of ionizing radiation. The proliferation of QUS devices that are technologically diverse, measuring and reporting variable bone parameters in different ways, examining different skeletal sites, and having differing levels of validating data for association with DXA-measured bone density and fracture risk, has created many challenges in applying QUS for use in clinical practice. The International Society for Clinical Densitometry (ISCD) 2007 Position Development Conference (PDC) addressed clinical applications of QUS for fracture risk assessment, diagnosis of osteoporosis, treatment initiation, monitoring of treatment, and quality assurance/quality control. The ISCD Official Positions on QUS resulting from this PDC, the rationale for their establishment, and recommendations for further study are presented here.

Engelke K, Adams JE, Armbrecht G, Augat P, Bogado CE, Bouxsein ML, Felsenberg D, Ito M, Prevrhal S, Hans DB, Lewiecki EM. · Institute of Medical Physics, University of Erlangen, Germany; Synarc, Hamburg, Germany. <> · J Clin Densitom. · Pubmed #18442757 No free full text.

Abstract: The International Society for Clinical Densitometry (ISCD) has developed Official Positions for the clinical use of dual-energy X-ray absorptiometry (DXA) and non-DXA technologies. While only DXA can be used for diagnostic classification according to criteria established by the World Health Organization, DXA and some other technologies may predict fracture risk and be used to monitor skeletal changes over time. ISCD task forces reviewed the evidence for clinical applications of non-DXA techniques and presented reports with recommendations at the 2007 ISCD Position Development Conference. Here we present the ISCD Official Positions for quantitative computed tomography (QCT) and peripheral QCT (pQCT), with supporting medical evidence, rationale, controversy, and suggestions for further study. QCT is available for bone mineral density measurements at the spine, hip, forearm, and tibia. The ISCD Official Positions presented here focus on QCT of the spine and pQCT of the forearm. Measurements at the hip may have clinical relevance, as this is an important fracture site; however, due to limited medical evidence, definitive advice on its use in clinical practice cannot be provided until more data emerge.

Khan AA, Hanley DA, Bilezikian JP, Binkley N, Brown JP, Hodsman AB, Josse RG, Kendler DL, Lewiecki EM, Miller PD, Olszynski WP, Petak SM, Syed ZA, Theriault D, Watts NB, Anonymous00369. · Division of Endocrinology, McMaster University, Hamilton, Ontario, Canada, and Hanover General Hospital, PA, USA. · J Clin Densitom. · Pubmed #16731431 No free full text.

Abstract: This document addresses skeletal health assessment in individuals with secondary causes of osteoporosis. Recommendations are based on consensus of the Canadian Panel of the International Society for Clinical Densitometry and invited international experts. Bone mineral density (BMD) testing in these populations is performed in conjunction with careful evaluation of the disease state contributing to bone loss and increased fragility fracture risk, as well as assessment of other contributing risk factors for fracture. The presence of secondary causes of bone loss may further increase the risk of fracture independently of BMD and may necessitate earlier pharmacologic intervention. Dual-energy X-ray absorptiometry is indicated in the initial workup of secondary causes of osteoporosis. The BMD fracture risk relationship is not known for individuals with chronic renal failure (CRF). The BMD testing in this population may be normal in the presence of skeletal fragility, and quantitative bone histomorphometry is better at evaluating skeletal status than BMD in CRF. Dual-energy X-ray absorptiometry is a valuable tool in assessing skeletal health in individuals with secondary causes of osteoporosis.

Binkley N, Bilezikian JP, Kendler DL, Leib ES, Lewiecki EM, Petak SM, Anonymous00364. · University of Wisconsin, Madison, WI, USA. · J Clin Densitom. · Pubmed #16731426 No free full text.

Abstract: The International Society for Clinical Densitometry (ISCD) convenes a Position Development Conference (PDC) every two years for the purpose of making recommendations on clinically relevant issues in bone densitometry. Topics for consideration are developed by the ISCD Scientific Advisory Committee and the PDC Steering Committee. Clinically relevant questions related to each topic area are assigned to subcommittees for a comprehensive medical literature review and presentation of a report to an international panel of experts. The expert panel includes representatives of the American Society for Bone and Mineral Research (ASBMR) and the International Osteoporosis Foundation (IOF). The recommendations of the PDC expert panel are evaluated by the ISCD Board of Directors, and those that are approved become Official Positions of the ISCD. The Official Positions have subsequently been endorsed by the ASBMR and IOF. The most recent PDC was held July 15-17, 2005, in Vancouver, BC, Canada. Topics considered included technical standardization, vertebral fracture assessment, and application of the 1994 World Health Organization (WHO) criteria to various skeletal sites and to populations other than postmenopausal white women. This report describes the methodology of the 2005 PDC and presents a summary of all ISCD Official Positions.

Lewiecki EM, Watts NB, McClung MR, Petak SM, Bachrach LK, Shepherd JA, Downs RW, Anonymous00133. · New Mexico Clinical Research and Osteoporosis Center, Albuquerque, New Mexico 87106, USA. · J Clin Endocrinol Metab. · Pubmed #15292281 links to  free full text

Abstract: The International Society for Clinical Densitometry (ISCD) periodically holds Position Development Conferences for the purpose of establishing standards and guidelines for indications, acquisition, and interpretation of bone density tests. Topics are selected for consideration by the ISCD Scientific Advisory Committee, reviewed by scientific working groups, and presented to an international panel of experts. Topic categories addressed to date include indications for bone density testing, selection of reference databases for T-scores and Z-scores, clinical applications for central and peripheral bone densitometry, serial bone density testing, instrument precision assessment, phantom scanning and calibration testing, requirements for a bone density report, nomenclature, and diagnosis of osteoporosis in postmenopausal women, premenopausal women, men, and children. After an open session for public comment and discussion, the panel convenes for consideration of each topic and makes recommendations for positions to the ISCD Board of Directors. Recommendations that are accepted become the Official Positions of the ISCD. This Special Report summarizes the methodology of the ISCD Position Development Conferences and presents selected Official Positions of general interest.

Khan AA, Bachrach L, Brown JP, Hanley DA, Josse RG, Kendler DL, Leib ES, Lentle BC, Leslie WD, Lewiecki EM, Miller PD, Nicholson RL, O'Brien C, Olszynski WP, Theriault MY, Watts NB, Anonymous00235. · Divisions of Endocrinology and Geriatrics, McMaster University, Hamilton, ON, Canada. · J Clin Densitom. · Pubmed #14742888 No free full text.

Abstract: The Canadian Panel of the International Society for Clinical Densitometry has developed standards in order to establish the minimum level of acceptable performance for the practice of bone densitometry in Canada. Previously, this group addressed the performance of densitometry in postmenopausal women. This report addresses the use of densitometry in men, premenopausal women, and children with a focus on dual-energy X-ray absorptiometry.

Leib ES, Lewiecki EM, Binkley N, Hamdy RC, Anonymous00228. · International Society for Clinical Densitometry International Society for Clinical Densitometry, West Hartford, CT 06117-2507, USA. · J Clin Densitom. · Pubmed #14742881 No free full text.

Abstract: The International Society for Clinical Densitometry (ISCD) has convened two Position Development Conferences at which a panel of experts agreed on recommendations for performance and clinical applications of bone density testing. These recommendation were reviewed by the ISCD Board of Directors, and those approved by the board are now official positions of the ISCD. These include (1) indications for bone density testing, (2) reference databases for T-scores, (3) standards for performing central dual-energy X-ray absorptiometry (DXA) for diagnosis, (4) interpretation of peripheral bone density results, (5) diagnosis of osteoporosis in postmenopausal women, (6) diagnosis of osteoporosis in men, (7) diagnosis in premenopausal women, (8) diagnosis in children, (9) indications and interpretation for serial bone mass measurement, (10) technical standards for phantom scanning and calibration, (11) technical standards for cross-calibration of DXAsystems, and (12) standards for reporting of bone density results including correct nomenclature and preferred number of decimal digits.

Lewiecki EM. · No affiliation provided · South Med J. · Pubmed #18090959 No free full text.

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Lewiecki EM. · No affiliation provided · South Med J. · Pubmed #16711302 No free full text.

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Lewiecki EM. · No affiliation provided · South Med J. · Pubmed #16509542 No free full text.

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Lewiecki EM. · No affiliation provided · J Clin Densitom. · Pubmed #11740059 No free full text.

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Lewiecki EM. · New Mexico Clinical Research & Osteoporosis Center, 300 Oak St NE, Albuquerque NM 87106, · Womens Health (Lond Engl). · Pubmed #19274891 No free full text.

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Lewiecki EM. · New Mexico Clinical Research & Osteoporosis Center, 300 Oak Street NE, Albuquerque, New Mexico 87106, USA. · Expert Opin Emerg Drugs. · Pubmed #19249985 No free full text.

Abstract: Postmenopausal osteoporosis (PMO) is a common skeletal disease with serious consequences due to fractures, including increased risk of disability and death. The risk of fractures can be reduced with medications that are currently available; however, these drugs are frequently not prescribed due to failure to recognize that a patient is at high risk for fracture; fear of adverse drug effects; or, sometimes, high cost. When these drugs are prescribed, long-term adherence to therapy is poor. Efforts to improve the clinical effectiveness of pharmacological therapies have included lengthening the interval between doses, simplifying drug administration, and manipulating the molecular structure of drugs in existing therapeutic classes. Recent improvement in understanding the pathophysiology of PMO at the molecular level has fostered the development of new therapeutic agents with novel mechanisms of action. This is a review of the data on the efficacy and safety of emerging drugs for the treatment of PMO, including agents with novel mechanisms of action (denosumab, odanacatib, antibody to sclerostin), new estrogen agonists/antagonists (lasofoxifene, bazedoxifene, arzoxifene), new delivery systems for existing drugs (salmon calcitonin, teriparatide), and drug combinations given concurrently, sequentially, or cyclically. These new therapeutic agents, new delivery systems, and new methods of combining drugs may ultimately reduce the great personal and economic burden of osteoporotic fractures.

Recker RR, Lewiecki EM, Miller PD, Reiffel J. · School of Medicine, Creighton University, Omaha, Nebraska, USA. · Am J Med. · Pubmed #19187809 No free full text.

Abstract: In this review 4 experts consider the major safety concerns relating to bisphosphonate therapy for osteoporosis. Specific topics covered are skeletal safety (particularly with respect to atypical fractures and delayed healing), gastrointestinal intolerance, hypocalcemia, acute-phase (i.e., postdose) reactions, chronic musculoskeletal pain, renal safety, and cardiovascular safety (specifically, atrial fibrillation).

Lewiecki EM, Watts NB. · New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM 87106, USA. · South Med J. · Pubmed #19139693 No free full text.

Abstract: The World Health Organization Fracture Risk Assessment Tool (FRAX) and the National Osteoporosis Foundation's (NOF) Clinician's Guide to Prevention and Treatment of Osteoporosis are helpful clinical tools in the management of osteoporosis. Appropriate use of these tools requires a clear understanding of their limitations as well as their benefits. Good clinical judgment should be the ultimate determinant of treatment decisions. We anticipate that further refinements to FRAX and subsequent updates of the NOF guide will improve their clinical utility.

Lewiecki EM. · No affiliation provided · South Med J. · Pubmed #19077759 No free full text.

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Lewiecki EM, Lane NE. · New Mexico Clinical Research & Osteoporosis Center, University of New Mexico School of Medicine, Albuquerque, NM 87106, USA. · Nat Clin Pract Rheumatol. · Pubmed #18936788 No free full text.

Abstract: Bone mineral density (BMD) testing is used to diagnose osteoporosis, assess fracture risk and monitor changes in BMD over time. A variety of devices and technologies are used to measure BMD or other surrogate markers of bone strength. Measurements obtained with these devices are often reported according to different proprietary standards, and the comparability of values obtained with different instruments is often poor. In addition, there is a high degree of variability in the skills of the technologists performing the tests and the clinicians interpreting the results. Heterogeneity in the guidelines for using BMD measurements together with poor-quality BMD testing and reporting can result in inappropriate clinical decisions, causing unnecessary worry and expense for the patient and possible harm due to unnecessary treatment or treatment being withheld. This Review describes and discusses the mistakes commonly made in BMD testing, and emphasizes the importance of maintaining high-quality standards in order to optimize patient management.

Lewiecki EM. · New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM 87106, USA. · J Clin Densitom. · Pubmed #18757222 No free full text.

Abstract: Osteoporotic fractures may lead to pain, disability, impaired quality of life, and increased risk of death, with annual health-care costs of $17 billion or more. Oral bisphosphonates, the first-line treatment for postmenopausal osteoporosis (PMO), increase bone mineral density and reduce the risk of fracture, but dosing requirements are complex and compliance and persistence are poor. The newest bisphosphonate treatment option, intravenous (IV) zoledronic acid (ZOL) every 12mo, has been shown to reduce the risk of vertebral, hip, and other nonvertebral fractures. Long-dosing intervals and 100% bioavailability with IV bisphosphonate therapy address some of the limitations associated with oral bisphosphonates. This is a review of the clinical trial data supporting the use of IV ZOL to reduce fracture risk, and its potential role in the management of PMO in clinical practice.

Lewiecki EM. · New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM 87106, USA. · Obstet Gynecol Clin North Am. · Pubmed #18486843 No free full text.

Abstract: Osteoporosis is a common skeletal disease characterized by reduced bone strength and increased risk for fractures. Fragility fractures are associated with serious clinical consequences, including chronic pain, skeletal deformities, loss of independence, and increased mortality. Although osteoporosis is underdiagnosed and undertreated, many who are treated take medication incorrectly or do not continue it long enough to benefit. Measures to prevent osteoporosis include a healthy lifestyle, with regular physical activity, adequate intake of calcium and vitamin D, and avoidance of cigarette smoking and excess alcohol. Patients at risk for osteoporosis can be diagnosed with a simple bone density test before the first fracture occurs. Pharmacologic agents for patients at high risk for fracture can reduce the burden of osteoporotic fractures.

Lewiecki EM. · New Mexico Clinical Research & Osteoporosis Center, 300 Oak Street NE, Albuquerque, NM 87106, USA. · Curr Osteoporos Rep. · Pubmed #18430396 No free full text.

Abstract: Osteoporosis is a preventable disease characterized by loss of bone mineral density, progression to diminished skeletal integrity, extensive bone fragility, and an increased risk of fracture. Morbidity and mortality from osteoporosis are significant, and the public health costs are substantial. Although safe and effective therapy is available, the disease remains underdiagnosed and undertreated. Oral bisphosphonates such as alendronate, risedronate, and ibandronate are the current first-line therapy; however, adherence to treatment is suboptimal, largely because the treatment regimen is difficult to follow. The bisphosphonate zoledronic acid (zoledronate), 5 mg, is administered as an annual 15-minute intravenous infusion for the treatment of postmenopausal osteoporosis, assuring treatment compliance and persistence over the 12-month dosing interval. The drug is safe and generally well tolerated, and provides sustained anti-fracture efficacy at all relevant skeletal sites. Zoledronic acid has the potential to improve clinical outcomes by reducing the risk of fracture in patients with osteoporosis.

Owens G, Jackson R, Lewiecki EM. · · Am J Manag Care. · Pubmed #18095779 links to  free full text

Abstract: Osteoporosis is underrecognized and undertreated despite the availability of effective therapies that reduce fracture risks. Bisphosphonates are currently the most widely prescribed pharmacologic treatment for osteoporosis. Oral bisphosphonates are typically managed under the pharmacy benefit of a health plan. With the recent availability of intravenous bisphosphonates, osteoporosis therapies now cross both the traditional pharmacy and medical benefit boundaries. Determining the most appropriate and cost-effective treatment for specific populations requires best practices that integrate both pharmacy and medical benefit considerations. When developing policy as part of these best practices, medical directors and pharmacy directors must consider efficacy, safety, cost, convenience, and mode of administration for each of the bisphosphonate formulations. This continuing education activity, based on a roundtable of managed care experts, explores new approaches for developing an effective bisphosphonate management policy for the treatment of osteoporosis.

Lewiecki EM, Miller PD. · University of New Mexico School of Medicine, Albuquerque, New Mexico, USA. · Expert Opin Drug Saf. · Pubmed #17967155 No free full text.

Abstract: Oral bisphosphonates are the mainstay of treatment for osteoporosis but cannot be used in some patients due to gastrointestinal contraindications, gastrointestinal intolerance, malabsorption or the inability to comply with dosing requirements. In such patients, intravenous bisphosphonates are a useful alternative. This review summarises the renal safety issues associated with the use of intravenous bisphosphonates for osteoporosis. Intravenous bisphosphonates are generally well tolerated, which may be a reflection of their selective activity in bone and metabolic stability. Adverse effects on renal function are primarily related to infusion rate and dose. Due to lack of data, no conclusions can be made regarding bisphosphonate safety in patients with intrinsic renal disease or an estimated glomerular filtration rate of < 30 ml/min.