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Michael McClung

Publications and source records attributed to Michael McClung.

9 recordsLinked to original sources

Application of the 1994 WHO classification to populations other than postmenopausal Caucasian women: the 2005 ISCD Official Positions.

In 2003, the International Society for Clinical Densitometry (ISCD) developed Official Positions regarding the applicability of the World Health Organization (WHO) classification of bone mineral density to populations other than postmenopausal women. However, these prior Official Positions do not fully address bone mineral density reporting in females prior to menopause, men, and non-whites. During the 2005 ISCD Position Development Conference, members of the ISCD Expert Panel in conjunction with the ISCD Scientific Advisory Committee re-addressed these topics and, based upon stringent reviews of best available data, developed ISCD Official Positions that provide greater specificity and clarification with respect to the following: (1) the utility of the term 'osteopenia'; (2) utilization of T- and Z-scores for bone mineral density reporting; (3) when to apply the WHO densitometric classification; and (4) which normative database(s) should be used for non-white individuals. Briefly, the term "osteopenia" is retained, but 'low bone mass' or 'low bone density' is preferred. Z-scores, not T-scores, are preferred in females prior to menopause and males under age 50. In these individuals, a Z-score of -2.0 or lower is defined as "below the expected range for age" and a Z-score above -2.0 is "within the expected range for age." T-scores are preferred and the WHO classification is applicable for postmenopausal women and men age 50 and older. These Official Positions, rationale and evidence are discussed in the following report.

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Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years.

OBJECTIVE: A 1-yr extension of the Fosamax Actonel Comparison Trial was completed to compare changes in bone mineral density (BMD), bone turnover, and upper gastrointestinal tolerability over 2 yr of treatment. DESIGN: This was a randomized, double-blind extension conducted at 72 U.S. sites. PATIENTS AND METHODS: Of the 1053 women who completed yr 1, 833 postmenopausal women with low BMD entered the extension, continuing their same treatment allocation [once-weekly (OW) alendronate 70 mg or OW risedronate 35 mg]. Changes in BMD at the hip trochanter, total hip, femoral neck, and lumbar spine and in markers of bone turnover were compared at 24 months. Tolerability was assessed by adverse experience reporting. RESULTS: Alendronate produced greater increases from baseline in BMD at 24 months than did risedronate at the trochanter (alendronate, 4.6%; risedronate, 2.5%, P < 0.001) as well as at all other BMD sites. Significantly more alendronate than risedronate patients had measured BMD increases of 0% or more and 3% or more at all BMD sites (P < 0.001), and fewer alendronate patients had measured decreases of 3% or more at all BMD sites. Significantly greater reductions in all biochemical markers of bone turnover occurred with alendronate, compared with risedronate. No differences were seen in occurrence or discontinuations due to upper gastrointestinal adverse experiences. CONCLUSIONS: Patients receiving 70 mg OW alendronate had greater gains in BMD, were more likely to maintain or gain BMD, and had greater reductions in bone turnover markers than patients receiving 35 mg OW risedronate after 24 months, with no differences in upper gastrointestinal tolerability.

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Bisphosphonates.

Osteoporosis is the result of bone loss due to an imbalance in bone turnover such that bone resorption exceeds bone formation. Bisphosphonates are potent inhibitors of osteoclast activity that reduce bone turnover and re-establish the balance between bone resorption and formation. In clinical studies, several bisphosphonates prevent bone loss, preserve bone structure, improve bone strength and, in patients with osteoporosis, substantially reduce fracture risk. They are effective in multiple clinical settings including postmenopausal osteoporosis, low bone mass in men and drug-induced bone loss. Intermittent oral dosing and intravenous administration are more convenient than the original daily dosing regimen. These drugs are generally well tolerated and have an excellent safety profile in that serious side effects are uncommon. Potent bisphosphonates are generally the preferred treatment option for most patients with or at risk for osteoporosis.

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Lebanese guidelines for osteoporosis assessment and treatment: who to test? What measures to use? When to treat?

With the demographic explosion of the population worldwide, the human, social, and economic costs of osteoporosis will continue to rise. It is estimated that the magnitude of the problem might be even larger in developing countries, including those in the Middle East. Although several organizations and countries have developed or adapted guidelines to their local needs, as of today there are no guidelines for osteoporosis assessment in the Middle East. In April 2002, a panel of osteoporosis experts met and discussed practice guidelines for osteoporosis assessment and treatment in Lebanon. The process, which involved an overview of international guidelines as well as local data on osteoporosis, resulted in a draft for Lebanese guidelines that addressed three main questions: "Who to test?" "What measures to use?" and "When to treat?". Representatives from five major Lebanese societies (Endocrinology, Rheumatology, Orthopedics, Obstetrics and Gynecology, and Radiology) subsequently reviewed, discussed, and officially endorsed the guidelines after revisions. The Lebanese guidelines were also endorsed by the Eastern Mediterranean branch of the World Health Organization.

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Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study.

UNLABELLED: Once-weekly alendronate 70 mg and once-weekly risedronate 35 mg are indicated for the treatment of postmenopausal osteoporosis. These two agents were compared in a 12-month head-to-head trial. Greater gains in BMD and greater reductions in markers of bone turnover were seen with alendronate compared with risedronate with similar tolerability. INTRODUCTION: The nitrogen-containing bisphosphonates, alendronate and risedronate, are available in once-weekly (OW) formulations for the treatment of postmenopausal osteoporosis. A 12-month, head-to-head study was performed to compare these agents in the treatment of postmenopausal women with low BMD. MATERIALS AND METHODS: A total of 1053 patients from 78 U.S. sites were randomized to OW alendronate 70 mg (N = 520) or risedronate 35 mg (N = 533), taken in the morning after fasting. Endpoints included BMD changes over 6 and 12 months at the hip trochanter, total hip, femoral neck, and lumbar spine (LS); percent of patients with predefined levels of change in trochanter and LS BMD at 12 months; and change in biochemical markers of bone turnover at 3, 6, and 12 months. Tolerability was evaluated by adverse experience (AE) reporting. RESULTS: Significantly greater increases in hip trochanter BMD were seen with alendronate (3.4%) than risedronate (2.1%) at 12 months (treatment difference, 1.4%; p < 0.001) as well as 6 months (treatment difference, 1.3%; p < 0.001). Significantly greater gains in BMD were seen with alendronate at all BMD sites measured (12-month difference: total hip, 1.0%; femoral neck, 0.7%; LS, 1.2%). Significant differences were seen as early as 6 months at all sites. A greater percentage of patients had > or =0% (p < 0.001) and > or =3% (p < 0.01) gain in trochanter and spine BMD at 12 months with alendronate than risedronate. Significantly greater (p < 0.001) reductions in all biochemical markers of bone turnover occurred with alendronate compared with risedronate by 3 months. No significant differences were seen between treatment groups in the incidence of upper gastrointestinal AEs or AEs causing discontinuation. CONCLUSIONS: In this 12-month, head-to-head trial of alendronate and risedronate, given in accordance with the approved OW regimens for treatment of osteoporosis in postmenopausal women, alendronate produced greater gains in BMD and greater reductions in markers of bone turnover than risedronate. The greater antiresorptive effect of alendronate was seen as early as 3 months, and the tolerability profiles were similar.

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Parathyroid hormone for the treatment of osteoporosis.

UNLABELLED: Imbalances in bone metabolism result in bone mass loss and skeletal fragility in postmenopausal women and older men. Most osteoporosis treatments decrease bone metabolism and prevent the progression of bone loss and architectural damage to the skeleton. Analogs of parathyroid hormone stimulate the formation of new bone and offer new options for managing osteoporosis. This review highlights the effects of parathyroid hormone on bone density and fracture risk in patients with osteoporosis and addresses several of the important issues pertaining to the use of these new agents in daily clinical practice. TARGET AUDIENCE: Obstetricians and Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader should be able to summarize the different mechanisms of action between parathyroid hormone analogues and antiresorptive drugs, to outline the effects of teriparatide treatment of patients with osteoporosis, and list the indications of teriparatide therapy.

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Use of highly potent bisphosphonates in the treatment of osteoporosis.

Bisphosphonates are effective inhibitors of bone remodeling. In the clinical setting, these agents prevent bone loss, preserve bone architecture, and improve bone strength. Clinically significant reduction in the risk of spine and nonspine fractures is observed in patients known to be at risk for fracture. When administered appropriately, these drugs are well tolerated and have an excellent safety profile. Potent bisphosphonates are now the preferred treatment option to reduce the fracture risk in men and women with involutional and glucocorticoid-induced osteoporosis.

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The long-term effect of specific type II 5alpha-reductase inhibition with finasteride on bone mineral density in men: results of a 4-year placebo controlled trial.

PURPOSE: We determine the effect of long-term suppression of dihydrotestosterone with finasteride, a specific type II 5alpha-reductase inhibitor, on bone mineral density. MATERIALS AND METHODS: As part of a large (3,040 cases) 4-year, double-blind, placebo controlled trial designed to assess the long-term effects of finasteride in men with benign prostatic hyperplasia, 157 men 46 to 76 years old who were randomized to receive either 5 mg. finasteride or placebo underwent dual energy x-ray absorptiometry of the lumbar spine at baseline and at years 2, 3 and 4. RESULTS: Of 117 patients who had a baseline measurement and at least 1 additional measurement during the study baseline mean plus or minus standard deviation bone mineral density values were 1.12 +/- 0.17 gm./cm.2 in the finasteride group (63) and 1.10 +/- 0.17 gm./cm.2 in the placebo group (54). After 4 years bone mineral density was not different between treatment groups (finasteride 1.14 +/- 0.17 gm./cm.2 and placebo 1.13 +/- 0.18 gm./cm.2). Similar results were obtained for the 33 finasteride and 25 placebo treated patients who completed the study with year 4 bone mineral density measurements. CONCLUSIONS: These data demonstrate that long-term inhibition of type II 5alpha-reductase with finasteride does not adversely affect bone mineral density.

5-alpha Reductase Inhibitors↗