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BACKGROUND: With the onset of the COVID-19 pandemic, physicians have had concerns related to the impact of the pandemic on their practice of medicine. Our objective was to evaluate physician questions and concerns related to the COVID-19 pandemic by studying physician calls made to a medico-legal telephone helpline, and explore associations between the pattern of these calls and the temporal progression of the pandemic. METHODS: We conducted a descriptive study of calls related to the COVID-19 pandemic to the Canadian Medical Protective Association (CMPA) from Jan. 1, 2020, to June 30, 2021. Using content analysis, we classified calls into themes. Using a Poisson regression model, we tested for associations between the weekly numbers of physician calls related to COVID-19 and national rates of COVID-19 cases and deaths. RESULTS: We analyzed 3810 COVID-19-related calls. The highest call volume was observed during the pandemic's early months and was widely distributed across the country. Call volume correlated with rates of SARS-CoV-2 infection during the pandemic's first wave (p = 0.002) but not across the entire study period. Call themes included virtual care (826 calls), the pandemic's effect on health care (1160 calls) and challenging patient interactions (1091 calls). INTERPRETATION: We observed high volumes of physician calls to a medico-legal helpline during the first 18 months of the COVID-19 pandemic in Canada. Our data provide insight into the questions and concerns of Canadian physicians, and serve as a contemporaneous account of the adaptability and resilience of physicians during this challenging time.

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We conducted a series of focus groups to explore the information needs of clinicians and consumers related to arthritis and driving. An open coding analysis identified common themes across both consumer and clinician-based focus groups that underscored the importance of addressing driving-related concerns and the challenges associated with assessing safety. The results revealed that although driving is critical for maintaining independence and community mobility, drivers with arthritis experience several problems that can affect safe operation of a motor vehicle. Findings from this study are part of a broader research initiative that will inform the development of the Arthritis and Driving toolkit. This toolkit outlines strategies to support safe mobility for people with arthritis and will be an important resource in the coming years given the aging population.

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BACKGROUND: Elderly nursing home residents are at increased risk of hip fracture; however, the efficacy of fracture prevention strategies in this population is unclear. OBJECTIVE: We performed a scoping review of randomized controlled trials of interventions tested in the long-term care (LTC) setting, examining hip fracture outcomes. METHODS: We searched for citations in 6 respective electronic searches, supplemented by hand searches. Two reviewers independently reviewed all citations and full-text papers; consensus was achieved on final inclusion. Data was abstracted in duplicate. FINDINGS: We reviewed 22,349 abstracts or citations and 949 full-text papers. Data from 20 trials were included: 7--vitamin D (n = 12,875 participants), 2--sunlight exposure (n = 522), 1--alendronate (n = 327), 1--fluoride (n = 460), 4--exercise or multimodal interventions (n = 8,165), and 5--hip protectors (n = 2,594). Vitamin D, particularly vitamin D(3) > or = 800 IU orally daily, reduced hip fracture risk. Hip protectors reduced hip fractures in included studies, although a recent large study not meeting inclusion criteria was negative. Fluoride and sunlight exposure did not significantly reduce hip fractures. Falls were reduced in three studies of exercise or multimodal interventions, with one study suggesting reduced hip fractures in a secondary analysis. A staff education and risk assessment strategy did not significantly reduce falls or hip fractures. In a study underpowered for fracture outcomes, alendronate did not significantly reduce hip fractures in LTC. CONCLUSIONS: The intervention with the strongest evidence for reduction of hip fractures in LTC is Vitamin D supplementation; more research on other interventions is needed.

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OBJECTIVE: In the BONE study (3 years' duration), daily oral ibandronate 2.5 mg reduced vertebral fracture risk by 62% (vs. placebo; p = 0.0001). In the DIVA study (2 years' duration), i.v. ibandronate 2 mg every 2 months (q2mo) or 3 mg every 3 months (q3mo) was superior to daily oral ibandronate in terms of BMD gains (p < 0.001) and normalisation of bone turnover markers, suggesting potential antifracture efficacy with the licensed i.v. regimen (3 mg q3mo). To evaluate this, a post-hoc analysis of non-vertebral fracture incidence was performed using DIVA study individual patient data. METHODS: Both i.v. doses had the same annual cumulative exposure (ACE) - 12 mg. Therefore, data for these two regimens were pooled. This higher dose was compared with 2.5 mg daily oral ibandronate (ACE 5.5 mg) to maintain trial randomisation. Osteoporotic non-vertebral fractures were captured as a secondary endpoint. Time-to-event analysis was conducted using Kaplan-Meier methodology; hazard ratios (HRs) were derived from a Cox model with adjustments for clinical fracture, age and BMD. The DIVA trial was not primarily designed to assess fracture efficacy. RESULTS: The rate of non-vertebral fractures was significantly reduced when ibandronate ACE 12 mg (3 mg q3mo and 2 mg q2mo i.v.) was compared with ACE 5.5 mg (2.5 mg daily oral). The non-vertebral fracture incidence was 3.1% versus 4.8%, respectively, representing a 43% relative risk reduction with i.v. ibandronate (p = 0.0489; adjusted HR 0.569 [95% confidence interval: 0.324, 0.997]). Time to non-vertebral fracture was also extended for high- versus low-dose ibandronate (p = 0.048). CONCLUSIONS: A significant effect on non-vertebral fracture risk reduction was seen when high i.v. ibandronate doses were compared with a lower oral dose. This post-hoc analysis indicates greater antifracture efficacy for the licensed quarterly i.v. regimen versus daily oral dosing.

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BACKGROUND: Many residents of the United States and Canada depend on dietary sources of vitamin D to help maintain vitamin D status. Because few natural food sources contain vitamin D, fortified foods may be required. OBJECTIVE: We aimed to determine the effects of vitamin D-fortified foods on serum 25-hydroxyvitamin D [25(OH)D] concentrations. DESIGN: We searched MEDLINE (1966 to June Week 3 2006), Embase, CINAHL, AMED, Biological Abstracts, and the Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) comparing vitamin D-fortified foods with a control and reporting serum 25(OH)D concentrations. Two reviewers independently determined study eligibility, assessed trial quality, and extracted relevant data. Disagreements were resolved by consensus. Meta-analyses of absolute mean change in 25(OH)D were conducted by using a random-effects model, with evaluation of heterogeneity. RESULTS: Nine RCTs (n = 889 subjects) were included, of which 8 consistently showed a significant beneficial effect of food fortification on 25(OH)D concentrations. Although 7 RCTs (n = 585 subjects) potentially were meta-analyzable, we were unable to combine the overall results because of significant heterogeneity. The individual treatment effects ranged from 14.5 (95% CIs: 10.6, 18.4) nmol/L to 34.5 (17.64, 51.36) nmol/L (3.4-25 microg vitamin D/d). Subgroup analyses showed a reduction in heterogeneity and significant treatment effect when 4 trials that used milk as the fortified food source were combined. CONCLUSION: Most trials were small in size and inadequately reported allocation concealment, but results showed that vitamin D-fortified foods improved vitamin D status in adults.

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Our objective was to conduct a systematic review on the benefits and harms of calcitriol and alfacalcidol in the reduction of fracture and fall risk. Randomized controlled trials (RCTs) comparing these agents to placebo or calcium and reporting fracture and fall incidence were retrieved from MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Two reviewers independently determined study eligibility, assessed trial quality, and extracted data. Twenty-three RCTs were included (2139 participants), and 16 trials had sufficient data for meta-analysis. Vertebral fractures were not significantly reduced based on the combined results of 13 trials; however, subgroup analyses demonstrated a significant reduction with alfacalcidol [odds ratio (OR) = 0.50, 95% confidence interval (CI), 0.25-0.98], but not with calcitriol. There was a significant reduction in nonvertebral fractures (six trials, OR = 0.51, 95% CI, 0.30-0.88), and falls (two trials, OR = 0.66, 95% CI, 0.44-0.98). There was an increased risk of hypercalcemia (OR = 3.63, 95% CI, 1.51-8.73) and a trend toward an increased risk of hypercalciuria. There is evidence to suggest that these agents may reduce the incidence of nonvertebral fractures and falls; however, their benefit on vertebral fracture reduction may depend on the type of active vitamin D. Hypercalcemia and hypercalciuria are potential side effects.

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Gastroenterology is full of examples of drugs being enthusiastically promoted only to be withdrawn or prescription curtailed once the harms of the medication are realized. Cox-2 inhibitors, alosetron, and tegaserod are all recent examples of this phenomenon. The problem is that potential harms of drugs are being highlighted in the medical literature all the time and it can be difficult to determine whether these represent a genuine risk to our patients or are just spurious epidemiological associations. The association between proton pump inhibitor therapy and hip fracture is a good illustration of this dilemma. We use this example to highlight an approach that can be taken to critically evaluate the evidence for harms of medication.

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The objective of this evidence review was to synthesize the literature on the effectiveness and safety of nutritional and ultraviolet radiation sources of vitamin D with respect to bone health outcomes at all stages of life. The goals were to identify knowledge gaps for the research community and to highlight areas that required further research. We completed an extensive literature search of multiple databases and a multilevel selection process with synthesis of results from 167 included studies. We included a variety of outcomes (eg, falls, bone mineral density, fractures, and adverse events). This report provides an overview of the methods and a summary of the key findings. In addition, we discuss areas where the evidence is inconclusive, as well as methodologic issues that we encountered. We found inconsistent evidence of an association between serum 25-hydroxyvitamin D [25(OH)D] concentration and bone mineral content in infants and fair evidence of an association with bone mineral content or density in older children and older adults. The evidence of an association between serum 25(OH)D concentration and some clinical outcomes (fractures, performance measures) in postmenopausal women and older men was inconsistent, and the evidence of an association with falls was fair. We found good evidence of a positive effect of consuming vitamin D-fortified foods on 25(OH)D concentrations. The evidence for a benefit of vitamin D on falls and fractures varied. We found fair evidence that adults tolerated vitamin D at doses above current dietary reference intake levels, but we had no data on the association between long-term harms and higher doses of vitamin D.

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BACKGROUND: To evaluate factors associated with whether patients associate their fracture with future fracture risk. METHODS: Fragility fracture patients participated in a telephone interview. Unadjusted odds ratios (OR, [95% CI]) were calculated to identify factors associated with whether patients associate their fracture with increased fracture risk or osteoporosis. Predictors identified in univariate analysis were entered into multivariable logistic regression models. RESULTS: 127 fragility fracture patients (82% female) participated in the study, mean (SD) age 67.5 (12.7) years. An osteoporosis diagnosis was reported in 56 (44%) participants, but only 17% thought their fracture was related to osteoporosis. Less than 50% perceived themselves at increased risk of fracture. The odds of an individual perceiving themselves at increased risk for fracture were higher for those that reported a diagnosis of osteoporosis (OR 22.91 [95%CI 7.45;70.44], p < 0.001), but the odds decreased with increasing age (0.95 [0.91;0.99], p<0.009). The only variable significantly associated with the perception that the fracture was related to osteoporosis was self-reported osteoporosis diagnosis (39.83 [8.15;194.71], p<0.001). CONCLUSION: Many fragility fracture patients do not associate their fracture with osteoporosis. It is crucial for physicians to communicate to patients that an osteoporosis diagnosis, increasing age or a fragility fracture increases the risk for future fracture.

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OBJECTIVES: To review and synthesize the literature in the following areas: the association of specific circulating 25(OH)D concentrations with bone health outcomes in children, women of reproductive age, postmenopausal women and elderly men; the effect of dietary intakes (foods fortified with vitamin D and/or vitamin D supplementation) and sun exposure on serum 25(OH)D; the effect of vitamin D on bone mineral density (BMD) and fracture or fall risk; and the identification of potential harms of vitamin D above current reference intakes. DATA SOURCES: MEDLINE(R) (1966-June Week 3 2006); Embase (2002-2006 Week 25); CINAHL (1982-June Week 4, 2006); AMED (1985 to June 2006); Biological Abstracts (1990-February 2005); and the Cochrane Central Register of Controlled Trials (2nd Quarter 2006). REVIEW METHODS: Two independent reviewers completed a multi-level process of screening the literature to identify eligible studies (title and abstract, followed by full text review, and categorization of study design per key question). To minimize bias, study design was limited to randomized controlled trials (RCTs) wherever possible. Study criteria for question one were broadened to include observational studies due to a paucity of available RCTs, and question four was restricted to systematic reviews to limit scope. Data were abstracted in duplicate and study quality assessed. Differences in opinion were resolved through consensus or adjudication. If clinically relevant and statistically feasible, meta-analyses of RCTs on vitamin D supplementation and bone health outcomes were conducted, with exploration of heterogeneity. When meta-analysis was not feasible, a qualitative systematic review of eligible studies was conducted. RESULTS: 167 studies met our eligibility criteria (112 RCTs, 19 prospective cohorts, 30 case-controls and six before-after studies). The largest body of evidence on vitamin D status and bone health was in older adults with a lack of studies in premenopausal women and infants, children and adolescents. The quality of RCTs was highest in the vitamin D efficacy trials for prevention of falls and/or fractures in older adults. There was fair evidence of an association between low circulating 25(OH)D concentrations and established rickets. However, the specific 25(OH)D concentrations associated with rickets is uncertain, given the lack of studies in populations with dietary calcium intakes similar to North American diets and the different methods used to determine 25(OH)D concentrations. There was inconsistent evidence of an association of circulating 25(OH)D with bone mineral content in infants, and fair evidence that serum 25(OH)D is inversely associated with serum PTH. In adolescents, there was fair evidence for an association between 25(OH)D levels and changes in BMD. There were very few studies in pregnant and lactating women, and insufficient evidence for an association between serum 25(OH)D and changes in BMD during lactation, and fair evidence of an inverse correlation with PTH. In older adults, there was fair evidence that serum 25(OH)D is inversely associated with falls, fair evidence for a positive association with BMD, and inconsistent evidence for an association with fractures. The imprecision of 25(OH)D assays may have contributed to the variable thresholds of 25(OH)D below which the risk of fractures, falls or bone loss was increased. There was good evidence that intakes from vitamin D-fortified foods (11 RCTs) consistently increased serum 25(OH)D in both young and older adults. Eight randomized trials of ultraviolet (UV)-B radiation (artificial and solar exposure) were small and heterogeneous with respect to determination of the exact UV-B dose and 25(OH)D assay but there was a positive effect on serum 25(OH)D concentrations. It was not possible to determine how 25(OH)D levels varied by ethnicity, sunscreen use or latitude. Seventy-four trials examined the effect of vitamin D(3) or D(2) on 25(OH)D concentrations. Most trials used vitamin D(3), and the majority enrolled older adults. In three trials, there was a greater response of serum 25(OH)D concentrations to vitamin D(3) compared to vitamin D(2), which may have been due to more rapid clearance of vitamin D(2) in addition to other mechanisms. Meta-analysis of 16 trials of vitamin D(3) was consistent with a dose-response effect on serum 25(OH)D when comparing daily doses of <400 IU to doses >/= 400 IU. An exploratory analysis of the heterogeneity demonstrated a significant positive association comparable to an increase of 1 - 2 nmol/L in serum 25(OH)D for every 100 additional units of vitamin D although heterogeneity remained after adjusting for dose. Vitamin D(3) in combination with calcium results in small increases in BMD compared to placebo in older adults although quantitative synthesis was limited due to variable treatment durations and BMD sites. The evidence for fracture reduction with vitamin D supplementation was inconsistent across 15 trials. The combined results of trials using vitamin D(3) (700 - 800 IU daily) with calcium (500 - 1,200 mg) was consistent with a benefit on fractures although in a subgroup analysis by setting, benefit was primarily in elderly institutionalized women (fair evidence from two trials). There was inconsistent evidence across 14 RCTs of a benefit on fall risk. However, a subgroup analysis showed a benefit of vitamin D in postmenopausal women, and in trials that used vitamin D(3) plus calcium. In addition, there was a reduction in fall risk with vitamin D when six trials that adequately ascertained falls were combined. Limitations of the fall and fracture trials included poor compliance with vitamin D supplementation, incomplete assessment of vitamin D status and large losses to follow-up. We did not find any systematic reviews that addressed the question on the level of sunlight exposure that is sufficient to maintain serum 25(OH)D concentrations but minimizes risk of melanoma and non-melanoma skin cancer. There is little evidence from existing trials that vitamin D above current reference intakes is harmful. In most trials, reports of hypercalcemia and hypercalciuria were not associated with clinically relevant events. The Women's Health Initiative study did report a small increase in kidney stones in postmenopausal women aged 50 to 79 years whose daily vitamin D(3) intake was 400 IU (the reference intake for 50 to 70 years, and below the reference intake for > 70 years) combined with 1000 mg calcium. The increase in renal stones corresponded to 5.7 events per 10,000 person-years of exposure. The women in this trial had higher calcium intakes than is seen in most post-menopausal women. CONCLUSIONS: The results highlight the need for additional high quality studies in infants, children, premenopausal women, and diverse racial or ethnic groups. There was fair evidence from studies of an association between circulating 25(OH)D concentrations with some bone health outcomes (established rickets, PTH, falls, BMD). However, the evidence for an association was inconsistent for other outcomes (e.g., BMC in infants and fractures in adults). It was difficult to define specific thresholds of circulating 25(OH)D for optimal bone health due to the imprecision of different 25(OH)D assays. Standard reference preparations are needed so that serum 25(OH)D can be accurately and reliably measured, and validated. In most trials, the effects of vitamin D and calcium could not be separated. Vitamin D(3) (>700 IU/day) with calcium supplementation compared to placebo has a small beneficial effect on BMD, and reduces the risk of fractures and falls although benefit may be confined to specific subgroups. Vitamin D intake above current dietary reference intakes was not reported to be associated with an increased risk of adverse events. However, most trials of higher doses of vitamin D were not adequately designed to assess long-term harms.

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BACKGROUND: The study objectives were to determine fracture rates in relation to bone mineral density at various central skeletal sites, using the World Health Organization definition for osteoporosis (T-score -2.5 or less), and to contrast fracture patterns among women 50 to 64 years of age with those among women 65 years of age and older. METHODS: Historical cohort study with a mean observation period of 3.2 (standard deviation [SD] 1.5) years. The study group (16,505 women 50 years of age or older) was drawn from the Manitoba Bone Density Program database, which includes all bone mineral density results for Manitoba. Baseline density measurements for the lumbar spine and hip were performed with dual-energy x-ray absorptiometry. Outcomes included the percentage of osteoporotic fractures and the rates of fracture and excess fracture (per 1000 person-years) among postmenopausal women with osteopenia and osteoporosis relative to those with normal bone mineral density (according to the classification of the World Health Organization). RESULTS: The mean age was 65 (SD 9) years, and the mean T-scores for all sites fell within the osteopenic category. There were 765 incident fractures (fracture rate 14.5 [95% confidence interval, CI, 13.5-15.6 [per 1000 person-years). Fracture rates were significantly higher among women 65 years of age or older than among women 50-64 years of age (21.6 [95% CI 19.7-23.4] v. 8.6 [95% CI 7.5-9.7] per 1000 person-years, p < 0.001). Although fracture rates were significantly higher among women with osteoporotic T-scores, most fractures occurred in women with nonosteoporotic values (min-max: 59.7%-67.8%). INTERPRETATION: In this study, most of the postmenopausal women with osteoporotic fractures had nonosteoporotic bone mineral density values. This finding highlights the importance of considering key clinical risk factors that operate independently of bone mineral density (such as age) when assessing fracture risk.

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BACKGROUND: Decision aids are evidence based tools that assist patients in making informed values-based choices and supplement the patient-clinician interaction. While there is evidence to show that decision aids improve key indicators of patients' decision quality, relatively little is known about physicians' acceptance of decision aids or factors that influence their decision to use them. The purpose of this study was to describe physicians' perceptions of three decision aids, their expressed intent to use them, and their subsequent use of them. METHODS: We conducted a cross-sectional survey of random samples of Canadian respirologists, family physicians, and geriatricians. Three decision aids representing a range of health decisions were evaluated. The survey elicited physicians' opinions on the characteristics of the decision aid and their willingness to use it. Physicians who indicated a strong likelihood of using the decision aid were contacted three months later regarding their actual use of the decision aid. RESULTS: Of the 580 eligible physicians, 47% (n = 270) returned completed questionnaires. More than 85% of the respondents felt the decision aid was well developed and that it presented the essential information for decision making in an understandable, balanced, and unbiased manner. A majority of respondents (>80%) also felt that the decision aid would guide patients in a logical way, preparing them to participate in decision making and to reach a decision. Fewer physicians (<60%) felt the decision aid would improve the quality of patient visits or be easily implemented into practice and very few (27%) felt that the decision aid would save time. Physicians' intentions to use the decision aid were related to their comfort with offering it to patients, the decision aid topic, and the perceived ease of implementing it into practice. While 54% of the surveyed physicians indicated they would use the decision aid, less than a third followed through with this intention. CONCLUSION: Despite strong support for the format, content, and quality of patient decision aids, and physicians' stated intentions to adopt them into clinical practice, most did not use them within three months of completing the survey. There is a wide gap between intention and behaviour. Further research is required to study the determinants of this intention-behaviour gap and to develop interventions aimed at barriers to physicians' use of decision aids.

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OBJECTIVE: To design a Bayesian random effects model for pooling binary outcome data from cluster randomized trials (CRTs) with individually randomized trials (IRTs) and then use this model to determine if hip protectors decrease the risk of hip fracture in elderly nursing home residents. STUDY DESIGN AND SETTING: Eight electronic databases were searched; abstracts and papers were reviewed in duplicate. Randomized controlled trials of hip protectors in nursing homes were included. The pooled mean odds ratio (OR) of a hip fracture in an individual allocated to hip protectors with 95% credibility interval (CRI) was calculated. RESULTS: We included four trials of 1,922 individuals (including three CRTs). The pooled OR of an elderly nursing home resident sustaining one or more hip fractures with hip protector allocation was 0.40 (95% CRI 0.25, 0.61). The model was robust in multiple sensitivity analyses assuming alternative intracluster correlation coefficient values. CONCLUSION: The Bayesian approach may be used in meta-analyses of IRTs and CRTs. Using this approach, we have determined that hip protectors decrease the risk of hip fracture in elderly nursing home residents. Methodologic limitations of the included trials and a possible herd effect in CRTs may have influenced these results.

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The purpose of this study was to characterize the diagnostic process, frequency of associated disorders, family history, and impact of a gluten-free diet in individuals with celiac disease. All members of the Canadian Celiac Association (n=5240) were surveyed with a questionnaire. Respondents included 2681 adults with biopsy-proven celiac disease. The mean age was 56 years. Most common presenting symptoms included abdominal pain (83%), diarrhea (76%), and weight loss (69%). The mean delay in diagnosis was 11.7 years. Diagnoses made prior to celiac disease included anemia (40%), stress (31%), and irritable bowel syndrome (29%). Osteoporosis was common. Prior to diagnosis, 27% of respondents consulted three or more doctors about their symptoms. Delays in diagnosis of celiac disease remain a problem. Associated medical conditions occur frequently. More accurate food labeling is needed. Improved awareness of celiac disease and greater use of serological screening tests may result in earlier diagnosis and reduced risk of associated conditions.

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The authors performed this study to determine the accuracy of several text classification methods to categorize wrist x-ray reports. We randomly sampled 751 textual wrist x-ray reports. Two expert reviewers rated the presence (n = 301) or absence (n = 450) of an acute fracture of wrist. We developed two information retrieval (IR) text classification methods and a machine learning method using a support vector machine (TC-1). In cross-validation on the derivation set (n = 493), TC-1 outperformed the two IR based methods and six benchmark classifiers, including Naive Bayes and a Neural Network. In the validation set (n = 258), TC-1 demonstrated consistent performance with 93.8% accuracy; 95.5% sensitivity; 92.9% specificity; and 87.5% positive predictive value. TC-1 was easy to implement and superior in performance to the other classification methods.

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BACKGROUND: Human parathyroid hormone (hPTH)(1-34) was approved in 2004 for the treatment of severe osteoporosis. Members of the Osteoporosis Canada clinical guidelines committee conducted a systematic review of randomized controlled trials (RCTs) to assess the efficacy and safety of hPTH for fracture prevention in postmenopausal women and men with osteoporosis. METHODS: We searched MEDLINE, EMBASE, HTA, Current Contents and the Cochrane Controlled Trials Registry for published data from 1966 to February 2005. A systematic literature search for RCTs was conducted using the Cochrane Collaborative approach. We identified 12 trials that randomly assigned patients either to hPTH or placebo or to hPTH or an active comparator and were at least 1 year in duration. Outcomes included change in bone mineral density (BMD), fractures, back pain and adverse events. Two independent reviewers abstracted data on study characteristics and outcomes. RESULTS: hPTH(1-34) significantly increases lumbar spine BMD, with smaller increases at the femoral neck and total hip. hPTH(1-84) significantly increases lumbar spine BMD. The data show a significant reduction in both vertebral and nonvertebral fractures with hPTH(1-34) in postmenopausal women with previous vertebral fractures. There were no data on fractures comparing the approved dose of hPTH(1-34) with active comparators. INTERPRETATION: There is Level I evidence that hPTH(1-34) significantly increases BMD at all skeletal sites except the radius and significantly reduces the risk of new vertebral and nonvertebral fractures in postmenopausal women with prior fractures.

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