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Biomedical subjects

N B Watts

Publications and source records attributed to N B Watts.

At least 19 recordsLinked to original sources
PubMed2002

Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis.

The aim of this study was to provide confirmation that once-weekly dosing with 70 mg of alendronate (seven times the daily oral dose) and twice-weekly dosing with 35 mg is equivalent to the 10-mg once-daily regimen and to gain more extensive safety experience with this new dosing regimen. Twelve hundred fifty-eight postmenopausal women (aged 42-95 years) with osteoporosis (bone mineral density [BMD] of either lumbar spine or femoral neck at least 2.5 SDs below peak young adult mean or prior vertebral or hip fracture) were assigned to receive oral once-weekly alendronate, 70 mg (n = 519); twice-weekly alendronate, 35 mg (n = 369); or daily alendronate 10 mg (n = 370) for a total of 2 years of double-blind experience. Mean BMD increases from baseline (95% CI) at 24 months in the once-weekly, twice-weekly, and daily treatment groups, respectively, were 6.8% (6.4, 7.3), 7.0% (6.6,7.5), and 7.4% (6.9,7.8) at the lumbar spine and 4.1% (3.8,4.5), 4.3% (3.9,4.7), and 4.3% (3.9,4.7) at the total hip. These increases in BMD as well as the BMD increases at the femoral neck, trochanter, and total body and the reductions of biochemical markers of bone resorption (urinary cross-linked N-telopeptides of type I collagen [NTx]) and bone formation (serum bone-specific alkaline phosphatase [BSAP]) were similar for the three dosing regimens. All treatment regimens were well tolerated with a similar incidence of upper gastrointestinal (GI) adverse experiences. The incidence rates of clinical fractures, captured as adverse experiences, were similar among the groups. The 2-year results confirm the conclusion reached after 1 year that once-weekly alendronate is therapeutically equivalent to daily dosing, providing patients with a more convenient dosing option that may potentially enhance adherence to therapy.

Adult↗
PubMed2002

Standards and guidelines for performing central dual X-ray densitometry from the Canadian panel of International Society for Clinical Densitometry.

The International Society for Clinical Densitometry (ISCD) is a multidisciplinary nonprofit global organization formed to ensure excellence in densitometry imaging, interpretation, and application. The Canadian panel of the ISCD represents ISCD in Canada and oversees Canadian bone densitometry certification programs. The standards of care from the Canadian panel of the ISCD have been developed in order to establish the minimum level of acceptable performance for the practice of bone densitometry in Canada. A variety of techniques are available for skeletal assessment of bone mineral density, which vary in accuracy, precision, and clinical utility as well as availability. This article focuses on central dual X-ray absorptiometry in adults and does not address densitometry in the pediatric population. Other technologies will be addressed in a subsequent article.

Absorptiometry, Photon↗
PubMed2001

Risedronate for the prevention and treatment of postmenopausal osteoporosis: results from recent clinical trials.

Postmenopausal osteoporosis is a widespread condition that affects the physical and emotional well-being of millions of women worldwide. In the clinical trials reviewed here, antiresorptive therapy using the bisphosphonate, risedronate, significantly reduced the incidence of vertebral and nonvertebral fractures, increased BMD in both early and late menopausal women, and decreased biochemical measures of bone resorption. The safety profile of risedronate appears comparable to placebo. These findings demonstrate that risedronate is effective and well tolerated for the prevention and treatment of postmenopausal osteoporosis.

Aged↗
PubMed2001

Treatment of painful osteoporotic vertebral fractures with percutaneous vertebroplasty or kyphoplasty.

Vertebral fracture is the most common complication of osteoporosis. It results in significant mortality and morbidity, including prolonged and intractable pain in a minority of patients. Vertebroplasty and kyphoplasty, procedures that involve percutaneous injection of bone cement into a collapsed vertebra, have recently been introduced for treatment of osteoporotic patients who have prolonged pain (several weeks or longer) following vertebral fracture. To determine the details of the procedures and to gather information on their safety and efficacy, we performed a MEDLINE search using the terms 'vertebroplasty' and 'kyphoplasty.' We reviewed reports of these procedures in patients with osteoporosis. We supplemented the articles found with other papers known to the authors and with presentations at national meetings. Randomized trials of vertebroplasty and kyphoplasty have not been reported. Case reports suggest that these procedures are associated with pain relief in 67% to 100% of cases. Short-term complications, mainly the result of extravasation of cement, include increased pain and damage from heat or pressure to the spinal cord or nerve roots. Proper patient selection and good technique should minimize complications, but rarely, decompressive surgery is needed. Long-term benefits have not yet been shown, but potentially include prevention of recurrent pain at the treated level(s) with both procedures, and, with kyphoplasty, reversal of height loss and spinal deformity, an improved level of function, and avoidance of chronic pain and restriction of internal organs. Possible long-term complications, again not fully evaluated, include local acceleration of bone resorption caused by the treatment itself or by foreign-body reaction at the cement-bone interface, and increased risk of fracture in treated or adjacent vertebrae through changes in mechanical forces. Controlled trials are needed to determine both short-term and long-term safety and efficacy of vertebroplasty and kyphoplasty. Both procedures may be useful for osteoporotic patients who have prolonged pain following acute vertebral fracture. Until there is conclusive evidence for efficacy and long-term safety, these procedures should be done only in carefully selected patients, only by experienced operators with appropriate high-quality imaging equipment, and ideally at centers that are participating in controlled trials.

Back Pain↗
PubMed2001

Comparison of bone and total alkaline phosphatase and bone mineral density in postmenopausal osteoporotic women treated with alendronate.

Alendronate therapy in osteoporotic women decreases bone turnover and increases bone mineral density (BMD). Optimal patient management should include verification that each patient is responding to therapy. Markers of bone turnover and BMD have both been proposed for this purpose. We have investigated changes resulting from alendronate therapy with an enzyme immunoassay for bone alkaline phosphatase (BAP) and compared it with total alkaline phosphatase (TAP) and BMD of the lumbar spine, hip, and total body. Subjects were drawn from a multicenter randomized, placebo-controlled trial of alendronate in postmenopausal women with osteoporosis. BAP and TAP levels were measured at baseline and following 3, 6 and 12 months of therapy with either placebo (n = 180) or alendronate 10 mg/day (n = 134). All subjects also received 500 mg/day supplemental calcium. BMD was measured at baseline and following 3, 6, 12, 18, 24 and 36 months of therapy. To compare BAP, TAP and BMD at each site for identifying women that experienced a skeletal effect of alendronate, we calculated least significant change (LSC) values from the long-term intraindividual variability in each placebo-treated woman. Median levels of BAP decreased by 34%, 44% and 43% at 3, 6 and 12 months, respectively, in alendronate-treated women (p < 0.0001 compared with baseline and with placebo). These changes were significantly greater (p < 0.0001) than changes observed for TAP. Following 6 months of alendronate therapy, 90% of the women had experienced a decrease in BAP exceeding the LSC compared with only 71% for TAP. The greatest number of women similarly identified with BMD at any site (i.e. a gain in BMD exceeding the LSC) was 81% for spinal BMD at 36 months. All other sites were less than 70% at 36 months. Short-term changes in BAP and TAP were modestly associated with subsequent changes in BMD at all sites (Spearman's rho -0.22 to -0.52, p < 0.05). Compared with TAP and BMD, BAP testing rapidly and sensitively identified skeletal effects of alendronate thus enabling appropriate drug monitoring of osteoporotic women. Though BAP and TAP changes were modestly predictive of BMD changes, the value of the bone marker tests is their ability to detect rapidly a skeletal effect of therapy.

Aged↗
PubMed2001

Treatment of osteoporosis with bisphosphonates.

Bisphosphonates are safe and effective agents for treatment and prevention of osteoporosis. Alendronate and risedronate are the best studied of all agents for osteoporosis in terms of efficacy and safety. They increase bone mass. In patients who have established osteoporosis, they reduce the risk of vertebral fractures. They are the only agents shown in prospective trials to reduce the risk of hip fractures and other nonvertebral fractures. They are approved by the US FDA for prevention of bone loss in recently menopausal women, for treatment of postmenopausal osteoporosis, and for management of glucocorticoid-induced bone loss. Other bisphosphonates (e.g., etidronate for oral use, pamidronate for intravenous infusion) are also available and can be used off-label for patients who cannot tolerate approved agents. Bisphosphonates combined with estrogen produce greater gains in bone mass compared with either agent used alone; whether there is a greater benefit of combination therapy on fracture risk is not clear. Combining a bisphosphonate with raloxifene or calcitonin is probably safe, although data on effectiveness are lacking.

Aged↗
PubMed2001

Risk factors for kidney stones in older women in the southern United States.

BACKGROUND: The occurrence of kidney stones is disproportionate in the southern region of the United States. Risk factors for the occurrence of kidney stones in this geographic area have not been reported previously. METHODS: The Women's Health Initiative (WHI) is an ongoing multicenter clinical investigation of strategies for the prevention of common causes of morbidity and mortality among postmenopausal women. A case-control ancillary study was conducted on 27,410 (white or black) women enrolled in the 9 southern WHI clinical centers. There were 1,179 cases (4.3%) of kidney stones at the baseline evaluation. Risk factors for stone formation were assessed in cases versus age- and race-matched control subjects. RESULTS: Risk factors (univariate) included low dietary potassium (2,404 versus 2,500 mg/day, P = 0.006), magnesium (243 versus 253 mg/day, P = 0.003) and oxalate (330 versus 345 mg/day, P = 0.02) intake, as well as increased body mass index (28.5 versus 27.7 kg/m2, P = 0.001) and a history of hypertension (42% versus 34%, P = 0.001). A slightly lower dietary calcium intake (683 versus 711 mg/day, P = 0.04) was noted in case subjects versus control subjects, but interpretation was confounded by the study of prevalent rather than incident cases. Supplemental calcium intake >500 mg/day was inversely associated with stone occurrence. CONCLUSION: Multivariate risk factors for the occurrence of kidney stones in postmenopausal women include a history of hypertension, a low dietary intake of magnesium, and low use of calcium supplements.

Age Factors↗
PubMed2000

Bisphosphonates: safety and efficacy in the treatment and prevention of osteoporosis.

Osteoporosis affects more than 28 million Americans. With the advent of accessible and affordable diagnostic studies, awareness and recognition of this disease by patients and clinicians are growing. Osteoporotic fractures of the spine and hip are costly and associated with significant morbidity and mortality. Over the past decade, a surge of new antiosteoporotic drugs have been labeled or are awaiting labeling by the U.S. Food and Drug Administration. One class of agents used to treat osteoporosis is the bisphosphonates, which inhibit bone resorption, cause an increase in bone mineral density and reduce the risk of future fractures caused by aging, estrogen deficiency and corticosteroid use. Overall, bisphosphonates have been shown to have a strong safety and tolerability profile.

Alendronate↗
PubMed2000

Clinical use of biochemical markers of bone remodeling: current status and future directions.

Biochemical markers of bone turnover provide a means of evaluating skeletal dynamics that complements static measurements of bone mineral density (BMD). This review evaluates the use of commercially available bone turnover markers as aids in diagnosis and monitoring response to treatment in patients with osteoporosis. High within-person variability complicates but does not preclude their use. Elevated bone resorption markers appear to be associated with increased fracture risk in elderly women, but there is less evidence of a relationship between bone formation markers and fracture risk. The critical question of predicting fracture efficacy with treatment has not been answered. Changes in bone markers as currently determined do not predict BMD response to either bisphosphonates or hormone replacement therapy. Single measurements of markers do not predict BMD cross-sectionally (except possibly in the very elderly), or change in BMD in individual patients, either treated or untreated. On the other hand, research applications of bone turnover markers are of value in investigating the pathogenesis and treatment of bone diseases. Markers have potential in the clinical management of osteoporosis, but their use in this regard is not established. Additional studies with fracture endpoints and information on negative and positive predictive value are needed to evaluate fully the utility of bone turnover markers in individual patients.

Biomarkers↗
PubMed2000

Focus on primary care postmenopausal osteoporosis: an update.

Osteoporosis is a common and costly condition that can cause disability or death. Evaluation of patients for possible secondary causes is important. Bone density testing permits identification of individuals who are at high risk of fracture and is recommended for all women age 65 and older and for younger women who have clinical risk factors. Measurement of bone markers, particularly collagen cross links, may add some information. Adequate calcium, vitamin D, and weight-bearing exercise are important for everyone and are fundamental to any program for prevention of bone loss or treatment of osteoporosis. Effective pharmacologic agents are available for prevention of bone loss in recently menopausal women and for treatment of established osteoporosis. Pharmacologic intervention is indicated for women who have osteoporosis, defined either as a fracture or BMD T-score of -2.5 and below.

Bone Density↗
PubMed1999

Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group.

CONTEXT: Risedronate, a potent bisphosphonate, has been shown to be effective in the treatment of Paget disease of bone and other metabolic bone diseases but, to our knowledge, it has not been evaluated in the treatment of established postmenopausal osteoporosis. OBJECTIVE: To test the efficacy and safety of daily treatment with risedronate to reduce the risk of vertebral and other fractures in postmenopausal women with established osteoporosis. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial of 2458 ambulatory postmenopausal women younger than 85 years with at least 1 vertebral fracture at baseline who were enrolled at 1 of 110 centers in North America conducted between December 1993 and January 1998. INTERVENTIONS: Subjects were randomly assigned to receive oral treatment for 3 years with risedronate (2.5 or 5 mg/d) or placebo. All subjects received calcium, 1000 mg/d. Vitamin D (cholecalciferol, up to 500 IU/d) was provided if baseline levels of 25-hydroxyvitamin D were low. MAIN OUTCOME MEASURES: Incidence of new vertebral fractures as detected by quantitative and semiquantitative assessments of radiographs; incidence of radiographically confirmed nonvertebral fractures and change from baseline in bone mineral density as determined by dual x-ray absorptiometry. RESULTS: The 2.5 mg/d of risedronate arm was discontinued after 1 year; in the placebo and 5 mg/d of risedronate arms, 450 and 489 subjects, respectively, completed all 3 years of the trial. Treatment with 5 mg/d of risedronate, compared with placebo, decreased the cumulative incidence of new vertebral fractures by 41 % (95% confidence interval [CI], 18%-58%) over 3 years (11.3 % vs 16.3%; P= .003). A fracture reduction of 65% (95% CI, 38%-81 %) was observed after the first year (2.4% vs 6.4%; P<.001). The cumulative incidence of nonvertebral fractures over 3 years was reduced by 39% (95% CI, 6%-61 %) (5.2 % vs 8.4%; P = .02). Bone mineral density increased significantly compared with placebo at the lumbar spine (5.4% vs 1.1 %), femoral neck (1.6% vs -1.2%), femoral trochanter (3.3% vs -0.7%), and midshaft of the radius (0.2% vs -1.4%). Bone formed during risedronate treatment was histologically normal. The overall safety profile of risedronate, including gastrointestinal safety, was similar to that of placebo. CONCLUSIONS: These data suggest that risedronate therapy is effective and well tolerated in the treatment of women with established postmenopausal osteoporosis.

Aged↗
PubMed1999

Alendronate increases spine and hip bone mineral density in women with postmenopausal osteoporosis who failed to respond to intermittent cyclical etidronate.

In a U.S. multicenter study of intermittent cyclical etidronate treatment for postmenopausal osteoporosis, approximately 20% of patients were nonresponders, defined as failure to increase spine bone mineral density. In contrast, essentially all patients who received 10 mg of alendronate daily in U.S. phase III trials showed some increase in spine bone mineral density. The current study was undertaken to determine the response to alendronate therapy in women with postmenopausal osteoporosis who were nonresponders to intermittent cyclical etidronate therapy. Twenty-five women with postmenopausal osteoporosis (mean +/- SD: 65.1+/-1.9 years of age), previously treated with intermittent cyclical etidronate with no increase of spine bone mineral density, and who agreed to be changed to alendronate, were recruited from a university out-patient clinic specializing in the treatment of osteoporosis for a prospective observational study. Measurements included bone mineral density of the lumbar spine and proximal femur (by dual-energy X-ray absorptiometry) and biochemical markers of bone remodeling (serum bone-specific alkaline phosphatase by immunoassay and urine deoxypyridinoline by high-pressure liquid chromatography). Patients had received intermittent cyclical etidronate for 3.3+/-0.4 years, during which time their bone density declined at spine and hip sites. They were then changed to alendronate 10 mg/day, which they received for 1.3+/-0.1 years; after treatment with alendronate, bone mineral density increased significantly at the lumbar spine (4.4+/-0.7% annualized,p < 0.0001) and at all hip sites. Bone markers also changed significantly after alendronate treatment: urine deoxypyridinoline fell from 6.8+/-0.8 to 5.5+/-0.6 micromol/mol creatinine (p < 0.0001) and serum bone-specific alkaline phosphatase rose from 4.6+/-0.5 to 11.9+/-1.0 ng/mL (p < 0.0001). Upper gastrointestinal side effects forced 4 of 25 patients (16%) to discontinue alendronate. Alendronate increases bone density at the spine and hip in patients who have not responded to intermittent cyclical etidronate therapy. Changes in bone markers suggest that alendronate causes more complete suppression of bone resorption and less inhibition (or stimulation) of bone formation.

Absorptiometry, Photon↗
PubMed1999

Postmenopausal osteoporosis.

UNLABELLED: Osteoporosis affects approximately 28 million Americans and costs about $14 billion a year. Low bone density is the most important risk factor for osteoporosis. The National Osteoporosis Foundation recommends bone density testing for all women over 65 and earlier (around the time of menopause) for women who have risk factors or who are considering therapy. Biochemical markers of bone remodeling, such as urine collagen cross links, may be useful to decide if treatment is needed and to determine the effectiveness of treatment. Once the diagnosis of osteoporosis is made, it is time to consider management options. A healthy life style is important for everyone: an adequate intake of calcium and vitamin D and regular weight-bearing exercise. Pharmacologic agents are indicated for all patients with fragility fractures and for many patients with low bone density. Estrogen is the agent of choice for both prevention and treatment of postmenopausal osteoporosis; however, once estrogen is stopped, bone mass levels drop fairly quickly. Long-term adherence to hormone replacement therapy is not good. Effective alternatives for prevention of bone loss in recently menopausal women include alendronate (a bisphosphonate) and raloxifene (a selective estrogen-receptor modulator). Effective alternatives for treatment of established osteoporosis include alendronate and nasal calcitonin. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians LEARNING OBJECTIVES: After completion of this article, the reader will be able to understand the clinical impact and sequlae of osteoporosis in women, how to identify the high risk patient and those patient that should be screened, the various tests that are available for screening and monitoring, and the various pharmacologic therapies for osteoporosis.

Biomarkers↗
PubMed1999

Understanding the Bone Mass Measurement Act.

The Bone Mass Measurement Act (BMMA) set forth regulations to provide for uniform coverage under Medicare Part B for bone mass measurements for services provided on or after July 1, 1998. The BMMA authorizes Medicare coverage of "medically necessary approved measurements" performed for a "qualified individual" who falls into at least one of five diagnostic categories: an estrogen-deficient woman at clinical risk for osteoporosis; an individual with vertebral abnormalities; an individual receiving long-term glucocorticoid (steroid) therapy; an individual with primary hyperparathyroidism; and an individual being monitored to assess the response to, or efficacy of, an approved osteoporosis drug therapy. Proper communication is essential for reimbursement. The tools for communication include Physician's Current Procedural Terminology (CPT), HCFA (Health Care Financing Administration) Common Procedure Coding System (HCPCS), the Medicare carrier's local Medical Review Policy (LMRP), and the International Classification of Diseases, ninth revision (ICD-9). This article reviews the new regulations and the tools for communication.

Absorptiometry, Photon↗
PubMed1999

Practical clinical application of biochemical markers of bone turnover: Consensus of an expert panel.

Biochemical markers of bone turnover have emerged as powerful tools to aid in managing osteoporosis. The newer bone markers have been intensively studied for more than a decade. As a result, we can now confidently report their clinical utility in assessing risk of rapid bone loss and fracture, and monitoring therapy in postmenopausal women with or at risk of osteoporosis. In this review, we will provide a comprehensive foundation for this utility. While there are still questions remaining to be answered, bone marker technology has matured to play an essential role in patient management. We will describe, in practical terms, how bone markers can be appropriately incorporated into clinical practice today.

Aged↗