Baseline DEXA Research Articles

12453 Osteoporosis Screening In A Primary Care Clinic: Barriers And Solutions

Abstract Disclosure: B.M. Laquidara: None. S. Mistry: None. L. Guo: None. Purpose/Objective: Osteoporosis is a prevalent bone disorder that affects over 10 million people in the United States. The US Preventive Services Task Force (USPSTF) recommends screening females aged 65 and older with a baseline DEXA scan and to screen postmenopausal females younger than age 65 who have an increased risk of osteoporosis. Despite these guidelines, the screening rate for osteoporosis remains very low. Our quality improvement project seeks to first identify at what rate eligible patients in our residency primary care clinic are being screened for osteoporosis and what barriers (patient, provider, or clinical factors) to screening may decrease this rate. Methods: We reviewed a random sample medical records of 300 female patients aged >/= 50 years who visited our clinic within the last two years. We collected patient demographics, insurance status, presence of ≥1 risk factor of osteoporosis (fracture, heavy alcohol use, tobacco use, steroid use, BMI<19), MyChart activity, provider training level, diagnosis code, and whether a baseline DEXA was ordered and/or completed. We compared patient characteristics by DEXA order status using descriptive statistics, and used multivariable regression models to determine odds of DEXA order and completion. Results: The patients who were at high risk for osteoporosis were more likely to have an order without completion (OR 6.11, p <0.001). Increased age was associated with increased odds of having an order (OR 1.09, p<0.001). Increasing BMI was associated with decreased odds of having an order. Black patients and current smokers were less likely to have a DEXA scan ordered and completed after controlling for age and other confounding factors (p= 0.002 and 0.001 respectively). Among the 96 patients who had a completed DEXA scan, 74 had osteoporosis. The only significant predictor for having osteoporosis was low BMI (OR 0.87%, p<0.001). Conclusion: The results of this study suggest that while patients with a clinically high risk for osteoporosis are more likely to have an order placed for a DEXA scan, these patients often do not have a completed scan. Patients who have an ICD-10 diagnosis of high-risk for osteoporosis or osteoporosis in their electronic medical record are more likely to have both an ordered and completed scan. Utilizing this data, we will develop a variety of interventions such as a clinical didactic case for osteoporosis, a flow-sheet summary of proper osteoporosis screening and treatment initiation to be distributed in the clinic setting, and a short presentation during noon didactics where we review the proper screening method for osteoporosis. Following our intervention, we will re-examine the screening rate in our residency clinic to evaluate the effect of our intervention. Presentation: 6/3/2024

Aromatase inhibitors and fracture prevention – do 2017 guidelines work in real world?

ObjectivesAromatase inhibitor induced bone loss (AIBL) is a recognised adverse event with resultant increase in fracture risk. We aimed to determine the real-world impact of the 2017 consensus guidelines on AIBL and see if it is effective in fracture prevention.MethodsOver a 7-year study period, 1001 women prescribed AI were split in two groups. First group were offered bone active treatment based on NOS 2008 guidelines whereas the second group followed the 2017 consensus guidelines.Results1001 women were included.First group: 361 women had a baseline DEXA with 143 (40%) women who had a normal DEXA, 174 (48%) had osteopenia and 44 (12%) had osteoporosis. Of the women with osteopenia, 44 (25%) women were offered treatment, and 22 (13%) women had a fracture. Second group: 640 women had a baseline DEXA with 216 (33%) women with a normal result, 322(50%) had osteopenia and 107 (17%) had osteoporosis. Of the women with osteopenia, 127 (39%) women were offered treatment, and 8 (2.5%) women had a fracture.ConclusionsOur study provides real world evidence of the success of 2017 consensus statement in lowering fracture risk. A significant reduction in fractures pre (13%) and post guidelines change (2.5%) was demonstrated (absolute risk reduction of 10.5%) which has implications for healthcare systems worldwide as we have demonstrated this approach can reduce morbidity.Lay summaryBreast cancer is the most common cancer in women with over two million women diagnosed with it annually. Early diagnosis and treatment with hormonal therapies have helped reduce mortality. Aromatase inhibitors (AIs) are the main drugs in this class and have demonstrated improved survival. However, whilst conveying major benefits, AIs reduce oestrogen levels leading to significant bone loss and increasing fracture risk. Several protocols have been recommended to address this concern. We compared the two guidelines published by National Osteoporosis Society UK in 2008 and consensus statement recommended by seven breast cancer and bone health groups in 2017 to see which work better in preventing fractures in women prescribed AIs for breast cancer. Our study shows that the 2017 guidelines are better at preventing fractures in the real world. Hence, we suggest that these should be adopted by specialists treating breast cancer which can help women avoid fractures and improve long term health.

Quality improvement project in primary care to improve management of women with premature ovarian insufficiency

Background: Premature Ovarian Insufficiency (POI) is defined as the loss of ovarian activity before the age of 40 years. The prevalence in the general population is an estimated 1% in the UK. If untreated, POI can cause serious long term health consequences, including increased risk of cardiovascular disease, osteoporosis, impaired cognition, reduced psychological wellbeing, and quality of life. To lower the risk of these, hormone replacement therapy (HRT) is advised until the natural age of the menopause. Investigations are recommended by ESHRE to look at primary causes as well as a baseline DEXA scan. We present results from a study exploring prevalence, diagnosis, and management of POI in an urban Primary Care Practice in East London.

Barriers to guideline-concordant use of bone modifying agents for prostate cancer.

68 Background: NCCN Guidelines recommend the use of bone-modifying agents (BMAs) to prevent skeletal-related events (SRE) for patients with castrate-resistant prostate cancer (CRPC) and bone metastasis, but not for castrate-sensitive prostate cancer (CSPC). Prior studies have identified both underuse of BMAs for CRPC and overuse for CSPC, but the clinical circumstances underlying these apparent gaps in care are unknown. Methods: Qualitative interview study, with physicians who treat prostate cancer within an academic cancer center and an affiliated network of community-based practices. Using a semi-structured interview guide, an experienced moderator probed participants’ experiences and perceptions around NCCN Guidelines recommendations, guideline adherence and non-adherence, and barriers to adherence. Interviews also probed participants’ views of potential interventions to promote guideline-concordant BMA use. Participants used Likert-scale items to rate the likely effectiveness of each intervention in influencing BMA practice patterns. They also identified the 3 most helpful interventions for reducing BMA underuse and overuse separately. Results: 19 physicians were invited, of whom 15 agreed to participate; 1 physician did not respond to some questions as outside scope of practice. All were aware of the recommendation for use of BMAs in CRPC. 14% (2/14) were unaware of the recommendation against BMA use for CSPC; an additional 29% (4/14) believed that BMA use could be appropriate for CSPC depending on the burden of bony metastatic disease. 36% (5/14) were unaware of recommendations for baseline DEXA scan and BMA for patients with low bone mineral density. The most commonly reported barriers (occurring “often” or “sometimes”) to BMA use for CRPC were obtaining dental clearance (11/15) and insufficient time in clinic (6/15). The interventions perceived as most helpful to reduce underuse for CRPC were dental navigation (11/15) and EMR-based guidance (9/15). The interventions identified as most helpful to reduce overuse for CSPC were peer-to-peer education (14/15) and EMR-based guidance (13/15). Conclusions: Among physicians treating prostate cancer in our study, there was incomplete awareness of guideline recommendations for screening and treatment of low bone mineral density, and against BMA use for SRE prevention in CSPC. Dental navigation, peer-to-peer education, and EMR-based guidance were preferred implementation strategies to reduce underuse and overuse of BMAs.

Abstract GS4-01: Ten-year results from NRG Oncology/NSABP B-42: A randomized, double-blinded, placebo-controlled clinical trial of extended adjuvant endocrine therapy with letrozole (L) in postmenopausal women with hormone-receptor+ breast cancer (BC) who have completed previous adjuvant therapy with an aromatase inhibitor (AI)

Abstract Background: In the NSABP B-42 trial we aimed to determine whether 5 yrs of letrozole (L) v placebo (P) improves DFS in patients (pts) who have completed 5 yrs of hormonal therapy (tx). 3966 postmenopausal pts with stage I-III, hormone-receptor+ BC, disease-free after 5 yrs of an AI or tamoxifen (TAM) for ≤3 years → AI for the remainder of 5 yrs, were randomized to L 2.5 mg or P daily for an additional 5 yrs. In the primary analyses the beneficial effect of extended tx with 5 yrs of L did not reach statistical significance on disease-free survival (DFS). There was no significant improvement in overall survival (OS) with L, but L did provide a significant improvement in breast-cancer-free interval (BCFI) and distant recurrence (DR). The updated results based on the data received as of April 30, 2019, are presented here. Methods: Stratification was by pathological nodal status, prior adjuvant TAM or not, and baseline dexa T scores (>-2.0, ≤-2.0 SD). Primary endpoint was DFS including local, regional, distant recurrence, second primary cancers, and deaths from any cause as first event. Secondary endpoints included OS, BCFI (including recurrence or contralateral BC as first event), DR, osteoporotic fractures (OF), and arterial thrombotic (AT) events. Differences in DFS, OS, BCFI, DR, OF, and AT between L and P were assessed by the stratified log-rank tests and Cox proportional hazards models. Statistical significance level was set at 0.05. Results: Median follow-up for 3923 pts included in the current analyses was 9.3 yrs. As of 4/30/19, 890 DFS events had occurred (L=411, P=479); L resulted in a statistically significant increase in DFS v P (HR=0.84; 95% CI 0.74, 0.96; p=0.011); 10-yr DFS was L=76.1% and P=72.1%. The effect of L was statistically significantly different for pts with baseline T score ≤-2.0 (HR=0.63; 95% CI 0.49, 0.82) v those with a score >-2.0 (HR=0.93; 95% CI 0.80, 1.09) (interaction p=0.013). 495 deaths occurred (L=243, P=252); there was no statistically significant difference in OS with L v P (HR=0.97, 95% CI 0.82, 1.16; p=0.77); 10-yr OS was L=86.1% and P=85.5%. 413 BCFI events occurred (L=178, P=235); L v P resulted in a statistically significant 26% decrease in BCFI events (HR=0.74, 95% CI 0.61, 0.91; p=0.003); 10-yr cumulative incidence (Cum In) of BCFI was L=10.3% v P=13.3%. 229 DRs occurred (L=96, P=133); L v P resulted in a statistically significant 29% reduction in DR (HR=0.71, 95% CI 0.55, 0.93; p=0.01); 10-yr Cum In of DR was L=5.7% v P=7.5%. There were 209 OF (L=109, P=100). There were no significant differences in time to OF with L v P (P=0.46). Cum In of OF through 10 yrs was L=6.5% v P=6.4%. There were 154 AT events (L=82, P=72). Treatment with L did not result in an overall statistically significant increase in AT events compared to P (p=0.38). Cum In of AT through 10 yrs was L=4.7% v P=4.1%. Conclusions: The effect of extended tx with 5 yrs of L on DFS persisted in the updated analyses and reached statistical significance. There was no significant improvement in OS with L, but L continued to provide a significant improvement in BCFI and DR. Support: U10CA180868, -180822; UG1CA189867; Korea Health Technology R&D Project; Novartis. Citation Format: Eleftherios P Mamounas, Hanna Bandos, Barry C Lembersky, Jeon Hyeon Jeong, Charles E Geyer, Jr, Priya Rastogi, Louis Fehrenbacher, Mark L Graham, Stephen K Chia, Adam M Brufsky, Janice M Walshe, Gamini S Soori, Shaker R Dakhil, Thomas E Seay, James L Wade, III, Edward C McCarron, Soonmyung Paik, Sandra M Swain, D Lawerence Wickerham, Norman Wolmark. Ten-year results from NRG Oncology/NSABP B-42: A randomized, double-blinded, placebo-controlled clinical trial of extended adjuvant endocrine therapy with letrozole (L) in postmenopausal women with hormone-receptor+ breast cancer (BC) who have completed previous adjuvant therapy with an aromatase inhibitor (AI) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr GS4-01.

Abstract S1-05: A randomized, double-blinded, placebo-controlled clinical trial of extended adjuvant endocrine therapy (tx) with letrozole (L) in postmenopausal women with hormone-receptor (+) breast cancer (BC) who have completed previous adjuvant tx with an aromatase inhibitor (AI): Results from NRG Oncology/NSABP B-42

Abstract Background: Extending adjuvant endocrine therapy (tx) after 5 yrs of tamoxifen (Tam) with either Tam or an AI improves disease-free survival (DFS) in early-stage breast cancer (BC). However, optimal duration of adjuvant AI tx beyond 5 yrs is unknown. NSABP B-42 aimed to determine whether 5 yrs of letrozole (L) v placebo (P) improves DFS in patients (pts) who have completed 5 yrs of hormonal tx (with either AI or TAM→AI). Methods: Postmenopausal pts with stage I-III, hormone-receptor (+) BC, disease-free after 5 yrs of either AI or Tam for ≤3 years→AI for the remainder of 5 yrs, were randomized to L 2.5 mg or P daily for an additional 5 yrs. Stratification was by pathological nodal status, prior adjuvant Tam or not, and baseline dexa T scores (>-2.0, ≤-2.0 SD). Primary endpoint was DFS including local, regional, distant recurrence (DR), second primary cancers, and deaths from any cause as first event. Secondary endpoints included overall survival (OS), BC-free interval (BCFI including recurrence or contralateral BC as first event), DR, osteoporotic fractures (OF), and arterial thrombotic (AT) events. Differences in DFS, OS, BCFI, DR, OF, and AT between L and P were assessed by the stratified log-rank tests and Cox proportional hazards models. Statistical significance level for DFS was set at 0.0418 as per statistical plan. Results: From 9/06-1/10, 3966 pts were randomized (34% were <60 yrs, 57% were node-negative, 39% received prior TAM, 14% were HER-2 neu positive). Median follow-up for 3923 pts included in efficacy analyses was 6.9 years. As of 8/16, 631 DFS events occurred (L=292, P=339); L did not result in statistically significant increase in DFS v P (HR=0.85; 95% CI 0.73, 0.999; P=0.048), even after adjusting for age or surgery type; 7-yr DFS was L=84.7% and P=81.3%. There were no significant interactions between treatment and stratification variables. 310 deaths occurred (L=164, P=146); there was no statistically significant difference in OS with L v P (HR=1.15, 95% CI 0.92, 1.44; P=0.22); 7-yr OS was L=91.8% and P=92.3%; 306 BCFI events occurred (L=127, P=179); L v P resulted in a statistically significant 29% decrease in BCFI events (HR=0.71, 95% CI 0.56, 0.89; P=0.003); 7-yr cumulative incidence (CIn) of BCFI was L=6.7% v P=10%; 175 DRs occurred (L=73, P=102); L v P resulted in a statistically significant 28% reduction in DR (HR=0.72, 95% CI 0.53, 0.97; P=0.03). There were 169 OF (L=91, P=78). There were no significant differences in time to OF with L v P (P=0.27). CIn of OF through 7 yrs was L=5.4% v P=4.8%. There were 127 AT events (L=69, P=58). Treatment with L did not result in an overall statistically significant increase in AT events compared to P (P=0.33). CIn of AT through 7 yrs was L=3.9% v P=3.3%. Conclusions: After 5 yrs of an AI or TAM→AI, the beneficial effect of extended tx with 5 yrs of L on DFS did not reach statistical significance. There was no significant improvement in OS with L but L provided a significant improvement in BCFI and DR. Support: U10CA180868, -180822; UG1CA189867; Novartis. Citation Format: Mamounas EP, Bandos H, Lembersky BC, Geyer, Jr CE, Fehrenbacher L, Graham ML, Chia SL, Brufsky AM, Hennessy BT, Soori GS, Dakil SR, Seay TE, Wade, III JL, McCarron EC, Paik S, Swain SM, Wickerham DL, Wolmark N. A randomized, double-blinded, placebo-controlled clinical trial of extended adjuvant endocrine therapy (tx) with letrozole (L) in postmenopausal women with hormone-receptor (+) breast cancer (BC) who have completed previous adjuvant tx with an aromatase inhibitor (AI): Results from NRG Oncology/NSABP B-42 [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr S1-05.

P134. Does immediate breast reconstruction delay adjuvant therapy?

on AIs should have baseline dexa scan within 3 months of commencement. Calcium tablets or bisphosphonates should be given if osteopaenia or osteoporosis is identified. We aimed to compare our current practice with NICE guidelines (CG80). Methods: Patients were prospectively identified from breast follow up clinics during a 4 month period (August 2014eNovember 2014). Demographics, adjuvant therapy and bone health management plans were recorded and analysed. Results: 22 patients were identified. Median age was 66, range [55e92]. 18% were on neoadjuvant hormonal therapy. The majority of patients (86%) were on letrozole whereas 7% of patients were on exemestane and 7% on anastrozole. A clear bone health management plan was achieved in 30% of patients. 45.5% (10/22) of patients had a baseline DEXA scan, 40% (4/10) of those within timeframe. 70% (7/10) of patients had normal baseline DEXA scan and all have received lifestyle advice. Osteoporosis and osteopaenia was reported in 20% (2/10) and 10% (1/ 10) of patients respectively. All patients with osteoporosis were on bisphosphonates. In patients with osteopaenia there was no evidence of information for receiving additional calcium medications. Conclusions: Baseline bone health is poorly characterised in this series. It is crucial to assess bone density and a clear system needs to be developed in order to optimise bone health.

Effects of an Exercise and Diet‐Induced Weight Loss Program on Resistin and Visfatin in Sedentary Obese Women

Resistin and visfatin are secreted by adipose tissue and potential regulators of inflammation and insulin sensitivity. This study examined the effects of exercise and diet‐induced weight loss on resistin, visfatin and other adiposity and inflammatory markers. 26 sedentary obese women were randomly assigned into a control (C) or an exercise (E) group that involved circuit resistance‐exercise (4 d/wk) with walking (10,000 steps/d, 3 d/wk) while consuming 1,200 kcal/day for 1‐wk and 1,500 kcal/d diet for 11 wks consisting of 45:30 % PRO:CHO. Baseline and post‐training DEXA body composition and fasting blood samples were obtained and analyzed by MANOVA and Pearson correlation analysis. Data are presented as mean±SD changes from baseline. Participants in the E group lost more weight (E: ‐13.0±8.9; C: ‐1.4±3.1 lbs, p=0.001) and fat (E: ‐5.1±4.5; C:‐0.4±1.5 kg, p=0.001). Significant differences were seen between groups in leptin (E: ‐19.8±21.9; C: 4.5±16 ng/ml, p=0.003) while visfatin (E: ‐0.09±15.4; C: 89.3±177 ng/ml, p=0.095), IL‐6 (E: ‐38.9±46; C:264.4±597 %, p=0.093), TNF‐α (E: 1.57±28; C: 96.9±186 %, p=0.093), and insulin (E: ‐8.5±14.9; C:0.12±7.7 uIU/ml, p=0.070) tended to differ between groups and no differences were seen in resistin (E: 5.7±126; C: ‐62.3±162 ng/ml, p=0.25) or glucose (E: ‐3.8±19.8; C:‐2.8±6.9 %, p=0.87). Significant correlations were seen between changes in resistin and TNF‐α (r = ‐0.49) while changes in visfatin correlated with changes in leptin (r=0.51) and IL6 (r=0.91). These findings indicate that exercise has beneficial effects on weight loss and body composition and this may adiposity and inflammatory markers.

Bone health in prostate cancer patients: A survivorship issue requiring intervention.

247 Background: In general, men are not routinely screened for bone health. Prostate cancer patients are at an increased risk because of treatment with androgen deprivation therapy (ADT). Unlike other patients diagnosed with a malignancy, they may survive a long time. Some risk factors include inadequate calcium, vitamin D deficiency, tobacco use and alcohol abuse. We implemented a pre-ADT program to mitigate the effects of ADT on bone health. This study evaluates the pre-existing risk factors and bone health by baseline DEXA scans pre-ADT initiation. Methods: We completed a chart review of 182 veterans referred to Radiation Oncology for curative treatment of prostate cancer from 2009 to 2013. Of those, 160 patients underwent baseline DEXA scans. Clinical variables analyzed were demographics, tobacco and alcohol use, vitamin D levels, incidence of AODM (adult onset diabetes mellitus), and calcium or vitamin D intervention. Descriptive statistics and bivariate analysis including Chi Square tests and odds ratios were carried out. Results: The mean age of the study participants was 66.6 years (range 47-82.8 years). Baseline DEXA scans were abnormal in 63% of patients, showing osteoporosis and/or osteopenia. Vitamin D levels were abnormal in 61% of patients- 26% of whom had normal DEXA scans. Twenty percent had a history of alcohol abuse, and 56% used tobacco; 33% had AODM. Smokers with an abnormal Vitamin D level were at increased risk of bone disease as compared to non smokers (OR 3.23, 95% CI 1.35-7.69 p<0.01). Variables significantly impacting bone health were age (OR 1.087, p=0.012, 95% CI 1.018-1.161) and Tobacco use (OR 0.424, p=0.045, 95% CI 0.183-0.980). Almost 90% of the patients in this study had intermediate risk prostate cancer with an expected cancer specific survival of 85 to 90% at 5 to 10 years. Conclusions: Pre-ADT screening confirms the risk of underlying bone disease in this veteran population with an expectation of long term survival. Guidelines for treatment and prevention of bone disease should be implemented in all patients over age of 50. Particular attention should be paid to patients who underwent ADT. This can affect the quality of life in this group of cancer survivors.

Bone health in prostate patients: An opportunity for screening and intervention.

9623 Background: Despite known risk factors, men are not routinely screened for bone health. Men with prostate cancer are at an increased risk of bone disease because of treatment with androgen deprivation therapy (ADT). Risk factors include family history, calcium and vitamin D deficiency, certain medications, being thin or small-boned, tobacco use, alcohol abuse. and lack of physical activity. We started a screening and management program to mitigate the effects of ADT on bone health in veterans beginning treatment for prostate cancer. This study evaluates the pre-existing risk factors in pts who had baseline dexa scans before ADT. Methods: We completed a retrospective chart review of 182 veterans diagnosed with prostate cancer and referred to Radiation Oncology for radical treatment from 2009 to 2013. This reports on the 160 pts who had baseline dexa scans. Clinical variables analyzed were demographics, tobacco and alcohol use, vitamin D levels, incidence of AODM (adult onset diabetes mellitus), and calcium or vitamin D use. Descriptive statistics as well as bivariate analysis including Chi Square tests and odds ratios were calculated. Results: The mean age of the study participants was 66.6 yrs (47-82.8 yrs); 52% were African American, 45% White, 3% Hispanic. Baseline dexa scans were abnormal in 63% of pts, showing osteoporosis and /or osteopenia. Vitamin D levels were abnormal in 61%. Abnormal vitamin D levels were found in 26% of pts with normal DEXA scans. Almost 99% pts received calcium and Vitamin D supplements. Twenty percent had a history of alcohol abuse, 56% used tobacco, and 33% had AODM. Ethnicity may be a factor ( p<0.05) but the sample sizes per group were not equivalent. Smokers with an abnormal Vitamin D level were at increased risk of bone disease as comparedto non smokers (p<0.01) . Conclusions: Pre-ADT screening confirms the risk of underlying bone disease in this previously unscreened veteran population. Guidelines for treatment and prevention of bone disease should be implemented in all patients over age of 50. An opportunity exists to identify and treat men at risk when seen for prostate cancer treatment whether they receive ADT or not.

Incidence of and Predictive Factors for Recovery of Ovarian Function on Letrozole in ER-Positive Breast Cancer Patients in Their Forties Who Cease Menstruating with Adjuvant Chemotherapy.

Abstract Background: We conducted an open-label pilot study of 2 years of aromatase inhibitor (AI) therapy in women in their 40's with ER-positive breast cancer who had ceased menstruating with adjuvant cyclophosphamide-based chemotherapy, had postmenopausal serum estradiol (E2) levels, and had been on tamoxifen (Tam) for at least 1 year. The primary objective was to determine if serial FSH levels while on letrozole predicted for ovarian recovery (resumption of menses or premenopausal E2/FSH levels) and secondary objectives included evaluation of serial E2, inhibin A and B levels and osteopenia on baseline DEXA scan as predictors of ovarian failure.Patients and Methods: Patients who had ceased menstruating and who had a postmenopausal estradiol level on tamoxifen at study entry were treated for up to 2 years with letrozole following at least 1 year of Tam; patients who were on another AI at study entry were permitted to continue on that therapy. All patients underwent evaluation of serum FSH and E2 levels every 3 months for 1 year and then every 6 months during Year 2; baseline and end of Year 1 inhibin A and B levels; and baseline assessment of bone mineral density (BMD). Patients consented to strict birth control measures and stopped letrozole therapy at evidence of ovarian function recovery.Results: 173 patients were enrolled on study and we report now on the findings in the 30 patients &amp;lt;45 years old (mean age 43). 96% of the patients were on letrozole. Median time from end of cyclophosphamide to start of letrozole was 23 months and median duration of Tam treatment prior to starting letrozole was 18 months. Seven patients (23%) resumed menses; 5 additional patients (17%) developed both premenopausal levels of FSH (&amp;lt;23 IU/L) and E2 (&amp;gt;31 pg/mL) without menses; and an additional 6 patients (20%) had isolated premenopausal E2 levels. The average time to recovery of ovarian function as above on letrozole was 14 months (range 2.4 - 29 months). Postmenopausal baseline inhibin A and B levels did not accurately predict for lack of ovarian recovery. Of the 18 patients with menses or biochemical evidence of ovarian recovery, 5 (28%) had osteopenia (T score &amp;lt;-1) at study entry while 4 of 12 patients (33%) without ovarian recovery had baseline osteopenia. In patients who had ovarian recovery on letrozole, FSH levels that were suppressed on Tam tended to rise over 6-10 months on letrozole and then return to premenopausal levels.Conclusion: Women &amp;lt;45 years of age who have persistent amenorrhea with adjuvant chemotherapy followed by Tam have a high incidence of ovarian recovery on letrozole. After initial rises in FSH levels following the switch from Tam to letrozole, subsequent declines in FSH levels predict for ovarian recovery.Supported, in part, by Novartis Pharmaceuticals, Corp., East Hanover, NJ. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 6097.

Muscle atrophy and long bone osteopenia are attenuated with n‐3 PUFA in a mouse model of hindlimb suspension

Muscle atrophy and osteopenia are common issues associated with aging and disease. This study was conducted to evaluate the effects of long chain n‐3 PUFA [eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids] on muscle and bone loss in a mouse model of induced hindlimb atrophy. Mouse hindlimb suspension (HS) is used as a disuse model to induce muscle atrophy and bone loss compared to weight bearing (WB). Six‐wk‐old male mice (ND4 Swiss Webster) were fed a control (n‐6 PUFA, n= 26), a moderate n‐3 PUFA (EPA + DHA 12 g/kg, n = 20), or a high n‐3 PUFA (19.4 g/kg, n= 21) diet for 2 wks. After pre‐feeding, mice were subjected to a baseline DEXA scan and then assigned to the WB or HS groups. Upon 14 days of HS or continued WB, mice were anesthetized for a repeated DEXA scan after which the mice were euthanized, and tissues were collected for analyses. Mice fed n‐3 PUFA demonstrated an elevation of EPA and DHA and reduced arachidonate in serum and tissues. HS resulted in fat, muscle mass and bone mineral content (BMC) losses. Bone ash was conserved in the HS n‐3 PUFA fed groups compared to control HS mice, which supports the protection of BMC/body wt also found in the n‐3 fed groups. There was no additional protection of bone in the high n‐3 diet group compared to the moderate group. Based on this study in mice and other investigations with rodents, the n‐3 PUFA appear to attenuate the physiological changes that occur with HS. Supported by USDA funds.

Screening and Treatment of Glucocorticoid-Induced Osteoporosis in Rheumatoid Arthritis Patients in an Urban Multispecialty Practice

Despite increased awareness of glucocorticoid-induced osteoporosis, physicians are not providing recommended screening and treatment. The number of patients receiving bone density measurements, primary prevention, and secondary treatment remains low. To analyze physician adherence of rheumatologists in an urban multispecialty group to the American College of Rheumatology 2001 ad hoc committee guidelines for the prevention and treatment of glucocorticoid-induced osteoporosis in patients with rheumatoid arthritis (RA). The practice evaluated is a multispecialty practice in an urban setting affiliated with a teaching hospital. A retrospective chart review was performed. The names of 428 patients with RA were obtained by billing query. One hundred thirty-six charts met criteria for final analysis. Charts were reviewed for long-term corticosteroid use >or=5 mg/d for >or=6 months, baseline bone density scans, use of calcium and vitamin D, use of hormone replacement therapy, use of calcitonin, and use of a bisphosphonate. 59.7% of patients qualified as long-term corticosteroid users. Only 37% of long-term corticosteroid users received baseline bone density scans. Bone loss was documented in 70.4% of corticosteroid users who received baseline DEXA scans. Only 38.9% of long-term corticosteroid users received the recommended treatment of bisphosphonates or HRT with calcium plus vitamin D according to ACR guidelines. Less then 40% of long-term corticosteroid users with RA received recommended DEXA scanning and treatment in a multispecialty rheumatology urban practice.

Screening and management of osteoporosis in breast cancer patients on aromatase inhibitors

Breast cancer patients are at an increased risk of osteoporosis due to age, cancer, chemotherapy, and aromatase inhibitor therapy. This retrospective review determined if patients treated with aromatase inhibitors received appropriate screening and management for osteoporosis. University of Colorado Cancer Center breast cancer patients treated with aromatase inhibitor therapy during July 2005 through July 2006 were studied. Data was collected for each patient from the time of breast cancer diagnosis up to April 2007. The study endpoints included (1) appropriate screening for osteoporosis, (2) incidence of osteoporosis diagnosis, and (3) initiation of appropriate drug therapy for bone loss. Appropriate management was defined as adherence to the 2003 American Society of Clinical Oncology guidelines for bone health issues in women with breast cancer. Of the 54 patients included in this study, 12 (22.2%) had no DEXA scans documented, 22 (40.7%) patients received a baseline DEXA scan and 8 (14.8%) patients received baseline and yearly DEXA scans. During the study timeline, 26 (48%) patients were diagnosed with osteopenia and 4 (7%) patients were diagnosed with osteoporosis. Forty-one (75.9%) patients received calcium and vitamin D therapy. Bisphosphonate therapy was received by less than one-third of the osteopenic patients and three-fourths of the osteoporotic patients. The majority of patients were not adequately screened which may have falsely lowered the diagnosis of osteoporosis resulting in omission of drug therapy. All high-risk patients should receive calcium and vitamin D therapy and be evaluated for bisphosphonate therapy. Screening and medical management for osteoporosis in breast cancer patients on aromatase inhibitors is an important area for clinical intervention.

A Prospective, Controlled Longitudinal Study of the Effects of Oral Corticosteroid Therapy on Bone Mineral Density in Patients with IBD

Purpose: There is very limited data regarding the duration and dose of steroids required to produce bone loss in IBD. The objective of this study is to prospectively determine the rate and degree of bone loss in IBD patients treated with prednisone (pred), compared to a group of IBD patients matched for disease activity not treated with prednisone (non-P). Methods: Pred patients (n = 17) underwent baseline DEXA to determine baseline bone mineral density (BMD) at the lumbar spine (LS), and bilateral hips, and were compared to non-P patients (n = 15) with active disease. DEXA scans were repeated at 3 months after initiating prednisone, or alternate therapy, for non-P patients. Prednisone was started at 40–60 mg/d and tapered according to a fixed schedule based upon clinical response. All patients were treated empirically with oral calcium 1500 mg/d and vitamin D 600 u/d. Results: For pred patients compared with non-P patients, there were no differences in the gender (M:F = 11:6 vs 11:4), age (36 vs. 44), There was a lower proportion of CD patients in the pred group (3/17) than in the non-P group (12/15, p=.001). All women were premenopausal. Patients in both groups had similar baseline disease activity. Pred patients had higher t scores for both LS and hips at baseline. Values for baseline t scores, and 3 month changes in t score and% BMD are shown in the Table below. p values are for differences between the pred and non-P groups.TableThere was also a higher proportion of pred patients with a clinically significant, i.e >5%, decline in BMD at the hips, than in the non-P group (5/17 vs. 0/14, p=.04). Conclusions: In this prospective, controlled study, a < 3 month course of prednisone, led to a significantly greater decline in BMD at the hips (but not at the spine) compared to control patients at 3 months. Significant bone loss at the hips, as defined by a greater than 5% decline in BMD, can be seen as early as 3 months in these patients with active IBD being treated with a tapering course of prednisone, despite concurrent supplemental calcium and vitamin D.