spinal fractures

RPR Commentary: Conservative treatment of patients with acute painful vertebral compression fractures should usually include NSAIDs and teriparatide. James W. Mold, MD, MPH

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Importance: Osteoporotic vertebral compression fractures (VCFs) frequently cause substantial pain and reduced mobility, posing a major health problem. Despite the critical need for effective pain management to restore functionality and improve patient outcomes, the value of various conservative treatments for acute VCF has not been systematically investigated.

Objective: To assess and compare different conservative treatment options in managing acute pain related to VCF.

Data sources: On May 16, 2023, 4 databases-PubMed, Embase, Scopus, and CINAHL-were searched. In addition, a gray literature search within Scopus and Embase was also conducted.

Study selection: Included studies were prospective comparative and randomized clinical trials that assessed conservative treatments for acute VCF.

Data extraction and synthesis: Data extraction and synthesis were performed by 2 authors according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Network Meta-Analyses recommendations. A frequentist graph-theoretical model and a random-effects model were applied for the meta-analysis.

Main outcomes and measures: Primary outcomes were short-term (4 weeks) pain during activity and long-term (latest available follow-up) nonspecified pain in patients with acute VCF.

Results: The study included 20 trials, encompassing 2102 patients, and evaluated various interventions for managing VCF. Calcitonin (standardized mean difference [SMD], -4.86; 95% CI, -6.87 to -2.86) and nonsteroidal anti-inflammatory drugs (NSAIDs; SMD, -3.94; 95% CI, -7.30 to -0.58) were beneficial regarding short-term pain during activity compared with placebo. For long-term nonspecific pain management, bisphosphonates were associated with inferior pain outcomes compared with daily (SMD, 1.21; 95% CI, 0.11 to 2.31) or weekly (SMD, 1.13; 95% CI, 0.05 to 2.21) administration of teriparatide, with no treatment being superior to NSAIDs. The qualitative analysis of adverse events highlighted that typical adverse events associated with these medications were observed.

Conclusions and relevance: NSAIDs and teriparatide may be the preferred treatment options for pain management in acute osteoporotic VCF. Although calcitonin also proved to be beneficial, its safety profile and potential adverse effects restrict its widespread application. The limited evidence on braces and analgesics underscores the urgent need for future research.

Author/s:

Assil-Ramin Alimy, Athanasios D Anastasilakis, John J Carey, Stella D'Oronzo, Anda M Naciu, Julien Paccou, Maria P Yavropoulou, Willem F Lems, Tim Rolvien

Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

Saige Blanchard — Tue, 07 Jun 2022 05:00:00 +0000

Date Added:

June 7, 2022

Journal/Publication:

Cochrane Database of Systematic Reviews

Publisher:

John Wiley & Sons, Ltd.

Publication Date:

May 3, 2022

URL:

Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1002/14651858.CD004523.pub4

Keywords

PMID (1):

35502787

MeSH

Risedronic Acid

spinal fractures

osteoporotic fractures

calcium

Drug Approval

A concise summary of a Cochrane Collaboration review of evidence of the effectiveness of risedronate for primary and secondary prevention of fractures. James W. Mold, MD, MPH

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Background: Osteoporosis is an abnormal reduction in bone mass and bone deterioration leading to increased fracture risk. Risedronate belongs to the bisphosphonate class of drugs which act to inhibit bone resorption by interfering with the activity of osteoclasts. This is an update of a Cochrane Review that was originally published in 2003.

Objectives: We assessed the benefits and harms of risedronate in the primary and secondary prevention of osteoporotic fractures for postmenopausal women at lower and higher risk for fractures, respectively.

Search methods: With broader and updated strategies, we searched the Cochrane Central Register of Control Trials (CENTRAL), MEDLINE and Embase. A grey literature search, including the online databases ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), and drug approval agencies, as well as bibliography checks of relevant systematic reviews was also performed. Eligible trials published between 1966 to 24 March 2021 were identified.

Selection criteria: We included randomised controlled trials that assessed the benefits and harms of risedronate in the prevention of fractures for postmenopausal women. Participants must have received at least one year of risedronate, placebo or other anti-osteoporotic drugs, with or without concurrent calcium/vitamin D. Major outcomes were clinical vertebral, non-vertebral, hip and wrist fractures, withdrawals due to adverse events, and serious adverse events. In the interest of clinical relevance and applicability, we classified a study as secondary prevention if its population fulfilled more than one of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, low bone mineral density (BMD)T score ≤ -2.5, and age ≥ 75 years old. If none of these criteria was met, the study was considered to be primary prevention.

Data collection and analysis: We used standard methodology expected by Cochrane. We pooled the relative risk (RR) of fractures using a fixed-effect model based on the expectation that the clinical and methodological characteristics of the respective primary and secondary prevention studies would be homogeneous, and the experience from the previous review suggesting that there would be a small number of studies. The base case included the data available for the longest treatment period in each placebo-controlled trial and a >15% relative change was considered clinically important. The main findings of the review were presented in summary of findings tables, using the GRADE approach. In addition, we looked at benefit and harm comparisons between different dosage regimens for risedronate and between risedronate and other anti-osteoporotic drugs.

Main results: Forty-three trials fulfilled the eligibility criteria, among which 33 studies (27,348 participants) reported data that could be extracted and quantitatively synthesized. We had concerns about particular domains of risk of bias in each trial. Selection bias was the most frequent concern, with only 24% of the studies describing appropriate methods for both sequence generation and allocation concealment. Fifty per cent and 39% of the studies reporting benefit and harm outcomes, respectively, were subject to high risk. None of the studies included in the quantitative syntheses were judged to be at low risk of bias in all seven domains. The results described below pertain to the comparisons for daily risedronate 5 mg versus placebo which reported major outcomes. Other comparisons are described in the full text. For primary prevention, low- to very low-certainty evidence was collected from four studies (one to two years in length) including 989 postmenopausal women at lower risk of fractures. Risedronate 5 mg/day may make little or no difference to wrist fractures [RR 0.48 ( 95% CI 0.03 to 7.50; two studies, 243 participants); absolute risk reduction (ARR) 0.6% fewer (95% CI 1% fewer to 7% more)] and withdrawals due to adverse events [RR 0.67 (95% CI 0.38 to 1.18; three studies, 748 participants); ARR 2% fewer (95% CI 5% fewer to 1% more)], based on low-certainty evidence. However, its preventive effects on non-vertebral fractures and serious adverse events are not known due to the very low-certainty evidence. There were zero clinical vertebral and hip fractures reported therefore the effects of risedronate for these outcomes are not estimable. For secondary prevention, nine studies (one to three years in length) including 14,354 postmenopausal women at higher risk of fractures provided evidence. Risedronate 5 mg/day probably prevents non-vertebral fractures [RR 0.80 (95% CI 0.72 to 0.90; six studies, 12,173 participants); RRR 20% (95% CI 10% to 28%) and ARR 2% fewer (95% CI 1% fewer to 3% fewer), moderate certainty], and may reduce hip fractures [RR 0.73 (95% CI 0.56 to 0.94); RRR 27% (95% CI 6% to 44%) and ARR 1% fewer (95% CI 0.2% fewer to 1% fewer), low certainty]. Both of these effects are probably clinically important. However, risedronate's effects are not known for wrist fractures [RR 0.64 (95% CI 0.33 to 1.24); three studies,1746 participants); ARR 1% fewer (95% CI 2% fewer to 1% more), very-low certainty] and not estimable for clinical vertebral fractures due to zero events reported (low certainty). Risedronate results in little to no difference in withdrawals due to adverse events [RR 0.98 (95% CI 0.90 to 1.07; eight studies, 9529 participants); ARR 0.3% fewer (95% CI 2% fewer to 1% more); 16.9% in risedronate versus 17.2% in control, high certainty] and probably results in little to no difference in serious adverse events [RR 1.00 (95% CI 0.94 to 1.07; six studies, 9435 participants); ARR 0% fewer (95% CI 2% fewer to 2% more; 29.2% in both groups, moderate certainty).

Authors' conclusions: This update recaps the key findings from our previous review that, for secondary prevention, risedronate 5 mg/day probably prevents non-vertebral fracture, and may reduce the risk of hip fractures. We are uncertain on whether risedronate 5mg/day reduces clinical vertebral and wrist fractures. Compared to placebo, risedronate probably does not increase the risk of serious adverse events. For primary prevention, the benefit and harms of risedronate were supported by limited evidence with high uncertainty.

Author/s:

Wells, G. A., Hsieh, S., Zheng, C., Peterson, J., Tugwell, P., Liu, W.

Interventional Treatments for Acute and Chronic Pain: Systematic Review

Bethie Seay — Mon, 13 Sep 2021 05:00:00 +0000

Date Added:

September 13, 2021

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.23970/AHRQEPCCER247

A review of the evidence regarding the use of vertebroplasty, kyphoplasty, and cool radiofrequency denervation for acute and chronic back pain.

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Objective. To evaluate the benefits and harms of selected interventional procedures for acute and chronic pain that are not currently covered by the Centers for Medicare & Medicaid Services (CMS) but are relevant for and have potential utility for use in the Medicare population, or that are covered by CMS but for which there is important uncertainty or controversy regarding use.

Data sources. Electronic databases (Ovid® MEDLINE®, PsycINFO®, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews) to April 12, 2021, reference lists, and submissions in response to a Federal Register notice.

Review methods. Using predefined criteria and dual review, we selected randomized controlled trials (RCTs) for 10 interventional procedures and conditions that evaluated pain, function, health status, quality of life, medication use, and harms. Random effects meta-analysis was conducted for vertebral compression fracture; otherwise, outcomes were synthesized qualitatively. Effects were classified as small, moderate, or large using previously defined criteria.

Results. Thirty-seven randomized trials (in 48 publications) were included. Vertebroplasty (13 trials) is probably more effective at reducing pain and improving function in older (>65 years of age) patients, but benefits are small (less than 1 point on a 10-point pain scale). Benefits appear smaller (but still present) in sham-controlled (5 trials) compared with usual care controlled trials (8 trials) and larger in trials of patients with more acute symptoms; however, testing for subgroup effects was limited by imprecision. Vertebroplasty is probably not associated with increased risk of incident vertebral fracture (10 trials). Kyphoplasty (2 trials) is probably more effective than usual care for pain and function in older patients with vertebral compression fracture at up to 1 month (moderate to large benefits) and may be more effective at >1 month to ≥1 year (small to moderate benefits) but has not been compared against sham therapy. Evidence on kyphoplasty and risk of incident fracture was conflicting. In younger (below age for Medicare eligibility) populations, cooled radiofrequency denervation for sacroiliac pain (2 trials) is probably more effective for pain and function versus sham at 1 and 3 months (moderate to large benefits). Cooled radiofrequency for presumed facet joint pain may be similarly effective versus conventional radiofrequency, and piriformis injection with corticosteroid for piriformis syndrome may be more effective than sham injection for pain. For the other interventional procedures and conditions addressed, evidence was too limited to determine benefits and harms.

Conclusions. Vertebroplasty is probably effective at reducing pain and improving function in older patients with vertebral compression fractures; benefits are small but similar to other therapies recommended for pain. Evidence was too limited to separate effects of control type and symptom acuity on effectiveness of vertebroplasty. Kyphoplasty has not been compared against sham but is probably more effective than usual care for vertebral compression fractures in older patients. In younger populations, cooled radiofrequency denervation is probably more effective than sham for sacroiliac pain. Research is needed to determine the benefits and harms of the other interventional procedures and conditions addressed in this review.

Author/s:

Chou, R., Fu, R., Dana, T., Pappas, M., Hart, E., Mauer, K. M.

Osteoporosis Screening in Younger Postmenopausal Women

Brian Desmarais — Sat, 11 Jan 2020 20:19:49 +0000

Date Added:

January 11, 2020

Journal/Publication:

Journal of the American Medical Association

Publication Date:

January 9, 2020

URL:

Osteoporosis Screening in Younger Postmenopausal Women

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

doi:10.1001/jama.2019.18343

Keywords

MeSH

osteoporotic fractures

This is a nice review of when to consider screening for osteoporosis in postmenopausal women younger than 65. James W. Mold, MD, MPH

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Osteoporotic fractures, especially hip fractures, are associated with mobility limitations, chronic disability, loss of independence, and reduced quality of life.

Several randomized trials have demonstrated the benefit of drug treatment in reducing clinical fractures among postmenopausal women with existing vertebral fractures or bone mineral density (BMD) T-scores of −2.5 or lower and among adults aged 50 years and older with recent hip fracture.

Thus, osteoporosis in the clinical setting should be diagnosed in patients with a history of hip or clinical vertebral fracture not due to excessive trauma, those with existing radiographic vertebral fractures, and those with a BMD T-score of −2.5 or lower at the hip (femoral neck or total hip) or lumbar spine. In the absence of a history of hip or vertebral fracture, osteoporosis screening is aimed at identifying individuals with a BMD T-score of −2.5 or lower because those individuals may be candidates for osteoporosis pharmacotherapy. The BMD T-score quantifies the difference (expressed in standard deviations) between a patient’s BMD and the average BMD of young adult white women (reference group).

Author/s:

Crandall, C.J., Ensrud, Kristine E.