Open-label clinical trial of alendronate after teriparatide therapy in people with spinal cord injury and low bone mineral density.

STUDY DESIGN: Non-randomized open-label clinical trial of oral alendronate after teriparatide therapy in people with spinal cord injury (SCI) and low bone mineral density (BMD). OBJECTIVES: To determine if alendronate would prevent bone loss after discontinuation of teriparatide. SETTING: Outpatient research clinic at Northwestern University Feinberg School of Medicine. METHODS: Seventeen participants with chronic SCI who recently completed 12-24 months of teriparatide treatment received oral alendronate 70 mg once weekly for 12 months. Participants were evaluated at baseline, 6 months and 12 months. Bone was assessed by: DXA at the spine and hip, CT at the distal femur/proximal tibia, serum collected for bone markers, and bone strength determined by finite element (FE) analysis of the proximal tibia. RESULTS: Areal BMD showed no significant change from baseline at the total hip or femoral neck, where mean change (SD) was 1.3% (4.7) and 0.54% (5.0), respectively. However, areal BMD increased significantly at the spine by 2.5% (4.6). CT demonstrated significant increases in bone mineral content at the femoral epiphysis, metaphysis, and diaphysis, 15% (18), 7.7% (12), and 3.0% (3.5), respectively. Measurements at the tibia illustrated improvements and reductions, but no changes to FE-predicted strength were observed. Biomarkers illustrated inhibition of bone formation and resorption, with P1NP and CTX decreasing by 52% (82) and 62% (74), respectively. CONCLUSION: Twelve months of alendronate after discontinuation of teriparatide in people with SCI can prevent bone loss and may increase bone mass and preserve bone strength at the spine, hip, and some sites of the knee.

Self-Managing Postoperative Pain with the Use of a Novel, Interactive Device: A Proof of Concept Study.

Background. Pain is commonly experienced following surgical procedures. Suboptimal management is multifactorial. Objectives. The primary objective was to assess whether patients used a device (Navimed) to self-report pain over and above a normal baseline of observations. Secondary outcome measures included comparison of pain scores and patient use of and feedback on the device. Methods. In a prospective randomized controlled trial, elective gynaecological surgery patients received standard postoperative pain care or standard care plus the Navimed, which allowed them to self-report pain and offered interactive self-help options. Results. 52 female patients, 26 in each of device and standard groups, did not differ in the frequency of nurse-documented pain scores or mean pain scores provided to nurses. The device group additionally reported pain on the device (means 18.50 versus 11.90 pain ratings per day, t(32) = 2.75, p < 0.001) that was significantly worse than reported to nurses but retrospectively rated significantly less anxiety. 80% of patients found the device useful. Discussion and Conclusion. This study demonstrates that patients used the Navimed to report pain and to help manage it. Further work is required to investigate the difference in pain scores reported and to develop more sophisticated software.

Predictors of size for gestational age in St. Louis City and County.

OBJECTIVE: To identify social, behavioral, and physiological risk factors associated with small for gestational age (SGA) by gestational age category in St. Louis City and County. METHODS: A retrospective cohort study was conducted using birth certificate and fetal death records from 2000 to 2009 (n = 142,017). Adjusted associations of risk factors with SGA were explored using bivariate logistic regression. Four separate multivariable logistic regression analyses, stratified by gestational age, were conducted to estimate adjusted odds ratios. RESULTS: Preeclampsia and inadequate weight gain contributed significantly to increased odds for SGA across all gestational age categories. The point estimates ranged from a 3.41 increased odds among women with preeclampsia and 1.76 for women with inadequate weight gain at 24-28 weeks' gestational age to 2.19 and 2.11 for full-term infants, respectively. Among full-term infants, smoking (aOR = 2.08), chronic hypertension (aOR = 1.46), and inadequate prenatal care (aOR = 1.25) had the next most robust and significant impact on SGA. CONCLUSION: Preeclampsia and inadequate weight gain are significant risk factors for SGA, regardless of gestational age. Education on the importance of nutrition and adequate weight gain during pregnancy is vital. In this community, disparities in SGA and smoking rates are important considerations for interventions designed to improve birth outcomes.