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PubMed2004

Bone remodeling increases substantially in the years after menopause and remains increased in older osteoporosis patients.

UNLABELLED: Bone remodeling rates (Ac.f) were measured in transilial biopsy specimens from 50 healthy premenopausal women before and 1 year after menopause, in 34 healthy women 13 years past menopause, and in 89 women with untreated osteoporosis. Ac.f nearly doubled 1 year after menopause, tripled 13 years after menopause, and remained elevated in women with osteoporosis. INTRODUCTION: Increased bone remodeling rates are associated with increased skeletal fragility independent of bone mass, partially accounting for the age-related increase in fracture risk in women that is independent of bone loss. We examined bone remodeling rates before and after menopause and in women with osteoporosis by measurements of activation frequency (Ac.f, #/year) in transilial bone biopsy specimens. MATERIALS AND METHODS: We recruited 75 women, > 46 years old, who had premenopausal estradiol and gonadotropin levels and regular menses. During 9.5 years of observation, 50 women experienced normal menopause and had 2 transilial bone biopsy specimens after tetracycline labeling, one at the beginning of observation and the second 12 months after the last menses, when serum follicle-stimulating hormone (FSH) was > 75 mIU/ml and serum estradiol was < 20 pg/ml. Ac.f was also computed for a group of older healthy postmenopausal women and a group of women with untreated osteoporosis studied earlier by the same biopsy (Bx) and labeling protocol. RESULTS: Median Ac.f rose from 0.13/year to 0.24/year (p < 0.001) across menopause and was greater still in the older normals (p < 0.008) than in the second Bx. Ac.f was not significantly greater in the osteoporosis patients than in the older postmenopausal normals. CONCLUSION: Bone remodeling rates double at menopause, triple 13 years later, and remain elevated in osteoporosis. This change contributes to increases in age-related skeletal fragility in women.

Aged↗
PubMed2006

Effect of the Women's Health Initiative on osteoporosis therapy and expenditure in Medicaid.

UNLABELLED: Decreasing HRT use among postmenopausal women may have a reciprocal impact on other osteoporosis therapy. Time series analysis of prescribing trends for millions of Medicaid beneficiaries revealed a 57% decline in HRT without augmenting the pace of bisphosphonate use. Prescribing changes dramatically increased Medicaid spending on osteoporosis therapy over the last decade and requires further evaluation of cost effectiveness. INTRODUCTION: Hormone replacement therapy (HRT) has been commonly prescribed to postmenopausal women, but its use is decreasing because adverse cardiac outcomes were reported by the Women's Health Initiative (WHI) in July 2002. The reciprocal impact of the WHI on other osteoporosis medications use and expenditure is unknown. MATERIALS AND METHODS: We conducted a time series analysis on prescription data from 50 state Medicaid programs between 1995 and 2004. Five medication categories were used: HRT, bisphosphonates, calcium, calcitonin, and raloxifene. RESULTS: HRT was increasing before publication of the WHI, reaching 5 million prescriptions per year by mid-2002 (136 prescriptions per 1000 beneficiaries). Bisphosphonate prescribing rose in parallel until mid-2002. WHI publication was associated with a rapid reduction in HRT use, declining 57% by mid-2004 to an average of 59 prescriptions per 1000 beneficiaries (p = 0.01). WHI publication did not augment bisphosphonates' nearly linear rate of rise (p = 0.43) as their prescribing pace continued, whereas HRT declined. Medicaid spending on osteoporosis therapy also changed dramatically during the last decade, as yearly expenditure increased 664% from 1465 US dollars to 9742 US dollars per 1000 beneficiaries. Over this period, a significant shift from daily to weekly bisphosphonates also occurred. CONCLUSIONS: A dramatic decline in HRT and continued rise in bisphosphonate prescribing has occurred since the publication of the WHI. During this time, there have also been substantial increases in osteoporosis medication spending within Medicaid. Determining whether these trends are clinically appropriate and cost effective for osteoporosis therapy will have important implications for the development of future drug reimbursement programs, especially for elderly patients.

Calcitonin↗
PubMed2001

Quantitative ultrasound and bone mineral density are equally strongly associated with risk factors for osteoporosis.

Because resources do not allow all women to be screened for osteoporosis, clinical risk factors are often used to identify those individuals at increased risk of fracture who are then assessed by bone densitometry. The aim of this study was to compare calcaneal quantitative ultrasound (QUS) and axial bone mineral density (BMD) T and Z scores in a large group of women, some with no clinical risk factors and others with one or more risk factors for osteoporosis. The study population consisted of 1115 pre- and postmenopausal women. A subgroup of 530 women was used to construct reference data for calculating T and Z scores. A total of 786 women was found to have one or more of the following risk factors: (i) atraumatic fracture since the age of 25 years, (ii) report of X-ray osteopenia, (iii) predisposing medical condition or use of therapy known to affect bone metabolism, (iv) premature menopause before the age of 45 years or a history of amenorrhea of longer than 6 months duration, (v) family history of osteoporosis, (vi) body mass index (BMI) <20 kg/m2, and (vii) current smoking habit. Calcaneal broadband ultrasound attenuation (BUA) and speed of sound (SOS) measurements were performed on a Hologic Sahara and a DTUone and BMD was measured at the spine and hip using dual-energy X-ray absorptiometry (DXA). The Z score decrements associated with the seven risk factors calculated using multivariate regression analysis were similar for QUS and BMD measurements. Z score decrements (mean of BMD and QUS measurements combined) associated with a history of atraumatic fracture (-0.67), X-ray osteopenia (-0.36), a family history of osteoporosis (-0.23), and a low BMI (-0.53) were all statistically significant compared with women with no risk factors. Z score decrements associated with a medical condition or use of therapy known to affect bone metabolism, a premature menopause or prolonged amenorrhea, or those who were current smokers were not significantly different from zero. As the number of risk factors present in each individual increased, the mean Z score decrements became more negative, increasing from -0.28 for women with one risk factor to -1.19 for those with four or more risk factors. QUS and BMD measurements yielded similar mean Z scores for women with one, two, three, or more than four risk factors. Using the World Health Organization (WHO) criteria to diagnose osteoporosis for BMD measurements and revised diagnostic criteria for QUS, approximately one-third of postmenopausal women aged 50+ years with clinical risk factors were classified as osteoporotic compared with only 12% of women without clinical risk factors. Over two-thirds of postmenopausal women with risk factors were classified as osteopenic or osteoporotic and approximately 28% were classified as normal. The proportion of women classified into each diagnostic category was similar for BMD and QUS. In conclusion, clinical risk factors for osteoporosis affected calcaneal BUA and SOS Z score measurements to the same extent as axial BMD Z score measurements. Provided revised diagnostic criteria are adopted for QUS, similar proportions of postmenopausal women are identified as osteopenic or osteoporotic as with BMD.

Absorptiometry, Photon↗
PubMed2003

The Food and Drug Administration's Osteoporosis Guidance Document: past, present, and future.

In December 1979, the Food and Drug Administration's (FDA) Division of Metabolic and Endocrine Drug Products issued its Guidelines for the Clinical Evaluation of Drugs Used in the Treatment of Osteoporosis. The Guidance Document recommended study designs, patient populations for study, and techniques for evaluating skeletal mass and fracture frequency that were considered central to showing the efficacy and safety of drugs used to treat and prevent postmenopausal osteoporosis (PMO). In this paper, I discuss the evolution of the Osteoporosis Guidance as it relates to the pharmaceutical industry's efforts to develop effective and safe anti-osteoporosis drugs. Current regulatory policy on osteoporosis drugs and thoughts on the future direction of the Osteoporosis Guidance are also provided.

Female↗
PubMed2005

Assessment of vitamin D status in male osteoporosis.

BACKGROUND: Clinical assessment of vitamin D status often relies on measuring total circulating 25-hydroxyvitamin D3 (25OHD3), but much of each vitamin D metabolite is bound to plasma vitamin D-binding protein (DBP), such that the percentage of free vitamin is very low. We hypothesized that measurement of free rather than total 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] and 25OHD3 may provide better assessment of vitamin D status. We therefore aimed to assess vitamin D status in men with idiopathic osteoporosis, in whom possible secondary causes of osteoporosis had been excluded, and to determine the extent of change in biologically active "free" vitamin D caused by variation in plasma DBP concentrations. METHODS: We measured 1,25(OH)2D3 and 25OHD3 in plasma samples from 56 men with idiopathic osteoporosis [mean (SD) age, 59.6 (13.6) years; range, 21-86 years] and 114 male controls [62.4 (10.4) years; range, 44-82 years]. RESULTS: Mean total plasma 25OHD3 in the 56 men with osteoporosis and the 114 controls was 44.7 (21) and 43.3 (17) nmol/L, respectively; total plasma 1,25(OH)2D3 measured in randomly selected men with osteoporosis (n = 50) and controls (n = 50) was 90 (37) and 103 (39) pmol/L, respectively. Mean plasma DBP was significantly higher (P <0.001) in men with osteoporosis [224 (62) mg/L; n = 56] than in the controls [143 (34) mg/L; n = 114], but calculated free plasma 25OHD3 and 1,25(OH)2D3 were significantly lower in the osteoporotic men than in controls [6.1 (3.1) vs 9.1 (4.4) pmol/L (P <0.00001) and 77 (37) vs 142 (58) fmol/L (P <0.00001), respectively]. CONCLUSIONS: Measurement of total vitamin D metabolites alone, although providing a crude assessment of vitamin D status, may not give an accurate indication of the free (biologically active) form of the vitamin. The ratio of total 25OHD3 and 1,25(OH)2D3 to plasma DBP, rather than total circulating vitamin D metabolites, may provide a more useful index of biological activity. Further studies are required to substantiate this hypothesis.

Absorptiometry, Photon↗
PubMed1996

Severe osteoporosis before and after lung transplantation.

STUDY OBJECTIVE: Osteoporosis and/or fractures have been reported as a complication of kidney, heart, liver, bone marrow, and, most recently, lung transplantation (LTx). We measured bone mineral density (BMD) before and after LTx to determine the frequency and severity of preoperative and postoperative osteoporosis. PATIENTS AND METHODS: We conducted a cross-sectional study of BMD in 100 patients with various diagnoses before (n = 55) and after (n = 45) LTx. RESULTS: Age-matched mean spine and femoral BMDs were severely depressed before and after LTx placing 45% of the pre-LTx and 73% of the post-LTx patients at or below the fracture threshold (2 SDs below the mean). As expected, patients with cystic fibrosis had lower (p < 0.05) mean spine and femoral BMD than patients with COPD or other lung diseases both before and after LTx. Nevertheless, considerable osteoporosis was present in the patients with COPD and other lung diseases before and after LTx. The best predictors of pre- and post-LTxZ scores were body mass index (r = 0.56 to 0.59, p < 0.001) and cumulative steroid dose/per kilogram (r = 0.49-0.51, p < 0.001), respectively. Osteoporosis has resulted in 3 symptomatic fractures before and 12 after LTx. CONCLUSIONS: Osteoporosis appears to be widespread in patients with end-stage respiratory failure before LTx and LTx, while often life-saving, has an adverse impact on BMD. As patients live longer after LTx, osteoporosis-related fractures may compromise quality of life by causing pain and debilitation.

Adolescent↗
PubMed2004

Osteoporosis and cardiovascular disease: brittle bones and boned arteries, is there a link?

Both osteoporosis and cardiovascular disease (CVD) are major public health problems leading to increased morbidity and mortality. Although traditionally viewed as separate disease entities that increase in prevalence with aging, accumulating evidence indicates that there are similar pathophysiological mechanisms underlying both diseases. In addition to menopause and advanced age, other risk factors for CVD such as dyslipidemia, oxidative stress, inflammation, hyperhomocystinemia, hypertension, and diabetes have also been associated with increased risk of low bone mineral density (LBMD). Elevated LDL and low HDL cholesterol are associated with LBMD, altered lipid metabolism is associated with both bone remodeling and the atherosclerotic process, which might explain, in part, the co-existence of osteoporosis and atherosclerosis in patients with dyslipidemia. Similarly, inflammation plays a pivotal role in both atherosclerosis and osteoporosis. Elevated plasma homocysteine levels are associated with both CVD and osteoporosis. Nitric oxide (NO), in addition to its known atheroprotective effects, appears to also play a role in osteoblast function and bone turnover. Supporting this notion, in a small randomized controlled trial, nitroglycerine (an NO donor) was found to be as effective as estrogen in preventing bone loss in women with surgical menopause. Statins, agents that reduce atherogenesis, also stimulate bone formation. Furthermore, bis- phosphonates, used in the treatment of osteoporosis, have been shown to inhibit atherogenesis. Intravenous bisphosphonate therapy significantly decreases serum LDL and increases HDL in postmenopausal women The exciting possibilities of newer pharmacological agents that effectively treat both osteoporosis and CVD hold considerable promise. However, it is important to emphasize that the current evidence linking both of these diseases is far from conclusive. Therefore, additional research is necessary to further characterize the relationship between these two common illnesses.

Cardiovascular Diseases↗
PubMed2002

Densitometric diagnosis of osteoporosis in men: effect of measurement site and normative database.

Controversy exists regarding which sites to measure, and the appropriate reference database to use, for densitometric diagnosis of osteoporosis in men. While hip and spine bone mineral density (BMD) measurement is routine, spinal osteoarthritis often elevates measured BMD in older men. Additionally, the use of male reference data is standard practice; however, recent reports suggest that a female database may be more appropriate. This study evaluated the effect of sites measured, and normative database utilized, on the densitometric diagnosis of osteoporosis in men. Spine, femur, and ultradistal radial BMD T-scores were determined in 595 male veterans using the GE Lunar male normative database. Subsequently, World Health Organization diagnostic criteria were applied, identifying 282 men with osteoporosis (T-score </= 2.5). The combination of femoral (lowest of neck or total) with the ultradistal radius site was more sensitive (p < 0.0001) for diagnosing osteoporosis than femur plus lumbar spine. When scans from 129 subjects with documented fractures were analyzed using female normative data, fewer (p < 0.0001) met an arbitrary threshold for receiving pharmacologic osteoporosis therapy. In conclusion, BMD measurement at only the spine and hip leads to underdiagnosis of osteoporosis in men. This situation will be exacerbated by utilization of a female normative database; more men with prior fracture may be categorized as not meeting a pharmaceutical intervention threshold.

Absorptiometry, Photon↗
PubMed2003

Evaluation of calcaneal quantitative ultrasound in a primary care setting as a screening tool for osteoporosis in postmenopausal women.

Screening of osteoporosis by quantitative ultrasound (QUS) has become widely available in Europe, but no clear strategies for its clinical use have been established. The aim of this study was to validate the use of QUS in a cross-sectional study carried out in three primary care centers. Measurements of calcaneal QUS and bone mineral density (BMD) at proximal femur were obtained by dual-energy X-ray absorptiometry (DXA). Osteoporosis was diagnosed by DXA T-score <or= -2.5 at the femoral neck. Sensitivity, specificity, kappa index, and receives operator characteristics (ROC) curve QUS values were calculated with respect to the standard reference. Both positive and negative likelihood ratios (LR) were used to calculate the optimum cut-off levels. Two hundred and sixty-seven women aged 65 or older were included. Fifty-five percent had osteoporotic femoral neck BMD values (T-score <or= -2.5). The same threshold for QUS yielded a lower prevalence of osteoporosis (10%). Women with BMD diagnosis of osteoporosis were older and showed lower age-adjusted values for all QUS parameters (p < 0.001). Area under the curve (AUC) ranged from 0.662-0.678 for the different QUS parameters; correlation and concordance of all parameters with femoral neck BMD were statistically significant (p < 0.001). Cut-off values calculated from the AUC yielded 61.1% sensitivity and 65.3% specificity for the best QUS parameter (i.e., Estimated Heel T-score <or= -1.55). Estimated Heel T-score values of +0.05 or above ruled out osteoporosis (LR 0.18), whereas those -2.50 or below supported the diagnosis (LR 5.98). The application of these cutoff points allowed classification of 22.1% of cases. In conclusion, in postmenopausal women, QUS screening conclusively confirms or rules out osteoporosis in approximately one-fifth of cases, thereby avoiding the need for a DXA measurement.

Aged↗
PubMed2004

Evaluation of an osteoporosis self-referral program to enhance management outcomes.

Osteoporosis is a common but undertreated condition. While bone density is known to predict fracture risk, there is currently no economical way of measuring general population risk. This study examined whether an economical screening technique could improve diagnosis and lead to appropriate outcomes in the management of osteoporosis. A self-referral program was established to provide women with information about osteoporosis and an individualized risk assignment. A high-risk designation was provided for postmenopausal women below the lower tertile of a calcaneal broadband ultrasound attenuation (BUA) (< or = 58 db/MHz) or those with a SCORE value > or = 6. A telephone survey was conducted 6 mo after program registration to evaluate osteoporosis management outcomes. Of 271 women surveyed, 181 (67%) were postmenopausal and thus potential candidates for estrogen replacement, and 21% and 63% were assigned a high-risk profile by either calcaneal ultrasound or SCORE, respectively. Women at higher risk were significantly more likely to discuss osteoporosis with their family physician (p < 0.001), and to undergo further testing with dual X-ray absorptiometry measurement (p < 0.005). Utilization of estrogen replacement by postmenopausal women at time of survey was significantly increased compared to registration (p = 0.01). The self-referral program positively impacted decisions women made about preventing osteoporosis, particularly if they considered themselves at higher risk.

Absorptiometry, Photon↗
PubMed2004

Osteoporosis prevalence in men varies by the normative reference.

Controversy surrounds which normative data should be used to estimate osteoporosis prevalence in men. Prevalence estimates may vary significantly when different normative standards are applied. Five normative datasets (NHANES female norms, local female norms, Hologic densitometer manufacturer female norms, NHANES male norms, Hologic male norms) were used to estimate the prevalence of osteoporosis by World Health Organization diagnostic criteria in a study population of 311 consecutive men between the age of 30 and 91 (mean 60.3 yr) referred to an outpatient osteoporosis center between January 1996 and December 1998. Statistically significant variations were seen in osteoporosis prevalence measured at three anatomical sites. The greatest relative variation was seen for the total femur, where osteoporosis prevalence ranged from 7.0% (NHANES and Hologic female norms) to 15.6% (NHANES male norms). The least relative variation was seen at the lumbar spine, where prevalence ranged from 18.1% (Hologic female norms) to 29.6% (local female norms). When considering osteoporosis at any site, prevalence was lowest (23.5%) based on Hologic female norms and highest (35.8%) based on local female norms. Interpretation of prevalence data should include an assessment of how normative standards influence reporting of the population at high risk of fracture.

Adult↗
PubMed2002

Asian and Asian-American college students' awareness of osteoporosis.

STUDY OBJECTIVE: To quantify Asian and Asian-American college students' knowledge of osteoporosis and preventive health behaviors. DESIGN: Sixty-four-question survey SETTING: University of Minnesota. SUBJECTS: One hundred sixty-eight male and female Asian and Asian-American students, mean age 21 +/- 3.4 years. MAIN RESULTS: About half of the students consumed 0-1 servings/day of dietary calcium, 42% consumed 2 cups/day or more of caffeinated beverages, 8% smoked cigarettes, and 61% exercised 2.5 hours/week or less. At least 1 serving/day of phytoestrogen was consumed by 80% of the students. Only 11% of students answered at least 75% of osteoporosis fact questions correctly. Women (p = 0.011) and the United States-born participants (p = 0.006) were more apt to change their health behaviors to prevent or treat osteoporosis than men and Asia-born participants. Thirty-eight percent of Hmong participants attributed osteoporosis to fate, chance, or luck whereas Vietnamese participants were more likely to attribute osteoporosis to diet. Most participants (63%) did not know whether their culture objected to estrogen replacement therapy, and 42% said menopause was a natural occurrence for which pharmacologic treatment should not be administered. CONCLUSIONS: Many Asian and Asian-American college students did not practice health behaviors to prevent osteoporosis, and most lacked sufficient knowledge about the condition.

Adult↗
PubMed2006

Ibandronate, an experimental intravenous bisphosphonate for osteoporosis, bone metastases, and hypercalcemia of malignancy.

Ibandronate is an experimental intravenous bisphosphonate under study for the prevention or treatment of osteoporosis and skeletal complications of bone metastases, as well as hypercalcemia of malignancy. To review the data on this drug, PubMed/MEDLINE was searched for pertinent studies in English; data from January 1986-October 2005 were reviewed. In preclinical studies, ibandronate was an extremely potent bisphosphonate compared with its predecessors and was active in all animal models of human postmenopausal and corticosteroid-associated osteoporosis. Similar to other bisphosphonates, ibandronate exhibits antitumor activity and prevents or reduces bone metastases. Forty to fifty percent of the dose is bound to bone; renal clearance of unchanged drug accounts for 70% of total body clearance. Early clinical trials demonstrated efficacy and tolerability of intravenous ibandronate in the prevention or treatment of postmenopausal and corticosteroid-associated osteoporosis when administered once every 3 months. Intravenous ibandronate also reduces skeletal complications of bone metastases, including pain, although the cumulative dose used is much higher than that used in osteoporosis, as the drug is administered every 3-4 weeks. Single doses of intravenous ibandronate are probably also effective in the treatment of hypercalcemia of malignancy. The major tolerability issue with intravenous bisphosphonates is renal safety, thus the drugs generally require infusion (e.g., 0.25 hr for zoledronic acid, 2-24 hrs for pamidronate). However, intravenous ibandronate can be administered by bolus injection over a few minutes without an elevated risk of nephrotoxicity. The experimental intravenous dosage is 2 mg every 3 months for treatment or prevention of osteoporosis, and 2-6 mg every 3-4 weeks or in a single dose for treatment of bone metastases or hypercalcemia of malignancy, respectively. Ibandronate can be used in the presence of severe renal impairment with proper dosage adjustment. The drug will be an interesting addition to the available drugs for osteoporosis, bone metastases, and hypercalcemia of malignancy. Studies of intravenous ibandronate as an adjunctive treatment for cancers that tend to metastasize to bone are under way. Whether intravenous ibandronate will be a therapeutic advance is best answered by randomized, controlled trials. These are ongoing and should provide data with which to make better-informed choices concerning intravenous bisphosphonates.

Bone Density Conservation Agents↗
PubMed2007

Effect of proximal femoral osteoporosis on cementless hip arthroplasty: a short-term clinical analysis.

OBJECTIVE: The aim of this retrospective investigation was to explore the influence of femoral osteoporosis on short-term curative effects of cementless hip arthroplasty and to evaluate the femoral metaphyseal bone mineral density (BMD) for femoral osteoporosis in order to guide prosthesis choice and rehabilitation. METHODS: We performed 127 total arthroplasty operations between June 1999 to February 2003 and investigated 49 cementless hip replacements with the Metalcancellous cementless Lubeck II system being used in all hips. There were twenty men and twenty-nine women whose mean age at the time of the operation was 60 years (range, 52~81 years). The patients were divided into osteoporosis or normal groups according to the femoral metaphyseal BMD measured preoperatively. The average duration of follow-up was 30 months (range, 8~52 months). We evaluated all of the patients from a clinical standpoint with use of a standard-terminology questionnaire with respect to the short-term curative effects and patients' satisfaction. Hip pain status and functional ability were important indicators of treatment efficacy. RESULTS: Harris hip score and patients' satisfaction in femoral osteoporosis patients who underwent noncemented hip arthroplasty were lower (P=0.004, P=0.03) while the incidence of thigh pain was higher (P=0.03) than the patients with non-osteoporosis. CONCLUSION: The higher incidence of pain, as well as the decrease in function experienced by the patients in osteoporosis group, supports the case that cementless arthroplasty is not a better choice for those patients and that we had better select prosthesis based on the femoral metaphyseal BMD.

Aged↗
PubMed1996

Intranasal salcatonin (salmon calcitonin). A review of its pharmacological properties and role in the management of postmenopausal osteoporosis.

Osteoporosis is a common problem among postmenopausal women and is associated with significant morbidity, mortality and costs primarily resulting from osteoporotic fractures. Salcatonin (salmon calcitonin) inhibits osteoclastic bone resorption and is approximately 40 to 50 times more potent than human calcitonin. In most randomised trials in which intranasal salcatonin (usually 50 to 200 IU/day plus oral calcium supplements) was administered for 1 to 5 years to postmenopausal women for prevention of osteoporosis, bone mineral density or content of the lumbar spine increased by approximately 1 to 3% from baseline. In contrast, postmenopausal women receiving only oral calcium supplements typically had reductions in bone mineral density or content of about 3 to 6%. The difference between treatment groups was statistically significant in essentially all studies. Although changes in bone mineral density or content were broadly similar in studies of postmenopausal women with established osteoporosis to those in postmenopausal women receiving therapy for prevention of the disease, studies in women with established osteoporosis did not usually demonstrate statistically significant differences between treatment groups. Also in postmenopausal women with established osteoporosis, intranasal salcatonin reduced pain and/or analgesic consumption in some trials and, in a limited number of studies of relatively short duration (i.e. < or = 2 years), the incidence of osteoporotic fractures. A large multicentre 5-year study with adequate statistical power to confirm the effect of intranasal salcatonin on reducing osteoporotic fracture rates in postmenopausal women is currently under way. The intranasal formulation of salcatonin offers a more convenient and better tolerated alternative to the parenteral formulation of the drug which is administered by regular subcutaneous or intramuscular injections. Adverse events associated with the intranasal formulation are generally mild and transient, usually involving local reactions such as nasal discomfort, rhinorrhoea or rhinitis. Thus, for postmenopausal women unable or unwilling to tolerate long term hormone replacement therapy, intranasal salcatonin is an attractive alternative for the management of osteoporosis.

Administration, Intranasal↗
PubMed2006

Treating osteoporosis with bisphosphonates and addressing adherence: a review of oral ibandronate.

Osteoporosis is a common, chronic condition, affecting approximately half of all postmenopausal Caucasian women in the US. Vertebral fractures occur as a result of osteoporosis and lead to increased hospitalisation and mortality, and adversely affect patient quality of life. The burden of osteoporosis on healthcare systems is expected to rise as the elderly population continues to grow. Yet there are many medications for preventing and treating osteoporosis. Oral bisphosphonates are first-line treatment for osteoporosis, with demonstrated efficacy in increasing bone mineral density and reducing bone turnover, which reduces the incidence of fractures. However, adherence to medication is suboptimal, with approximately 40% of patients discontinuing treatment within 6 months. Recent reports have suggested simplifying the dosage regimen as a strategy to help address this issue. Ibandronate is a potent, nitrogen-containing bisphosphonate which is administered once-monthly. Preclinical studies initially revealed the feasibility of extending the between-dose interval. Subsequent clinical studies have provided further evidence of the positive effects of extended-interval ibandronate administration in reducing the risk of vertebral fractures through increasing bone mineral density and reducing bone turnover without compromising bone quality. These studies have also demonstrated that ibandronate has a safety profile similar to placebo. Ibandronate has recently been approved for use in the US to treat postmenopausal osteoporosis. This review summarises the efficacy and safety of once-monthly oral ibandronate and discusses the implications of such a treatment in primary care in the US.

Administration, Oral↗
PubMed2001

Candidate genes for osteoporosis. Therapeutic implications.

Osteoporosis, which afflicts 10 million Americans, is a complex disease characterized by decreased bone mass, microarchitectural deterioration of bone tissue, and an increase in fracture risk. Family and twin studies have established a genetic contribution to the etiology of osteoporosis. The biological candidate genes of osteoporosis can be ordered into 5 categories: (i) calcium homeostasis; (ii) hormonal dysfunction; (iii) osteoblast and osteoclast development and regulation; (vi) cartilage matrix metabolism; and (v) lipoprotein metabolism. In addition, genome-wide scans have identified a number of chromosomal regions harboring genes that influence bone mineral density. Moreover, the drug responses to various treatments of osteoporosis are reported to be modulated by DNA polymorphisms of the vitamin D receptor gene, the estrogen receptor 1 gene, and the transforming growth factor beta 1 gene. With the rapid advancement of the Human Genome Project and biotechnology, it will be possible to carry out parallel analyses of large numbers of candidate genes for osteoporosis and to calculate a patient's individual fracture risk in the context of specific environmental influences. This will eventually lead to more advanced diagnostic methods and more efficacious drugs targeting osteoporosis.

Animals↗
PubMed2001

Parathyroid hormone: an anabolic treatment for osteoporosis.

Osteoporosis is a disease characterised by low bone mass, structural deterioration of bone and increased risk of fracture. The prevalence, and cost, of osteoporosis is increasing dramatically with our ageing population and the World Health Organization now considers it to be the second-leading healthcare problem. All currently approved therapies for osteoporosis (eg., estrogen, bisphosphonates, calcitonin and selective estrogen receptor modulators) are anti-resorptive agents that act on osteoclasts to prevent further bone loss. A new class of bone anabolic agent capable of building mechanically strong new bone in patients with established osteoporosis is in development. While the parathyroid hormone (PTH) is classically considered to be a bone catabolic agent, when delivered intermittently at low doses PTH potently stimulates cortical and trabecular bone growth in animals humans. The native hPTH-(1-84) and its osteogenic fragment, hPTH-(1-34), have already entered Phase III clinical trials. Understanding the mechanism of PTH's osteogenic actions has led to the development of smaller PTH analogues which can also build mechanically normal bone in osteopenic rats. These new PTH analogues are promising candidates for treating osteoporosis in humans as they are as efficacious as hPTH-(1-84) and hPTH-(1-34), but there is evidence that they may have considerably less ability to induce hypercalcemia, the major side effect of PTH therapy. In addition to treating osteoporosis, PTHs may be used to promote fracture healing, to restore bone loss in immobilized patients, or following excessive glucocorticoid or prolonged spaceflight, and to treat psoriasis.

Animals↗