Aimee D. Shu

All Publications

• Patient-Reported Outcomes in Palopegteriparatide-Treated Adults with Hypoparathyroidism: PaTH Forward Trial Extension. The Journal of clinical endocrinology and metabolism Rubin, M., Palermo, A., Vokes, T., Khan, A. A., Schwarz, P., Cetani, F., Pagotto, U., Tsourdi, E., Sikjaer, T., Pfeiffer, K. M., Brod, M., McLeod, L. D., Zhao, C., Noori, W., Shu, A. D., Smith, A. R. 2025

  Abstract

  Individuals with hypoparathyroidism experience a range of physical and cognitive symptoms and reduced quality of life (QoL) despite management with conventional therapy (active vitamin D and calcium).This analysis investigated the long-term impact of parathyroid hormone (PTH) replacement therapy with palopegteriparatide (YORVIPATH®) on symptoms, daily functioning, and well-being in adults with chronic hypoparathyroidism. Associations between patient characteristics and changes in patient-reported outcomes (PROs) were also analyzed.PaTH Forward was a phase 2 clinical trial of palopegteriparatide with a 4-week randomized, double-blind, placebo-controlled period followed by an open-label extension period lasting through trial week 266. PRO measures were collected at baseline, weeks 4, 12, 26, 58, and annually thereafter through the end of the trial. The Hypoparathyroidism Patient Experience Scales (HPES) assess disease-specific symptoms and impacts on functioning and well-being. The Short-Form Health Survey (SF-36v2) measures general health-related QoL. Data were analyzed using descriptive statistics and Mixed Models for Repeated Measures (MMRM).Palopegteriparatide treatment demonstrated significant improvements from baseline in disease-specific symptoms and impacts on daily functioning and well-being at week 12, which were sustained through week 110. Mean changes in PROs met thresholds for clinically meaningful within-patient improvement. Significant improvements in general health-related QoL were also shown in SF-36v2 scores. Results were generally similar across demographics and patient characteristics.Through week 110 of the PaTH Forward trial, PTH replacement therapy with palopegteriparatide was associated with significant improvements in disease-specific symptoms and impacts on daily functioning and well-being, as well as general health-related QoL.

  View details for DOI 10.1210/clinem/dgaf653

  View details for PubMedID 41365829

• Once-Weekly Navepegritide in Children With Achondroplasia: The APPROACH Randomized Clinical Trial. JAMA pediatrics Savarirayan, R., McDonnell, C., Bacino, C. A., Hoernschemeyer, D. G., Legare, J. M., Abuzzahab, M. J., Hofman, P. L., Campeau, P. M., de Bergua Domingo, J. M., Ward, L. M., Smit, K., Smith, A., Mao, M., Ominsky, M. S., Freiberg, L. C., Shu, A. D., Hove, H. B. 2025

  Abstract

  Importance: Historically considered a skeletal dysplasia characterized by disproportionate short stature, achondroplasia is a condition with multisystemic effects due to the widespread expression of the fibroblast growth factor receptor 3 variant throughout the body, impacting muscle, neurological function, cardiorespiratory health, and health-related quality of life.Objective: To evaluate the efficacy, safety, and tolerability of once-weekly navepegritide, an investigational prodrug of C-type natriuretic peptide, while assessing benefits beyond growth that may have important implications for complications and health-related quality of life in children with achondroplasia.Design, Setting, and Participants: Enrollment for this pivotal phase 2b, randomized, double-blind, placebo-controlled trial (APPROACH) was conducted between March and August 2023 at 10 hospitals in Australia, Canada, Denmark, Ireland, New Zealand, Spain, and the US with randomized, blind treatment through 52 weeks and an open-label extension (ongoing). Eligible participants aged 2 to 11 years had achondroplasia confirmed by genetic testing, were naive to treatment with growth-promoting agents, and had their height recorded at least 6 months prior to randomization. Enrolled participants were stratified by age and sex. Those with radiographic evidence of closed growth plates, planned bone surgery, severe untreated sleep apnea, or medical conditions known to affect growth were excluded (n=2 of 86); of 84 participants enrolled, all were analyzed for safety and efficacy outcomes, including 2 who discontinued treatment.Interventions: Navepegritide (100 mug/kg/wk) or placebo administered by once-weekly subcutaneous injection.Main Outcomes and Measures: The primary end point was annualized growth velocity at week 52. Other clinically important secondary measures included radiographically assessed skeletal outcomes and health-related quality of life, evaluated using Achondroplasia Child Experience Measures. Safety assessments included adverse events, clinical laboratory assessments, bone age, and immunogenicity.Results: Eighty-four participants were enrolled and assigned randomly in a 2:1 ratio to receive navepegritide (n=57; mean [SD] age, 5.6 [2.6] years; 31 [54%] male) or placebo (n=27; mean [SD] age, 6.0 [2.7] years; 14 [52%] male). All randomized participants were included in efficacy and safety analyses, although 2 patients in the navepegritide group discontinued treatment (one at week 26 and the other at week 34). The trial met its primary end point, demonstrating superiority of navepegritide in annualized growth velocity at week 52 vs placebo (least-squares mean treatment difference of 1.49 cm/y; 95% CI, 1.05 to 1.93; P<.001). Treatment resulted in improvements (least-squares mean treatment difference [95% CI]) in tibial-femoral angle (-1.81° [-3.16 to -0.47]), mechanical axis deviation (-2.78 mm [-4.71 to -0.86]), fibula to tibia length ratio (-0.016 [-0.024 to -0.008]), and Achondroplasia Child Experience Measures-Physical Functioning (-11.1 [-21.5 to -0.80] in children younger than 5 years). No serious adverse events were treatment-related, and no deaths occurred. Injection site reaction rates were low, and no symptomatic hypotension or fractures were observed.Conclusions: In this randomized clinical trial, navepegritide treatment resulted in statistically significantly higher annualized growth velocity in children with achondroplasia, with a similar safety and tolerability profile vs placebo. Moreover, navepegritide demonstrated additional potential health benefits beyond growth.Trial Registration: ClinicalTrials.gov Identifier: NCT05598320.

  View details for DOI 10.1001/jamapediatrics.2025.4771

  View details for PubMedID 41247754

• Efficacy and Safety of Palopegteriparatide Treatment in Adults With Hypoparathyroidism: 3-Year Results From the Phase 3 PaTHway Trial Khan, A., Clarke, B., Rubin, M., Schwarz, P., Shoback, D., Gagnon, C., Palermo, A., Abbott, L., Kohlmeier, L., Tsourdi, E., Cetani, F., Jain, R., Zhao, C., Lai, B., Makara, M. A., Ukena, J., Sibley, C. T., Shu, A. D., Rejnmark, L., Bertocchio, J. SMW supporting association. 2025

  View details for Web of Science ID 001639841800027

• Long-Term Efficacy and Safety of Palopegteriparatide Treatment in Adults With Chronic Hypoparathyroidism: 4-Year Results From the Phase 2 PaTH Forward Trial Palermo, A., Khan, A., Rubin, M., Schwarz, P., Clarke, B., Pagotto, U., Tsourdi, E., Cetani, F., Jain, R., Zhao, C., Ominsky, M., Lai, B., Ukena, J., Sibley, C. T., Shu, A. D., Rejnmark, L., Bertocchio, J. SMW supporting association. 2025

  View details for Web of Science ID 001639841800051

• TRANSCON CNP (NAVEPEGRITIDE) IMPROVED PHYSICAL FUNCTIONING IN CHILDREN WITH ACHONDROPLASIA (ACH) IN THE APPROACH TRIAL Bacino, C., Savarirayan, R., Hove, H., Hoernschemeyer, D., Legare, J., Abuzzahab, M., Hofman, P., Campeau, P., Domingo, J., Smith, A., Jorgensen, A., Freiberg, L., Ominsky, M., Shu, A., McDonnell, C. KARGER. 2025

  View details for Web of Science ID 001649311400094

• Palopegteriparatide Improves Skeletal Dynamics in Adults With Chronic Hypoparathyroidism: 3-Year Results From the Phase 2 PaTH Forward Trial Rubin, M. R., Khan, A., Schwarz, P., Ahmed, I., Palermo, A., Tsourdi, E., Cetani, F., Pagotto, U., Jain, R., Zhao, C., Ominsky, M. S., Lai, B., Ukena, J., Shu, A., Rejnmark, L. OXFORD UNIV PRESS. 2024: 369

  View details for Web of Science ID 001361790802230

• Efficacy and Safety of TransCon PTH in Adults with Hypoparathyroidism: 52-Week Results From the Phase 3 PaTHway Trial. The Journal of clinical endocrinology and metabolism Clarke, B. L., Khan, A. A., Rubin, M. R., Schwarz, P., Vokes, T., Shoback, D. M., Gagnon, C., Palermo, A., Abbott, L. G., Hofbauer, L. C., Kohlmeier, L., Cetani, F., Pihl, S., An, X., Smith, A. R., Lai, B., Ukena, J., Sibley, C. T., Shu, A. D., Rejnmark, L. 2024

  Abstract

  Conventional therapy for hypoparathyroidism aims to alleviate symptoms of hypocalcemia but does not address insufficient parathyroid hormone (PTH) levels.Assess the long-term efficacy and safety of TransCon PTH (palopegteriparatide) for hypoparathyroidism.Phase 3 trial with a 26-week double-blind, placebo-controlled period followed by a 156-week open-label extension (OLE).21 sites across North America and Europe.82 adults with hypoparathyroidism were randomized and received study drug and 78 completed week 52.All OLE participants received TransCon PTH administered once daily.Multi-component efficacy endpoint: proportion of participants at week 52 who achieved normal serum calcium (8.3-10.6 mg/dL) and independence from conventional therapy (≤600 mg/day of elemental calcium and no active vitamin D). Other efficacy endpoints included patient-reported outcomes (PROs) and bone mineral density (BMD). Safety was assessed by 24-hour urine calcium and treatment-emergent adverse events (TEAEs).At week 52, 81% (63/78) met the multi-component efficacy endpoint, 95% (74/78) achieved independence from conventional therapy, and none required active vitamin D. PROs showed sustained improvements in quality of life, physical functioning, and well-being. Mean BMD Z-scores decreased toward age- and sex-matched norms from baseline to week 52. Mean (SD) 24-hour urine calcium excretion decreased from 376 (168) mg/day at baseline to 195 (114) mg/day at week 52. Most TEAEs were mild or moderate and none led to trial discontinuation during the OLE.At week 52 of the PaTHway trial, TransCon PTH showed sustained efficacy, safety, and tolerability in adults with hypoparathyroidism.

  View details for DOI 10.1210/clinem/dgae693

  View details for PubMedID 39376010

• Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial. Advances in therapy Rejnmark, L., Gosmanova, E. O., Khan, A. A., Makita, N., Imanishi, Y., Takeuchi, Y., Sprague, S., Shoback, D. M., Kohlmeier, L., Rubin, M. R., Palermo, A., Schwarz, P., Gagnon, C., Tsourdi, E., Zhao, C., Makara, M. A., Ominsky, M. S., Lai, B., Ukena, J., Sibley, C. T., Shu, A. D. 2024

  Abstract

  Individuals with chronic hypoparathyroidism managed with conventional therapy (active vitamin D and calcium) have an increased risk for renal dysfunction versus age- and sex-matched controls. Treatments that replace the physiologic effects of parathyroid hormone (PTH) while reducing the need for conventional therapy may help prevent a decline in renal function in this population. This post hoc analysis examined the impact of palopegteriparatide treatment on renal function in adults with chronic hypoparathyroidism.PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period. Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR). A subgroup analysis was performed with participants stratified by baseline eGFR < 60 or ≥ 60 mL/min/1.73 m2.At week 52, over 95% (78/82) of participants remained enrolled in the OLE and of those, 86% maintained normocalcemia and 95% achieved independence from conventional therapy (no active vitamin D and ≤ 600 mg/day of calcium), with none requiring active vitamin D. Treatment with palopegteriparatide over 52 weeks resulted in a mean (SD) increase in eGFR of 9.3 (11.7) mL/min/1.73 m2 from baseline (P < 0.0001) and 43% of participants had an increase ≥ 10 mL/min/1.73 m2. In participants with baseline eGFR < 60 mL/min/1.73 m2, 52 weeks of treatment with palopegteriparatide resulted in a mean (SD) increase of 11.5 (11.3) mL/min/1.73 m2 (P < 0.001). One case of nephrolithiasis was reported for a participant in the placebo group during blinded treatment; none were reported through week 52 with palopegteriparatide.In this post hoc analysis of the PaTHway trial, palopegteriparatide treatment was associated with significantly improved eGFR at week 52 in addition to previously reported maintenance and normalization of serum and urine biochemistries. Further investigation of palopegteriparatide for the preservation of renal function in hypoparathyroidism is warranted.ClinicalTrials.gov NCT04701203.

  View details for DOI 10.1007/s12325-024-02843-8

  View details for PubMedID 38691316

  View details for PubMedCentralID 8087595

• Once-weekly TransCon CNP (navepegritide) in children with achondroplasia (ACcomplisH): a phase 2, multicentre, randomised, double-blind, placebo-controlled, dose-escalation trial. EClinicalMedicine Savarirayan, R., Hoernschemeyer, D. G., Ljungberg, M., Zarate, Y. A., Bacino, C. A., Bober, M. B., Legare, J. M., Hogler, W., Quattrin, T., Abuzzahab, M. J., Hofman, P. L., White, K. K., Ma, N. S., Schnabel, D., Sousa, S. B., Mao, M., Smith, A., Chakraborty, M., Giwa, A., Winding, B., Volck, B., Shu, A. D., McDonnell, C. 2023; 65: 102258

  Abstract

  Background: TransCon CNP (navepegritide) is an investigational prodrug of C-type natriuretic peptide (CNP) designed to allow for continuous CNP exposure with once-weekly dosing. This 52-week phase 2 (ACcomplisH) trial assessed the safety and efficacy of TransCon CNP in children with achondroplasia.Methods: ACcomplisH is a global, randomised, double-blind, placebo-controlled, dose-escalation trial. Study participants were recruited between June 10, 2020, and September 24, 2021. Eligible participants were prepubertal, aged 2-10 years, with genetically confirmed achondroplasia, and randomised 3:1 to once-weekly subcutaneous injections of TransCon CNP (6, 20, 50, or 100mug CNP/kg/week) or placebo for 52 weeks. Primary objectives were safety and annualised growth velocity (AGV). ACcomplisH is registered with ClinicalTrials.gov (NCT04085523) and Eudra (CT 2019-002754-22).Findings: Forty-two participants received TransCon CNP at doses of 6mug (n=10; 7 female), 20mug (n=11; 3 female), 50mug (n=10; 3 female), or 100mug (n=11; 6 female) CNP/kg/week, with 15 receiving placebo (5 female). Treatment-emergent adverse events (TEAEs) were mild or moderate with no grade 3/4 events reported. There were 2 serious TEAEs that were assessed as not related to TransCon CNP. Eleven injection site reactions occurred in 8 participants receiving TransCon CNP and no symptomatic hypotension occurred. TransCon CNP demonstrated a dose-dependent improvement in AGV. At 52 weeks, TransCon CNP 100mug CNP/kg/week significantly improved AGV vs placebo (least squares mean [95% CI] 5.42 [4.74-6.11] vs 4.35 [3.75-4.94] cm/year; p=0.0218), and improved achondroplasia-specific height SDS from baseline (least squares mean [95% CI] 0.22 [0.02-0·41] vs-0·08 [-0.25 to 0.10]; p=0.0283). All participants completed the randomised period and continued in the ongoing open-label extension period receiving TransCon CNP 100mug CNP/kg/week.Interpretation: This phase 2 trial suggests that TransCon CNP is effective, safe, with low injection site reaction frequency, and may provide a novel, once-weekly treatment option for children with achondroplasia. These results support TransCon CNP at 100mug CNP/kg/week in the ongoing pivotal trial.Funding: Ascendis Pharma, A/S.

  View details for DOI 10.1016/j.eclinm.2023.102258

  View details for PubMedID 37823031

• Improved Skeletal Dynamics in Adults Treated With Palopegteriparatide for Hypoparathyroidism: 52-Week Analysis of Phase 3 PaTHway Trial Khan, A. A., Rubin, M. R., Shoback, D. M., Schwarz, P., Kohlmeier, L., Palermo, A., Clarke, B. L., Eriksen, E., Tsourdi, E., Cetani, F., Jain, R., Zhao, C., Lai, B., Ukena, J., Sibley, C. T., Ominsky, M., Shu, A. D., Rejnmark, L. OXFORD UNIV PRESS. 2023: 432-433

  View details for Web of Science ID 001266167002165

• TransCon PTH for Hypoparathyroidism: Skeletal Dynamics Through Week 58 of the Phase 2 PaTH Forward Trial Rubin, M., Clarke, B., Hofbauer, L. C., Khan, A., Schwarz, P., Vokes, T., Ahmed, I., Palermo, A., Marcocci, C., Pagotto, U., Eriksen, E., An, X., Lai, B., Le, J., Ukena, J., Shu, A. D., Rejnmark, L. WILEY. 2023: 27

  View details for Web of Science ID 001008985200080

• Efficacy and Safety of Parathyroid Hormone Replacement with TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research Khan, A. A., Rubin, M. R., Schwarz, P., Vokes, T., Shoback, D. M., Gagnon, C., Palermo, A., Marcocci, C., Clarke, B. L., Abbott, L. G., Hofbauer, L. C., Kohlmeier, L., Pihl, S., An, X., Eng, W. F., Smith, A. R., Ukena, J., Sibley, C. T., Shu, A. D., Rejnmark, L. 2022

  Abstract

  Conventional therapy for hypoparathyroidism consisting of active vitamin D and calcium aims to alleviate hypocalcemia but fails to restore normal parathyroid hormone (PTH) physiology. PTH replacement therapy is the ideal physiologic treatment for hypoparathyroidism. The double-blind, placebo-controlled, 26-week, phase 3 PaTHway trial assessed the efficacy and safety of PTH replacement therapy for hypoparathyroidism individuals with the investigational drug TransCon PTH (palopegteriparatide). Participants (n=84) were randomized 3:1 to once-daily TransCon PTH (initially 18 mug/d) or placebo, both co-administered with conventional therapy. The study drug and conventional therapy were titrated according to a dosing algorithm guided by serum calcium. The composite primary efficacy endpoint was the proportion of participants at week 26 who achieved: normal albumin-adjusted serum calcium levels (8.3-10.6 mg/dL), independence from conventional therapy (requiring no active vitamin D and ≤600 mg/day of calcium), and no increase in study drug over 4weeks prior to week 26. Other outcomes of interest included health-related quality of life measured by the 36-Item Short Form Survey (SF-36), hypoparathyroidism-related symptoms, functioning, and well-being measured by the Hypoparathyroidism Patient Experience Scale (HPES), and urinary calcium excretion. At week 26, 79% (48/61) participants treated with TransCon PTH versus 5% (1/21) placebo met the composite primary efficacy endpoint (p<0.0001). TransCon PTH treatment demonstrated a significant improvement in all key secondary endpoint HPES domain scores (all p<0.01) and the SF-36 Physical Functioning subscale score (p=0.0347) compared to placebo. Additionally, 93% (57/61) of participants treated with TransCon PTH achieved independence from conventional therapy. TransCon PTH treatment normalized mean 24-hour urine calcium. Overall, 82% (50/61) treated with TransCon PTH and 100% (21/21) placebo experienced adverse events; most were mild (46%) or moderate (46%). No study drug-related withdrawals occurred. In conclusion, TransCon PTH maintained normocalcemia while permitting independence from conventional therapy and was well-tolerated in individuals with hypoparathyroidism. This article is protected by copyright. All rights reserved.

  View details for DOI 10.1002/jbmr.4726

  View details for PubMedID 36271471

• Sustained Benefit of TransCon PTH, a Potential Hormone Replacement Therapy for Patients with Hypoparathyroidism, at Week 58 in the PaTH Forward Trial Khan, A., Schwarz, P., Rubin, M. R., Vokes, T., Clarke, B. L., Ahmed, I., Hofbauer, L. C., Palermo, A., Marcocci, C., Pagotto, U., Eriksen, E., Markova, D., Pihl, S., Le, J., Beckert, M., Shu, A. D., Rejnmark, L. WILEY. 2022: 350

  View details for Web of Science ID 000778074501484

• PaTH Forward: A randomized, double-blind, placebo-controlled phase 2 trial of TransCon PTH in adult hypoparathyroidism. The Journal of clinical endocrinology and metabolism Khan, A. A., Rejnmark, L., Rubin, M., Schwarz, P., Vokes, T., Clarke, B., Ahmed, I., Hofbauer, L., Marcocci, C., Pagotto, U., Palermo, A., Eriksen, E., Brod, M., Markova, D., Smith, A., Pihl, S., Mourya, S., Karpf, D. B., Shu, A. D. 2021

  Abstract

  CONTEXT: Hypoparathyroidism is characterized by insufficient levels of parathyroid hormone (PTH). TransCon PTH is an investigational long-acting prodrug of PTH(1-34) for the treatment of hypoparathyroidism.OBJECTIVE: Investigate the safety, tolerability, and efficacy of daily TransCon PTH in adults with hypoparathyroidism.DESIGN: Phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension.PATIENTS: Enrolled 59 subjects with hypoparathyroidism.INTERVENTIONS: TransCon PTH 15, 18, or 21 g PTH(1-34)/day or placebo for 4 weeks, followed by a 26-week extension where TransCon PTH dose was titrated (6-60 g PTH[1-34]/day).RESULTS: By Week 26, 91% of subjects treated with TransCon PTH achieved independence from standard of care (SoC, defined as active vitamin D = 0 mcg/day and calcium (Ca) ≤ 500mg/day). Mean 24-hour urine Ca (uCa) decreased from a baseline mean of 415mg/24h to 178mg/24h by Week 26 (n=44) while normal serum Ca (sCa) was maintained and serum phosphate (sP) and Ca x P fell within the normal range. By Week 26, mean scores on SF-36 domains increased from below normal at baseline to within the normal range. The Hypoparathyroidism Patient Experience Scale Symptom and Impact scores improved through 26 weeks. TransCon PTH was well-tolerated with no treatment-related serious or severe adverse events.CONCLUSIONS: TransCon PTH enabled independence from oral active vitamin D and reduced Ca supplements (≤ 500mg/day) for most subjects, achieving normal sCa, sP, uCa, CaxP, and demonstrating improved health-related quality of life. These results support TransCon PTH as a potential hormone replacement therapy for adults with hypoparathyroidism.

  View details for DOI 10.1210/clinem/dgab577

  View details for PubMedID 34347093

• Declining Rates of Inpatient Parathyroidectomy for Primary Hyperparathyroidism in the US. PloS one Kim, S. M., Shu, A. D., Long, J., Montez-Rath, M. E., Leonard, M. B., Norton, J. A., Chertow, G. M. 2016; 11 (8)

  Abstract

  Parathyroidectomy is the only curative therapy for patients with primary hyperparathyroidism. However, the incidence, correlates and consequences of parathyroidectomy for primary hyperparathyroidism across the entire US population are unknown. We evaluated temporal trends in rates of inpatient parathyroidectomy for primary hyperparathyroidism, and associated in-hospital mortality, length of stay, and costs. We used the Healthcare Cost and Utilization Project Nationwide Inpatient Sample (NIS) from 2002-2011. Parathyroidectomies for primary hyperparathyroidism were identified using International Classification of Diseases, Ninth Revision codes. Unadjusted and age- and sex- adjusted rates of inpatient parathyroidectomy for primary hyperparathyroidism were derived from the NIS and the annual US Census. We estimated 109,583 parathyroidectomies for primary hyperparathyroidism between 2002 and 2011. More than half (55.4%) of patients were younger than age 65, and more than three-quarters (76.8%) were female. The overall rate of inpatient parathyroidectomy was 32.3 cases per million person-years. The adjusted rate decreased from 2004 (48.3 cases/million person-years) to 2007 (31.7 cases/million person-years) and was sustained thereafter. Although inpatient parathyroidectomy rates declined over time across all geographic regions, a steeper decline was observed in the South compared to other regions. Overall in-hospital mortality rates were 0.08%: 0.02% in patients younger than 65 years and 0.14% in patients 65 years and older. Inpatient parathyroidectomy rates for primary hyperparathyroidism have declined in recent years.

  View details for DOI 10.1371/journal.pone.0161192

  View details for PubMedID 27529699

• Quality of life and hypertension after hormone therapy withdrawal in New York City MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY Warren, M. P., Richardson, O., Chaudhry, S., Shu, A. D., Swica, Y., Sims, V. R., Sloan, N. L. 2013; 20 (12): 1255-1263

  Abstract

  Many women stopped hormone therapy (HT) or estrogen therapy (ET) after the Women's Health Initiative results were published in 2002. This study assessed the incidence of hypertension, weight gain, and dyslipidemia; conditions that predispose to chronic diseases; medication use; and quality of life in women who used HT/ET for at least 5 years and subsequently stopped its use compared with those who continued its use.A retrospective study was conducted. All consenting eligible women (aged 56-73 y) in physicians' offices were interviewed, and measurements of weight, height, waist-to-hip ratio, and body fat were performed. Standardized quality-of-life and menopausal and medical questionnaires were administered. Three groups were compared: group 1, women who have remained on HT/ET; group 2, women who have resumed HT/ET after stopping for at least 6 months; and group 3, women who have stopped HT/ET and have not resumed.One hundred fifty-nine women were enrolled in group 1, 43 women were enrolled in group 2, and 108 women were enrolled in group 3. Women's characteristics were similar, except that group 3 was 1.5 (0.5) years older and had 4.4 (0.7) years less HT/ET use than groups 1 and 2. Utian Quality of Life scores were significantly lower in group 3 (83.4 [12.5]) than in groups 1 and 2 (87.6 [13.3], P < 0.02), particularly in the occupational satisfaction scale. About 16.6% and 16.3% of women in groups 1 and 2 were on antihypertensive medication, respectively, compared with 27.4% in group 3 (P < 0.04).Discontinuation of HT/ET may predispose some women to the risk of hypertension and may affect their quality of life.

  View details for DOI 10.1097/gme.0b013e31828cfd3b

  View details for Web of Science ID 000330465700007

  View details for PubMedID 23571529

• Trabecular and Cortical Microarchitecture in Postmenopausal HIV-Infected Women CALCIFIED TISSUE INTERNATIONAL Yin, M. T., Shu, A., Zhang, C. A., Boutroy, S., McMahon, D. J., Ferris, D. C., Colon, I., Shane, E. 2013; 92 (6): 557-565

  Abstract

  Our objective was to assess the effects of HIV infection and antiretroviral therapy on trabecular and cortical microarchitecture in postmenopausal minority women. A subgroup of 106 (46 HIV-infected, 60 uninfected) postmenopausal Hispanic and African American women from an established cohort had areal bone mineral density (aBMD) measured by dual-energy X-ray absorptiometry and trabecular and cortical volumetric BMD (vBMD) and microarchitecture measured by high-resolution peripheral quantitative computed tomography (HRpQCT) at the radius and tibia. HIV-infected women were slightly younger (58 ± 1 vs. 61 ± 1 years, p = 0.08), and had lower body mass index (BMI; 28 ± 1 vs. 32 ± 1 kg/m(2), p < 0.01). BMI-adjusted aBMD Z scores were lower in HIV-infected women at the lumbar spine, total hip, and ultradistal radius. Serum N-telopeptide and C-telopeptide levels were also higher in HIV-infected women. Trabecular and cortical vBMD were similar at the radius, but cortical area (105.5 ± 2.4 vs. 120.6 ± 2.0 mm(2), p < 0.01) and thickness (956 ± 33 vs. 1,075 ± 28 μm, p < 0.01) at the tibia were approximately 11-12 % lower in HIV-infected women. Differences remained significant after adjusting for age, BMI, and race/ethnicity. In contrast, cortical porosity was similar in the two groups. Although HIV-infected postmenopausal women had lower aBMD at the spine, total hip, and ultradistal radius and higher levels of bone resorption markers, the only differences detected by HRpQCT were lower cortical thickness and area at the tibia.

  View details for DOI 10.1007/s00223-013-9716-8

  View details for Web of Science ID 000319021400008

  View details for PubMedID 23460340

  View details for PubMedCentralID PMC3656136

• TRABECULAR AND CORTICAL MICROARCHITECTURE IN POSTMENOPAUSAL HIV-INFECTED WOMEN Yin, M. T., Shu, A., Zhang, C. A., Boutroy, S., McMahon, D. J., Ferris, D. C., Colon, I., Shane, E. SPRINGER LONDON LTD. 2012: S211–S212

  View details for Web of Science ID 000309259600305

• Bone structure and turnover in type 2 diabetes mellitus OSTEOPOROSIS INTERNATIONAL Shu, A., Yin, M. T., Stein, E., Cremers, S., Dworakowski, E., Ives, R., Rubin, M. R. 2012; 23 (2): 635-641

  Abstract

  We compared skeletal parameters in type 2 diabetic (T2DM) and non-diabetic postmenopausal women. Bone structure by dual energy x-ray absorptiometry (DXA) and HR-pQCT was not different, although procollagen type 1 amino-terminal propeptide (P1NP) and osteocalcin levels were lower in T2DM.T2DM is associated with increased fracture risk, but, paradoxically, with higher cross-sectional bone density (BMD) as measured by DXA. We sought explanations to this puzzle by investigating detailed structural and biochemical skeletal parameters in T2DM.Cross-sectional comparison of 25 postmenopausal T2DM women and 25 matched controls using DXA, high-resolution peripheral quantitative computed tomography (HR-pQCT) and biochemical bone turnover markers.BMD by DXA did not differ between T2DM and controls. HR-pQCT assessment also did not differ, with the exception of cortical area at the tibia, which tended to be lower in the diabetics (difference of 12 ± 6 [mean ± SD] mm, p = 0.06). P1NP and osteocalcin levels were lower in T2DM as compared to controls (P1NP, 34.3 ± 16 vs. 57.3 ± 28 ng/ml; p = 0.005; osteocalcin, 4.5 ± 2 vs. 6.2 ± 2 nmol/L; p = 0.001).Postmenopausal women with T2DM had lower levels of bone formation markers as compared to controls. Aside from a possible decrease in cortical bone area at a weight-bearing site, bone structure was not altered in T2DM. Lower bone turnover may be a skeletal parameter that is present in T2DM.

  View details for DOI 10.1007/s00198-011-1595-0

  View details for Web of Science ID 000299306300024

  View details for PubMedID 21424265

• Effect of Estrogen and Hormone Therapy Withdrawal on Health and Quality of Life after Publication of The Women's Health Initiative in New York City Warren, M., Richardson, O., Chaudluy, S., Shu, A., Chua, A., Sloan, N. L. LIPPINCOTT WILLIAMS & WILKINS. 2011: 1342

  View details for Web of Science ID 000297914800043

• Vitamin D deficiency in HIV-infected postmenopausal Hispanic and African-American women OSTEOPOROSIS INTERNATIONAL Stein, E. M., Yin, M. T., McMahon, D. J., Shu, A., Zhang, C. A., Ferris, D. C., Colon, I., Dobkin, J. F., Hammer, S. M., Shane, E. 2011; 22 (2): 477-487

  Abstract

  We evaluated vitamin D status in HIV+ and HIV- postmenopausal African-American (AA) and Hispanic women. Most women (74-78%) had insufficient 25-hydroxyvitamin D (25OHD) levels, regardless of HIV status. 25OHD was lower in AA women and women lacking supplement use, providing support for screening and supplementation. Among HIV+ women, 25OHD was associated with current CD4 but not type of antiretroviral therapy.To evaluate vitamin D status and factors associated with vitamin D deficiency and insufficiency in HIV-infected (HIV+) postmenopausal minority women.In this cross-sectional study, 89 HIV+ and 95 HIV- postmenopausal women (33% AA and 67% Hispanic) underwent assessment of 25OHD, 1,25-dihydroxyvitamin D, parathyroid hormone, markers of bone turnover and bone mineral density by dual energy X-ray absorptiometry.The prevalence of low 25OHD did not differ by HIV status; the majority of both HIV+ and HIV- women (74-78%) had insufficient levels (<30 ng/ml). Regardless of HIV status, 25OHD was significantly lower in AA subjects, and higher in subjects who used both calcium and multivitamins. In HIV+ women on antiretroviral therapy (ART), 25OHD was directly associated with current CD4 count (r=0.32; p<0.01) independent of age, ethnicity, BMI, or history of AIDS-defining illness. No association was observed between 1,25(OH)(2)D and CD4 count or between serum 25OHD, 1,25(OH)(2)D or PTH and type of ART.In postmenopausal minority women, vitamin D deficiency was highly prevalent and associated with AA race and lack of supplement use, as well as lower current CD4 cell count. These results provide support for screening and repletion of vitamin D in HIV+ patients.

  View details for DOI 10.1007/s00198-010-1299-x

  View details for Web of Science ID 000286207800008

  View details for PubMedID 20585939

• Low Bone Mass and High Bone Turnover in Postmenopausal Human Immunodeficiency Virus-Infected Women JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM Yin, M. T., McMahon, D. J., Ferris, D. C., Zhang, C. A., Shu, A., Staron, R., Colon, I., Laurence, J., Dobkin, J. F., Hammer, S. M., Shane, E. 2010; 95 (2): 620-629

  Abstract

  Low bone mineral density (BMD) is commonly reported in young men and women with HIV infection, and fracture rates may be higher. With effective antiretroviral therapy (ART), the HIV population is aging. However, little is known about the skeletal status of postmenopausal women.We aimed to assess the effects of HIV infection and ART on BMD and bone turnover in postmenopausal minority women.A prospective cohort study was performed in 92 HIV+ and 95 HIV- postmenopausal Hispanic and African-American women.We measured BMD by dual-energy x-ray absorptiometry, fracture prevalence, serum levels of inflammatory cytokines (TNFalpha, IL-6), bone turnover markers, calciotropic hormones, and estrone.HIV+ women were younger (56 +/- 1 vs. 60 +/- 1 yr; P < 0.01) and had lower BMI (28 +/- 1 vs. 30 +/- 1 kg/m(2); P < 0.01) and estrone levels. Prevalence of T scores below -1.0 was greater in HIV+ women at the spine (78 vs. 64%; P < 0.05), total hip (45 vs. 29%; P < 0.05), and femoral neck (64 vs. 46%; P < 0.05), and Z scores adjusted for BMI were lower in HIV+ women at the same sites. Serum TNFalpha, N-telopeptide, and C-telopeptide were significantly higher in HIV+ than HIV- women, particularly those receiving ART. HIV+ status was independently and negatively associated with spine and hip BMD after adjustment for age, ethnicity, BMI, and alcohol.The lower BMD, higher prevalence of low BMD, and higher levels of bone turnover markers detected in HIV+ postmenopausal minority women could place them at high risk for future fractures.

  View details for DOI 10.1210/jc.2009-0708

  View details for Web of Science ID 000274298200022

  View details for PubMedID 19965927

  View details for PubMedCentralID PMC2840861

• Adherence to Osteoporosis Medications After Patient and Physician Brief Education: Post Hoc Analysis of a Randomized Controlled Trial AMERICAN JOURNAL OF MANAGED CARE Shu, A. D., Stedman, M. R., Polinski, J. M., Jan, S. A., Patel, M., Truppo, C., Breiner, L., Chen, Y., Weiss, T. W., Solomon, D. H. 2009; 15 (7): 417-424

  Abstract

  To examine whether adherence to osteoporosis medications can be improved by educational interventions targeted at primary care physicians (PCPs) and patients.Post hoc analysis of data collected as part of a prospective randomized controlled trial to improve initiation of osteoporosis management such as bone mineral density testing or osteoporosis drug initiation.The trial was conducted among patients at risk for osteoporosis enrolled in Horizon Blue Cross Blue Shield of New Jersey. For a 3-month period, randomly selected PCPs and their patients received education about osteoporosis diagnosis and treatment. The PCPs received face-to-face education by trained pharmacists, while patients received letters and automated telephone calls. The control group received no education. We assessed medication adherence during 10 months following the start of the intervention using the medication possession ratio (MPR), the ratio of available medication to the total number of days studied.These analyses included 1867 patients (972 randomized to the intervention group and 875 to the control group) and their 436 PCPs. During 10 months following the intervention, the median MPRs were 74% (interquartile range [IQR], 19%-93%) for the intervention group and 73% (IQR, 0%-93%) for the control group (P = .18). The median times until medication discontinuation after the intervention were 85 days (IQR, 58-174 days) for the intervention group and 79 days (IQR, 31-158 days) for the control group.The educational intervention did not significantly improve medication compliance or persistence with osteoporosis drugs.

  View details for Web of Science ID 000268159100002

  View details for PubMedID 19589009

  View details for PubMedCentralID PMC2885859