Oral Treatment With Bisphosphonates of Osteoporosis Does Not Increase the Risk of Severe Gastrointestinal Side Effects: A Meta-Analysis of Randomized Controlled Trials

Dömötör, Zsuzsa Réka; Vörhendi, Nóra; Hanák, Lilla; Hegyi, Péter; Kiss, Szabolcs; Csiki, Endre; Szakó, Lajos; Párniczky, Andrea

doi:10.3389/fendo.2020.573976

Cited by 15 publications

(9 citation statements)

References 70 publications

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“…Intravenous bisphosphonates can give fever and in uenza-like symptoms after the rst infusion, which are believed to occur due to their ability to activate human γδ T cells. These symptoms do not recur with subsequent infusions (10) . One study estimated several of atrial brillation cases might have been due to alendronate use.…”

Section: Side Effectsmentioning

confidence: 84%

“Dental Consideration in Patients Under Bisphosphonate and Radiotherapy: Systematic Review”

AlSahman

AlSahman²,

Alturiaki

2022

Preprint

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Background: Medication-related osteonecrosis of the jaw is defined as the necrosis of jawbone cells in patients who are on drugs known to increase the risk of the disease. The condition may lead to several complications in oral cavity. Osteoradionecrosis is a serious complication of radiotherapy for head and neck cancer. Radioactive osteonecrosis most commonly occurs in the mouth during treatment of head and neck cancer and can appear up to 5 years after radiation. The aim of current systematic review was highlighted on the dental consideration after and during radiotherapy and treatment of bisphosphonate. Methodology: The present Systematic review conducted to relevant recent articles that detected and identified through the journals databases (PUBMED, EMBASE, and MEDLINE) between the year 01 January 2015 to 01 May 2022. A search was achieved by using the specific keywords terms Dental care; Dental management; bisphosphonate-related osteonecrosis of the jaw (BRONJ); Osteoradionecrosis; Bisphosphonate; and Radiotherapy. Results: The current systematic review conducted to 18 articles published after 2015s, most articles were highlighted on Head and neck cancer with low sample size, and osteonecrosis condition during Bisphosphate therapy. The results showed significant Osteoradionecrosis effect of radiotherapy on jawbone characterized by non-healing socket after extraction, loosening of teeth, exposed oral cavity bone, poor healing and infection of soft tissue, numbness, or the feeling of heaviness in the jaw and exudate discharge. As well as the results showed negative osteonecrosis effect of BP therapy on the jawbone during therapy characterized by change of tooth structure. Conclusion: HNC patients should have comprehensive dental examination before undergoing to radiotherapy, as well as clearance before start bisphosphates, also dentist Should be highly educated and skilled in managing oral disease and minimize the high risk of complications.

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Section: Side Effectsmentioning

confidence: 84%

“Dental Consideration in Patients Under Bisphosphonate and Radiotherapy: Systematic Review”

AlSahman

AlSahman²,

Alturiaki

2022

Preprint

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“…Oral bisphosphonates can be associated with upper GI adverse effects that are commonly reported as the primary reason for treatment discontinuation . Notably, pooled analyses of RCTs suggested either no increase or a slight increase in mild GI adverse effects (eg, acid reflux and esophageal irritation) and no increase in severe GI adverse effects (eg, esophageal ulcers or esophagitis) . Differences between RCTs and clinical experience may reflect selection bias (eg, participants in clinical trials may be healthier) or a high background incidence of GI problems in the general population .…”

Section: Discussionmentioning

confidence: 99%

Time to Benefit of Bisphosphonate Therapy for the Prevention of Fractures Among Postmenopausal Women With Osteoporosis

et al. 2022

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IMPORTANCEThe clinical decision to initiate bisphosphonate therapy for the treatment of osteoporosis requires balancing shorter-term harms and burdens (eg, gastroesophageal irritation or severe musculoskeletal pain) with longer-term benefits in reducing potential fractures.OBJECTIVE To assess the time to benefit (TTB) of bisphosphonate therapy for the prevention of nonvertebral and other fractures among postmenopausal women with osteoporosis.DATA SOURCES Randomized clinical trials (RCTs) were identified from systematic reviews commissioned by the US Preventive Services Task Force (1 review), the Agency for Healthcare Research and Quality (1 review), the Cochrane Library (2 reviews), and the Endocrine Society (1 review).STUDY SELECTION Studies selected were RCTs involving postmenopausal women with a diagnosis of osteoporosis based on existing vertebral fractures or bone mineral density T scores of −2.5 or lower. The selection process was focused on studies of alendronate, risedronate, and zoledronic acid because they are guideline-recommended first-line agents for reducing nonvertebral fractures. Studies were excluded if they did not focus on women with a primary diagnosis of osteoporosis, had no placebo arm, or had a lack of data on time to fracture.DATA EXTRACTION AND SYNTHESIS Random-effects Weibull survival curves were fitted and Markov chain Monte Carlo methods were used to estimate the absolute risk reduction (ARR) and TTB for each study. These estimates were pooled using a random-effects meta-analysis model. MAIN OUTCOMES AND MEASURESThe primary outcome was the time to 3 different ARR thresholds (0.002, 0.005, and 0.010) for the first nonvertebral fracture. Secondary outcomes included the time to 4 ARR thresholds (0.001, 0.002, 0.005, and 0.010) for hip fracture, any clinical fracture, and clinical vertebral fracture. RESULTSOf 67 full-text articles identified, 10 RCTs comprising 23 384 postmenopausal women with osteoporosis were included either as the original RCT or part of subsequently published pooled analyses. Among the studies, the number of participants ranged from 994 to 7765, with mean (SD) age ranging from 63 (7) years to 74 (3) years and follow-up duration ranging from 12 to 48 months. The pooled meta-analysis found that 12.4 months (95% CI, 6.3-18.4 months) were needed to avoid 1 nonvertebral fracture per 100 postmenopausal women receiving bisphosphonate therapy at an ARR of 0.010. To prevent 1 hip fracture, 200 postmenopausal women with osteoporosis would need to receive bisphosphonate therapy for 20.3 months (95% CI, 11.0-29.7 months) at an ARR of 0.005. In addition, 200 postmenopausal women with osteoporosis would need to receive bisphosphonate therapy for 12.1 months (95% CI, 6.4-17.8 months) to avoid 1 clinical vertebral fracture at an ARR of 0.005. CONCLUSIONS AND RELEVANCEThis meta-analysis found that the TTB of bisphosphonate therapy was 12.4 months to prevent 1 nonvertebral fracture per 100 postmenopausal women with osteoporosis. These results suggest that bisphosphonate therapy is most...

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“…However, Dömötör et al, in their most recent meta-analysis of 39,047 patients on bisphosphonate therapy, have reported that bisphosphonates do not produce significant adverse effects on the esophagus and other parts of the GIT (ref. 16 ).…”

Section: Drug Induced Esophageal Injurymentioning

confidence: 99%

Lesions in the oral cavity and esophagus caused by prescribed drugs: A review

Tešić-Rajković¹,

Radovanović-Dinić²

2022

BIOMED PAP

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Oral Treatment With Bisphosphonates of Osteoporosis Does Not Increase the Risk of Severe Gastrointestinal Side Effects: A Meta-Analysis of Randomized Controlled Trials

Cited by 15 publications

References 70 publications

“Dental Consideration in Patients Under Bisphosphonate and Radiotherapy: Systematic Review”

“Dental Consideration in Patients Under Bisphosphonate and Radiotherapy: Systematic Review”

Time to Benefit of Bisphosphonate Therapy for the Prevention of Fractures Among Postmenopausal Women With Osteoporosis

Lesions in the oral cavity and esophagus caused by prescribed drugs: A review

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