The use of alkaline phosphatase as a bone turnover marker after spinal cord injury: A scoping review of human and animal studies.

BACKGROUND: Serum alkaline phosphatase (ALP) is measured as an indicator of bone or liver disease. Bone-specific alkaline phosphatase (B-ALP) is an isoform of ALP found in the bone tissue which can predict fractures and heterotopic ossification. OBJECTIVE: The aim of this scoping review was to explore the current use of ALP and B-ALP in studies using humans or animal models of SCI, and to identify ways to advance future research using ALP and B-ALP as a bone marker after SCI. RESULTS: HUMAN STUDIES: 42 studies were included. The evidence regarding changes or differences in ALP levels in individuals with SCI compared to controls is conflicting. For example, a negative correlation between B-ALP and total femur BMD was observed in only one of three studies examining the association. B-ALP seemed to increase after administration of teriparatide, and to decrease after treatment with denosumab. The effects of exercise on ALP and B-ALP levels are heterogeneous and depend on the type of exercise performed. ANIMAL STUDIES: 11 studies were included. There is uncertainty regarding the response of ALP or B-ALP levels after SCI; levels increased after some interventions, including vibration protocols, curcumin supplementation, cycles in electromagnetic field or hyperbaric chamber. Calcitonin or bisphosphonate administration did not affect ALP levels. CONCLUSION: Researchers are encouraged to measure the bone-specific isoform of ALP rather than total ALP in future studies in humans of animal models of SCI.

Effect of yoga on health-related outcomes in people at risk of fractures: a systematic review.

We summarized the effects of yoga on health-related outcomes and adverse events in men and postmenopausal women ≥50 years-old at increased risk of fracture, to inform the updated Osteoporosis Canada clinical practice guidelines. Six databases were searched for observational studies, randomized controlled trials and case series. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation handbook. Nine studies were included and reported using narrative syntheses due to the limited available evidence. Overall, the available evidence was of very low certainty. There was no effect of yoga on health-related quality of life in randomized trials. Effects on other health-related outcomes were mixed or not available in the literature. Five studies reported no adverse events directly related to the study intervention, and 2 studies did not report whether adverse events occurred. However, 2 case series reported vertebral fractures related to yoga participation, possibly due to excessive spinal flexion. Due to the limited and very low certainty evidence, guideline developers will need to draw indirect evidence from yoga studies among middle aged or older adults that are not at fracture risk. PROSPERO: CRD42019124898. Novelty: Evidence in general was of very low certainty. Yoga had no effect on health-related quality of life in randomized trials. Evidence was mixed or unavailable for other outcomes. Case studies reported yoga poses involving spinal flexion coincided with incidents of vertebral compression fracture among older adults with increased fracture risk.

Balance and functional training and health in adults: an overview of systematic reviews.

This overview of systematic reviews examined the effect of balance and functional strength training on health outcomes in adults aged 18 years or older, to inform the Canadian 24-hour Movement Guidelines. Four electronic databases were searched for systematic reviews published between January 2009 and May 2019. Eligibility criteria were determined a priori for population (community-dwelling adults), intervention (balance and functional training), comparator (no intervention or different types/doses), and outcomes (critical: falls and fall-related injuries; adverse events; important: physical functioning and disability; health-related quality of life; physical activity; and sedentary behaviour). Two reviewers independently screened studies for eligibility and performed AMSTAR 2 assessment. One review was selected per outcome. Of 3288 records and 355 full-text articles, 5 systematic reviews were included, encompassing data from 15 890 participants in 23 countries. In adults 65 years and older, balance and functional training and Tai Chi reduced the rate of falls and the number of people who fell, and improved aspects of physical functioning and physical activity. The effect on health-related quality of life and falls requiring hospitalization was uncertain. While inconsistently monitored, only 1 serious adverse event was reported. No evidence was available in adults under age 65 years. Included systematic reviews and primary evidence reported by review authors ranged in quality. Overall, participation in balance and functional training reduced falls and improved health outcomes in adults 65 years of age and older. PROSPERO registration no.: CRD42019134865. Novelty This overview informs updated guidelines for balance training in adults. Balance and functional training reduced falls and improved health outcomes.

Evaluating the efficacy of functional electrical stimulation therapy assisted walking after chronic motor incomplete spinal cord injury: effects on bone biomarkers and bone strength.

OBJECTIVES: To determine the efficacy of functional electrical stimulation therapy assisted walking (FES-T) compared to a conventional aerobic and resistance training (CONV) with respect to bone biomarkers and lower extremity bone strength outcomes among adults with chronic motor incomplete spinal cord injury (SCI). DESIGN: Parallel group randomized controlled trial ( www.clinicaltrials.gov - NCT0020196819). Site: Tertiary academic rehabilitation centre in Canada. METHODS: Adults with chronic (≥18 months) motor incomplete SCI (C2-T12 AIS C-D) were consented and randomized to FES-T or CONV training for 45 minutes thrice-weekly for 4 months. Osteocalcin (OC), ß-cross laps (CTX) and sclerostin were assessed at baseline, and 4 months. Similarly, total hip, distal femur and proximal tibia region bone mineral density (BMD) via DXA (4500A, Hologic Inc. Waltham, MA, USA) and tibia bone quality via pQCT (Stratec XCT-2000, Mezintecknik, Pforzheim, Germany) were assessed at baseline, 4, and 12 months. Between group differences were analyzed using repeated measures general linear models. RESULTS: Thirty-four participants (17 FES-T, 17 CONV) consented and were randomized, 27 participants completed the 4-month intervention and 12-month outcome assessments. Participants in the FES-T arm had a decrease in CTX and a significant increase in OC at intervention completion (P<0.05). Significant biomarker changes were not observed in the CONV group. No within or between group differences from baseline were observed in sclerostin or bone strength. CONCLUSIONS: Four months of FES-T improved bone turnover (increase in OC and decrease in CTX) but not bone strength among individuals with chronic SCI. Future, long term FES-T may augment lower extremity bone strength.

Suggestions for Adapting Yoga to the Needs of Older Adults with Osteoporosis.

BACKGROUND: Exercise such as yoga may have health benefits for older adults with osteoporosis, but without attention to safe movement yoga can also increase the risk for injury. OBJECTIVE: The current article provides suggestions for how to adapt yoga to the needs of older adults with osteoporosis. SUGGESTIONS: A general guidelines for exercise is that older adults with osteoporosis should participate in a multicomponent exercise program, including resistance and balance training. Contraindicated movements include end-range flexion/extension/rotation of the spine and internal/external rotation of the hip. Yoga postures that should be encouraged include postures emphasizing spinal alignment and extension to mid-range in standing and on the floor. Overarching considerations for participation in yoga are that classes should be designed for higher-risk older adults, led by an instructor who has had proper training with individuals with osteoporosis, should be a noncompetitive environment, and should give attention to which postures are safe and how to transition safely.

Successful knowledge translation intervention in long-term care: final results from the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial.

BACKGROUND: Few studies have systematically examined whether knowledge translation (KT) strategies can be successfully implemented within the long-term care (LTC) setting. In this study, we examined the effectiveness of a multifaceted, interdisciplinary KT intervention for improving the prescribing of vitamin D, calcium and osteoporosis medications over 12-months. METHODS: We conducted a pilot, cluster randomized controlled trial in 40 LTC homes (21 control; 19 intervention) in Ontario, Canada. LTC homes were eligible if they had more than one prescribing physician and received services from a large pharmacy provider. Participants were interdisciplinary care teams (physicians, nurses, consultant pharmacists, and other staff) who met quarterly. Intervention homes participated in three educational meetings over 12 months, including a standardized presentation led by expert opinion leaders, action planning for quality improvement, and audit and feedback review. Control homes did not receive any additional intervention. Resident-level prescribing and clinical outcomes were collected from the pharmacy database; data collectors and analysts were blinded. In addition to feasibility measures, study outcomes were the proportion of residents taking vitamin D (≥800 IU/daily; primary), calcium ≥500 mg/day and osteoporosis medications (high-risk residents) over 12 months. Data were analyzed using the generalized estimating equations technique accounting for clustering within the LTC homes. RESULTS: At baseline, 5,478 residents, mean age 84.4 (standard deviation (SD) 10.9), 71% female, resided in 40 LTC homes, mean size = 137 beds (SD 76.7). In the intention-to-treat analysis (21 control; 19 intervention clusters), the intervention resulted in a significantly greater increase in prescribing from baseline to 12 months between intervention versus control arms for vitamin D (odds ratio (OR) 1.82, 95% confidence interval (CI): 1.12, 2.96) and calcium (OR 1.33, 95% CI: 1.01, 1.74), but not for osteoporosis medications (OR 1.17, 95% CI: 0.91, 1.51). In secondary analyses, excluding seven nonparticipating intervention homes, ORs were 3.06 (95% CI: 2.18, 4.29), 1.57 (95% CI: 1.12, 2.21), 1.20 (95% CI: 0.90, 1.60) for vitamin D, calcium and osteoporosis medications, respectively. CONCLUSIONS: Our KT intervention significantly improved the prescribing of vitamin D and calcium and is a model that could potentially be applied to other areas requiring quality improvement. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01398527 . Registered: 19 July 2011.

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency.

BACKGROUND: Multi-channel surface functional electrical stimulation (FES) for walking has been used to improve voluntary walking and balance in individuals with spinal cord injury (SCI). OBJECTIVE: To investigate short- and long-term benefits of 16 weeks of thrice-weekly FES-assisted walking program, while ambulating on a body weight support treadmill and harness system, versus a non-FES exercise program, on improvements in gait and balance in individuals with chronic incomplete traumatic SCI, in a randomized controlled trial design. METHODS: Individuals with traumatic and chronic (≥18 months) motor incomplete SCI (level C2 to T12, American Spinal Cord Injury Association Impairment Scale C or D) were recruited from an outpatient SCI rehabilitation hospital, and randomized to FES-assisted walking therapy (intervention group) or aerobic and resistance training program (control group). Outcomes were assessed at baseline, and after 4, 6, and 12 months. Gait, balance, spasticity, and functional measures were collected. RESULTS: Spinal cord independence measure (SCIM) mobility sub-score improved over time in the intervention group compared with the control group (baseline/12 months: 17.27/21.33 vs. 19.09/17.36, respectively). On all other outcome measures the intervention and control groups had similar improvements. Irrespective of group allocation walking speed, endurance, and balance during ambulation all improved upon completion of therapy, and majority of participants retained these gains at long-term follow-ups. CONCLUSIONS: Task-oriented training improves walking ability in individuals with incomplete SCI, even in the chronic stage. Further randomized controlled trials, involving a large number of participants are needed, to verify if FES-assisted treadmill training is superior to aerobic and strength training.

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: effects on body composition.

OBJECTIVE: To evaluate the effects of functional electrical stimulation (FES)-assisted walking on body composition, compared to a non-FES exercise program in individuals with a spinal cord injury (SCI). DESIGN: Parallel-group randomized controlled trial. METHODS: Individuals with chronic (≥ 18 months) incomplete SCI (level C2 to T12, AIS C or D) were recruited and randomized to FES-assisted walking (intervention), or aerobic and resistance training (control) sessions thrice-weekly for 16 weeks. Whole body and leg lean mass and whole body fat mass, measured with dual-energy X-ray absorptiometry, and lower-limb muscle cross-sectional area (CSA) and fat CSA, measured with peripheral computed tomography were assessed at baseline, 4 months, and 12 months. Intention-to-treat analyses using repeated measures general linear models were used to assess between-group differences. RESULTS: Thirty-four individuals were randomized (17 per group); 27 remained at 12 months. There were no significant main effects of FES-assisted walking on body composition variables in intention-to-treat analyses with group means. There was a significant group-by-time interaction for muscle area from baseline to 12 months (P = 0.04). Intention-to-treat analysis of muscle area change scores between baseline and 12 months revealed a significant difference between groups (mean (SD) muscle area change score 212 (517) mm(s) for FES, -136 (268) mm(s) for control, P = 0.026). There were 13 side effects or adverse events deemed related to study participation (7 intervention, 5 control); most were resolved with modifications to the protocol. One fainting episode resulted in a hospital visit and study withdrawal. CONCLUSIONS: Thrice-weekly FES-assisted walking exercise over 4 months did not result in a change in body composition in individuals with chronic, motor incomplete C2 to T12 SCI (AIS classification C and D). However, longer-term follow-up revealed that it might maintain muscle area.

An interdisciplinary knowledge translation intervention in long-term care: study protocol for the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial.

BACKGROUND: Knowledge translation (KT) research in long-term care (LTC) is still in its early stages. This protocol describes the evaluation of a multifaceted, interdisciplinary KT intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into LTC care processes. METHODS AND DESIGN: The Vitamin D and Osteoporosis Study (ViDOS) is underway in 40 LTC homes (n = 19 intervention, n = 21 control) across Ontario, Canada. The primary objectives of this study are to assess the feasibility of delivering the KT intervention, and clinically, to increase the percent of LTC residents prescribed ≥800 IU of vitamin D daily. Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician. The target audience within each LTC home is the Professional Advisory Committee (PAC), an interdisciplinary team who meets quarterly. The key elements of the intervention are three interactive educational sessions led by an expert opinion leader, action planning using a quality improvement cycle, audit and feedback reports, nominated internal champions, and reminders/point-of-care tools. Control homes do not receive any intervention, however both intervention and control homes received educational materials as part of the Ontario Osteoporosis Strategy. Primary outcomes are feasibility measures (recruitment, retention, attendance at educational sessions, action plan items identified and initiated, internal champions identified, performance reports provided and reviewed), and vitamin D (≥800 IU/daily) prescribing at 6 and 12 months. Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications, and falls and fractures. Qualitative methods will examine the experience of the LTC team with the KT intervention. Homes are centrally randomized to intervention and control groups in blocks of variable size using a computer generated allocation sequence. Randomization is stratified by home size and profit/nonprofit status. Prescribing data retrieval and analysis are performed by blinded personnel. DISCUSSION: Our study will contribute to an improved understanding of the feasibility and acceptability of a multifaceted intervention aimed at translating knowledge to LTC practitioners. Lessons learned from this study will be valuable in guiding future research and understanding the complexities of translating knowledge in LTC.

A randomized controlled trial of vitamin D dosing strategies after acute hip fracture: no advantage of loading doses over daily supplementation.

BACKGROUND: There remains uncertainty regarding the appropriate therapeutic management of hip fracture patients. The primary aim of our study was to examine whether large loading doses in addition to daily vitamin D offered any advantage over a simple daily low-dose vitamin D regimen for increasing vitamin D levels. METHODS: In this randomized controlled study, patients over age 50 with an acute fragility hip fracture were enrolled from two hospital sites in Ontario, Canada. Participants were randomized to one of three loading dose groups: placebo; 50,000 IU vitamin D2; or 100,000 IU D2. Following a placebo/loading dose, all patients received a daily tablet of 1,000 IU vitamin D3 for 90 days. Serum 25-hydroxy vitamin D (25-OHD) was measured at baseline, discharge from acute care (approximately 4-weeks), and 3-months. RESULTS: Sixty-five patients were enrolled in the study (44% male). An immediate rise in 25-OHD occurred in the 100,000 group, however there were no significant differences in 25-OHD between the placebo, 50,000 and 100,000 loading dose groups after 4-weeks (69.3, 84.5, 75.6 nmol/L, p = 0.15) and 3-months (86.7, 84.2, 73.3 nmol/L, p = 0.09), respectively. At the end of the study, approximately 75% of the placebo and 50,000 groups had reached the target therapeutic range (75 nmol/L), and 44% of the 100,000 group. CONCLUSIONS: In correcting vitamin D insufficiency/deficiency in elderly patients with hip fracture, our findings suggest that starting with a lower daily dose of Vitamin D3 achieved similar results as providing an additional large loading dose of Vitamin D2. At the end of the study, all three groups were equally effective in attaining improvement in 25-OHD levels. Given that a daily dose of 1,000 IU vitamin D3 (with or without a loading dose) resulted in at least 25% of patients having suboptimal vitamin D status, patients with acute hip fracture may benefit from a higher daily dose of vitamin D. TRIAL REGISTRATION: Clinical Trials # NCT00424619.

What are the beliefs, attitudes and practices of front-line staff in long-term care (LTC) facilities related to osteoporosis awareness, management and fracture prevention?

BACKGROUND: Compared to the general elderly population, those institutionalized in LTC facilities have the highest prevalence of osteoporosis and subsequently have higher incidences of vertebral and hip fractures. The goal of this study is to determine how well nurses at LTC facilities are educated to properly administer bisphosphonates. A secondary question assessed was the nurse's and PSW's attitudes and beliefs regarding the role and benefits of vitamin D for LTC patients. METHODS: Eight LTC facilities in Hamilton were surveyed, and all nurses were offered a survey. A total 57 registered nurses were surveyed. A 21 item questionnaire was developed to assess existing management practices and specific osteoporosis knowledge areas. RESULTS: The questionnaire assessed the nurse's and personal support worker's (PSWs) education on how to properly administer bisphosphonates by having them select all applicable responses from a list of options. These options included administering the drug before, after or with meals, given with or separate from other medications, given with juice, given with or without water, given with the patient sitting up, or finally given with the patient supine. Only 52% of the nurses and 8.7% of PSWs administered the drug properly, where they selected the options: (given before meals, given with water, given separate from all other medications, and given in a sitting up position). If at least one incorrect option was selected, then it was scored as an inappropriate administration. Bisphosphonates were given before meals by 85% of nurses, given with water by 90%, given separately from other medication by 71%, and was administered in an upright position by 79%. Only 52% of the nurses and 8.7% of PSWs surveyed were administering the drug properly. Regarding the secondary question, of the 57 nurses surveyed, 68% strongly felt their patients should be prescribed vitamin D supplements. Of the 124 PSWs who completed the survey, 44.4% strongly felt their patients should be prescribed vitamin D supplementation. CONCLUSION: Bisphosphonates are quite effective in increasing the bone mineral density of LTC patients, and may reduce fracture rates, but it is only effective if properly administered. In our study, proper administration of bisphosphonate therapy was less than optimal. In summary, although the education of health providers has improved since the mid-1990's, this area still requires further attention and the subject of future quality assurance research.

Bone loss and muscle atrophy in spinal cord injury: epidemiology, fracture prediction, and rehabilitation strategies.

Individuals with spinal cord injury (SCI) often experience bone loss and muscle atrophy. Muscle atrophy can result in reduced metabolic rate and increase the risk of metabolic disorders. Sublesional osteoporosis predisposes individuals with SCI to an increased risk of low-trauma fracture. Fractures in people with SCI have been reported during transfers from bed to chair, and while being turned in bed. The bone loss and muscle atrophy that occur after SCI are substantial and may be influenced by factors such as completeness of injury or time postinjury. A number of interventions, including standing, electrically stimulated cycling or resistance training, and walking exercises have been explored with the aim of reducing bone loss and/or increasing bone mass and muscle mass in individuals with SCI. Exercise with electrical stimulation appears to increase muscle mass and/or prevent atrophy, but studies investigating its effect on bone are conflicting. Several methodological limitations in exercise studies with individuals with SCI to date limit our ability to confirm the utility of exercise for improving skeletal status. The impact of standing or walking exercises on muscle and bone has not been well established. Future research should carefully consider the study design, skeletal measurement sites, and the measurement techniques used in order to facilitate sound conclusions.