ABSTRACT
BACKGROUND: Low back pain is one of the most common symptoms of osteoporosis. The pain can seriously affect patients' mood and quality of life; it can also further aggravate bone loss, causing a serious social burden. Minodronate is an oral bisphosphonate that needs to be administered daily. It significantly reduces levels of bone turnover markers (BTMs) and rapidly improves symptoms of low back pain in patients with osteoporosis. Osteoporosis requires long-term treatment, and daily dosing reduces patient compliance. Minodronate has a better safety profile than other bisphosphonates. The objective of the trial is to explore the efficacy and safety of minodronate in the treatment of low back pain in postmenopausal osteoporosis patients. METHODS: This is a single-centre, randomized, open-label controlled trial with a 24-week duration. Seventy-two eligible patients will be randomly divided into 4 groups. Subjects will be randomized at a 1:1 ratio to receive either minodronate (1 mg/day) or alendronate (10 mg/day) every day; senior women (≥ 75 years old) and older women (< 75 years old) will be at a ratio of 1:2. The primary outcome is the time required for the visual analogue scale (VAS) score to decline by ≥ 10 from baseline. The secondary outcome is the changes in VAS scores from baseline, the frequency and dosage of rescue medication, BTMs, bone mineral density (BMD), and variations in upper gastrointestinal (GI) symptom scores from baseline (including heartburn, pain, and bloating). DISCUSSION: This study will provide objective evidence for the efficiency and safety of minodronate. Furthermore, it will be helpful to evaluate the quantitative relationship between BTMs and BMD in patients with osteoporosis under different ages. TRIAL REGISTRATION: This study protocol has been registered with ClinicalTrials.gov ID NCT05645289 ( https://clinicaltrials.gov/search?term=NCT05645289 ) on December 8, 2022. The registry name is Peking University Third Hospital. This study protocol was reviewed and approved by the Peking University Third Hospital Medical Science Research Ethics Committee (M2022465, 2022.08.09, V2.0). The results will be published in scientific peer-reviewed journals. TRIAL STATUS: The protocol was registered at ClinicalTrials.gov (registration number: NCT05645289). Recruitment has started in January 2023 and is still ongoing.
Subject(s)
Bone Density Conservation Agents , Diphosphonates , Imidazoles , Low Back Pain , Osteoporosis, Postmenopausal , Randomized Controlled Trials as Topic , Humans , Female , Osteoporosis, Postmenopausal/drug therapy , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/adverse effects , Bone Density Conservation Agents/administration & dosage , Aged , Diphosphonates/therapeutic use , Diphosphonates/adverse effects , Diphosphonates/administration & dosage , Treatment Outcome , Low Back Pain/drug therapy , Middle Aged , Imidazoles/therapeutic use , Imidazoles/adverse effects , Imidazoles/administration & dosage , Pain Measurement , Bone Density/drug effects , Alendronate/therapeutic use , Alendronate/adverse effects , Alendronate/administration & dosageSubject(s)
Bone Density Conservation Agents , Osteoporosis, Postmenopausal , Female , Humans , Bone Density/drug effects , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/adverse effects , Bone Density Conservation Agents/administration & dosage , Diphosphonates/therapeutic use , Diphosphonates/adverse effects , Diphosphonates/administration & dosage , Osteoporosis, Postmenopausal/drug therapyABSTRACT
PURPOSE: The effects of daily teriparatide (D-PTH, 20 µg/day), weekly high-dose teriparatide (W-PTH, 56.5 µg/week), or bisphosphonate (BP) on the vertebra and proximal femur were investigated using quantitative computed tomography (QCT). METHODS: A total of 131 postmenopausal women with a history of fragility fractures were randomized to receive D-PTH, W-PTH, or bisphosphonate (oral alendronate or risedronate). QCT were evaluated at baseline and after 18 months of treatment. RESULTS: A total of 86 participants were evaluated by QCT (Spine: D-PTH: 25, W-PTH: 21, BP: 29. Hip: PTH: 22, W-PTH: 21, BP: 32. Dropout rate: 30.5 %). QCT of the vertebra showed that D-PTH, W-PTH, and BP increased total vBMD (+34.8 %, +18.2 %, +11.1 %), trabecular vBMD (+50.8 %, +20.8 %, +12.2 %), and marginal vBMD (+20.0 %, +14.0 %, +11.5 %). The increase in trabecular vBMD was greater in the D-PTH group than in the W-PTH and BP groups. QCT of the proximal femur showed that D-PTH, W-PTH, and BP increased total vBMD (+2.8 %, +3.6 %, +3.2 %) and trabecular vBMD (+7.7 %, +5.1 %, +3.4 %), while only W-PTH and BP significantly increased cortical vBMD (-0.1 %, +1.5 %, +1.6 %). Although there was no significant increase in cortical vBMD in the D-PTH group, cortical bone volume (BV) increased in all three treatment groups (+2.1 %, +3.6 %, +3.1 %). CONCLUSIONS: D-PTH had a strong effect on trabecular bone of vertebra. Although D-PTH did not increase cortical BMD of proximal femur, it increased cortical BV. W-PTH had a moderate effect on trabecular bone of vertebra, while it increased both cortical BMD and BV of proximal femur. Although BP had a limited effect on trabecular bone of vertebra compared to teriparatide, it increased both cortical BMD and BV of proximal femur.
Subject(s)
Cancellous Bone , Diphosphonates , Femur , Postmenopause , Teriparatide , Tomography, X-Ray Computed , Humans , Teriparatide/administration & dosage , Teriparatide/therapeutic use , Teriparatide/pharmacology , Female , Aged , Femur/drug effects , Femur/diagnostic imaging , Femur/pathology , Cancellous Bone/drug effects , Cancellous Bone/diagnostic imaging , Cancellous Bone/pathology , Diphosphonates/administration & dosage , Diphosphonates/pharmacology , Diphosphonates/therapeutic use , Postmenopause/drug effects , Cortical Bone/drug effects , Cortical Bone/diagnostic imaging , Cortical Bone/pathology , Bone Density Conservation Agents/administration & dosage , Bone Density Conservation Agents/therapeutic use , Middle Aged , Bone Density/drug effects , Fractures, Bone/diagnostic imaging , Spine/diagnostic imaging , Spine/drug effectsABSTRACT
PURPOSE: A MASCC/ISOO Clinical Practice Statement (CPS) is aimed at generating a concise tool for clinicians that concentrates practical information needed for the management of oral complications of cancer patients. This CPS raises awareness to the prevention of medication-related osteonecrosis of the jaw (MRONJ) in patients with breast cancer treated with adjuvant bone-modifying agents (BMA). METHODS: This CPS was developed based on a critical evaluation of the literature followed by a structured discussion of a group of leading experts, members of the Oral Care Study Group of MASCC/ISOO. The information is presented in the form of succinct bullets and tables to generate a short manual about the best standard of care. RESULTS: In patients treated with adjuvant BMA, dento-alveolar surgery poses a moderate risk for MRONJ that ranges between the high risk for MRONJ in patients with metastatic breast cancer and the low risk for MRONJ in patients with osteoporosis. Existing MRONJ guidelines serve as a starting point for adjuvant BMA use. Urgent procedures should be delivered without delay using the accepted precautions to prevent MRONJ. If elective surgery is considered, the individual risk for MRONJ following surgery should be assessed according to common risk factors. CONCLUSION: Prevention of MRONJ in primary breast cancer patients treated with adjuvant BMA requires risk-benefit assessment; collaboration between the medical team, dental professional, and patient; and patient-specific tailored dental treatment planning. The patient should be informed about this risk. Additional research is needed to define optimal MRONJ care for this population.
Subject(s)
Bisphosphonate-Associated Osteonecrosis of the Jaw , Bone Density Conservation Agents , Breast Neoplasms , Humans , Breast Neoplasms/drug therapy , Female , Bone Density Conservation Agents/adverse effects , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Bisphosphonate-Associated Osteonecrosis of the Jaw/prevention & control , Bisphosphonate-Associated Osteonecrosis of the Jaw/etiology , Chemotherapy, Adjuvant/methods , Chemotherapy, Adjuvant/adverse effects , Risk Factors , Osteoporosis/drug therapy , Diphosphonates/adverse effects , Diphosphonates/administration & dosage , Diphosphonates/therapeutic useABSTRACT
OBJECTIVE: This study aimed to investigate the association of bisphosphonates with outcomes related to radiographic changes and pain in hip osteoarthritis (OA) over 4 years. METHODS: This study examined data from the Osteoarthritis Initiative (OAI), which included 4088 hips from 2057 participants. Bisphosphonate users were identified as those who reported usage at least three times, including at baseline and during the subsequent 1, 2, 3, and 4-year follow-up visits. Non-users were participants who did not use bisphosphonates in the 5 years preceding the baseline and at subsequent follow-up visits. Generalized estimating equations were performed to assess the association between bisphosphonate use and outcomes related to radiographic changes and pain in hip OA over a 4-year follow-up. RESULTS: The analysis revealed no statistically significant difference between bisphosphonate users and non-users concerning outcomes related to radiographic changes and pain in hip OA over 4 years. Specifically, the odds ratios for the incidence and transition of radiographic hip OA were 0.55 (95% Confidence Interval [CI]: 0.26 to 1.17) and 0.78 (95% CI: 0.47 to 1.28), respectively. Furthermore, the odds ratios for the development and resolution of frequent hip pain were 1.04 (95% CI: 0.76 to 1.42) and 0.99 (95% CI: 0.72 to 1.36), respectively. CONCLUSION: The findings from this longitudinal study do not suggest an association between bisphosphonate use and the prevention, slowing, or delay of development and transition of radiographic changes or pain in hip OA over a 4-year follow-up.
Subject(s)
Arthralgia , Bone Density Conservation Agents , Diphosphonates , Disease Progression , Hip Joint , Osteoarthritis, Hip , Pain Measurement , Humans , Female , Diphosphonates/therapeutic use , Diphosphonates/administration & dosage , Osteoarthritis, Hip/diagnostic imaging , Osteoarthritis, Hip/epidemiology , Aged , Bone Density Conservation Agents/therapeutic use , Middle Aged , Time Factors , Hip Joint/diagnostic imaging , Arthralgia/epidemiology , Arthralgia/diagnosis , Arthralgia/etiology , Treatment Outcome , Risk Factors , United States/epidemiology , Incidence , Longitudinal Studies , Prospective StudiesABSTRACT
THE AIM THE STUDY: To analyze the density of the mandible in cancer patients during treatment with zoledronic acid. MATERIALS AND METHODS: A retrospective cohort study included 45 patients with cancer aged 26-81 years (average age 55±12.88 years), of whom 14 patients had bone metastases (n=14) and took 4 mg of zolendronic acid once every 28 days. The patients underwent standard PET-CT examinations in the «whole body¼ mode, and the density of the mandible was examined on CT. Radiation therapy was performed by intracavitary administration of strontium 89 chloride; remote radiation therapy with cisplatin radiomodification. In the presence of bone metastases, patients received complex supportive therapy with zolendronic acid. The effect of zolendronic acid on the density of the mandible in the frontal and lateral sections was studied by multidimensional dispersion analysis. RESULTS: Statistically significant differences (p=0.002) were revealed for density indicators according to CT scans of the mandible in the frontal region against the background of zolendronic acid therapy. We attribute the absence of statistically significant differences for the density of the mandible in the lateral sections (p=0.101 and p=0.082) against the background of zolendronic acid therapy to a measurement bias. We attribute the absence of statistically significant differences in density indices against the background of hormonal, radiation, targeted and chemotherapy to the design of the study. CONCLUSION: Density measurement based on CT examination data can be recommended for use as an additional tool in assessing the effect of zolendronic acid on the density of the mandible. However, the method of measuring the density of the mandible in the lateral sections requires improvement to prevent measurement bias.
Subject(s)
Bone Density Conservation Agents , Bone Density , Mandible , Zoledronic Acid , Humans , Middle Aged , Aged , Zoledronic Acid/therapeutic use , Zoledronic Acid/administration & dosage , Zoledronic Acid/pharmacology , Retrospective Studies , Mandible/diagnostic imaging , Mandible/drug effects , Male , Adult , Female , Aged, 80 and over , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/pharmacology , Bone Density/drug effects , Bone Neoplasms/secondary , Bone Neoplasms/drug therapy , Bone Neoplasms/radiotherapy , Bone Neoplasms/diagnostic imaging , Positron Emission Tomography Computed Tomography , Diphosphonates/administration & dosage , Diphosphonates/therapeutic use , Diphosphonates/pharmacologySubject(s)
Bisphosphonate-Associated Osteonecrosis of the Jaw , Bone Density Conservation Agents , Diphosphonates , Humans , Diphosphonates/therapeutic use , Diphosphonates/administration & dosage , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Mandible/drug effectsABSTRACT
PURPOSE: This systematic review aimed to determine the effects of maternal exposure to bisphosphonates (BPs) during pregnancy on neonatal outcomes. It aimed to disclosfe the impact of BPs on neonates and identify aspects that require further investigation. METHODS: A comprehensive search of PubMed, Science Direct, LILACS, EMBASE, and Web of Science was conducted until August 2022, with no time restrictions. The selection criteria included studies published in English that evaluated pregnant women who were exposed to BPs. RESULTS: From an initial pool of 2169 studies, 13 met the inclusion criteria for this systematic review. These studies collectively included 106 women (108 pregnancies) who were exposed to BPs either before orduring pregnancy. A summary of the key characteristics of the selected studies and the risk of bias assessment are provided. Exposure to BPs occurs at various stages of pregnancy, with different indications for BP treatment. The most frequently reported neonatal outcomes were spontaneous abortion, congenital malformations, hypocalcemia, preterm birth, and low birth weight. CONCLUSION: Although previous reports have linked BPs before or during pregnancy with adverse neonatal outcomes, these associations should be interpreted with caution. Given the complexity of these findings, further research is necessary to provide more definitive insights to guide clinical decisions regarding the use of BPs in pregnant women.
Subject(s)
Bone Density Conservation Agents , Diphosphonates , Pregnancy Outcome , Humans , Pregnancy , Female , Diphosphonates/adverse effects , Diphosphonates/therapeutic use , Diphosphonates/administration & dosage , Infant, Newborn , Bone Density Conservation Agents/adverse effects , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Abortion, Spontaneous/chemically induced , Abortion, Spontaneous/epidemiology , Pregnancy Complications/drug therapy , Premature BirthABSTRACT
Osteoporosis (OP) constitutes a significant health concern that profoundly affects individuals' quality of life. Bisphosphonates, conventional pharmaceuticals widely employed in OP treatment, encounter limitations related to inadequate drug targeting and a short effective duration, thereby compromising their clinical efficacy. The burgeoning field of nanotechnology has witnessed the development and application of diverse functional nanosystems designed for OP treatment. Owing to the bone tissue affinity of bisphosphonates, these nanosystems are modified to address shortcomings associated with traditional drug delivery. In this review, we explore the potential of bisphosphonate-modified nanosystems as a promising strategy for addressing osteoporotic conditions. With functional modification, these nanosystems exhibit a targeted and reversible effect on osteoporotic remodeling, presenting a promising solution to enhance precision in drug delivery. The synthesis methods, physicochemical properties, and in vitro/in vivo performance of bisphosphonate-modified nanosystems are comprehensively examined in this review. Through a thorough analysis of recent advances and accomplishments in this field, we aim to provide insights into the potential applications and future directions of bisphosphonate-modified nanosystems for targeted and reversible osteoporotic remodeling.
Subject(s)
Bone Density Conservation Agents , Diphosphonates , Osteoporosis , Humans , Osteoporosis/drug therapy , Diphosphonates/chemistry , Diphosphonates/administration & dosage , Animals , Bone Density Conservation Agents/administration & dosage , Bone Density Conservation Agents/chemistry , Bone Density Conservation Agents/pharmacology , Drug Delivery Systems , Nanoparticles/chemistrySubject(s)
Bisphosphonate-Associated Osteonecrosis of the Jaw , Bone Density Conservation Agents , Diphosphonates , Humans , Diphosphonates/therapeutic use , Diphosphonates/administration & dosage , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Mandible , Female , MaleABSTRACT
Osteoporosis treatment following arthroplasty for femoral neck fracture (FNF) is associated with lower rates of periprosthetic fracture (PPF). Our study evaluated the economic viability of treatment in patients following arthroplasty and demonstrates that treatment with oral bisphosphonates can be cost-effective in preventing PPF. INTRODUCTION: Osteoporosis treatment following arthroplasty for femoral neck fracture (FNF) is associated with lower rates of periprosthetic fracture (PPF). Although cost-effective in reducing the rate of secondary fragility fracture, the economic viability of osteoporosis treatment in preventing PPF has not been evaluated. Therefore, the purpose of this study is to use a break-even analysis to determine whether and which current osteoporosis medications are cost-effective in preventing PPF following arthroplasty for FNFs. METHODS: Three-year average cost of osteoporosis medication (oral bisphosphonates, estrogen hormonal therapy, intravenous (IV) bisphosphonates, denosumab, teriparatide, and abaloparatide), costs of PPF care, and PPF rates in patients who underwent hip arthroplasty for FNFs without osteoporosis treatment were used to perform a break-even analysis. The absolute risk reduction (ARR) related to osteoporosis treatment and sensitivity analyses were used to evaluate the cost-effectiveness of this intervention and break-even PPF rates. RESULTS: Oral bisphosphonate therapy following arthroplasty for hip fractures would be economically justified if it prevents one out of 56 PPFs (ARR, 1.8%). Given the current cost and incidence of PPF, overall treatment can only be economically viable for PPF prophylaxis if the 3-year costs of these agents are less than $1500. CONCLUSION: The utilization of lower cost osteoporosis medications such as oral bisphosphonates and estrogen hormonal therapy as PPF prophylaxis in this patient population would be economically viable if they reduce the PPF rate by 1.8% and 1.5%, respectively. For IV bisphosphonates and newer agents to be economically viable as PPF prophylaxis in the USA, their costs need to be significantly reduced.
Subject(s)
Arthroplasty, Replacement, Hip , Bone Density Conservation Agents , Cost-Benefit Analysis , Diphosphonates , Drug Costs , Femoral Neck Fractures , Osteoporosis , Periprosthetic Fractures , Humans , Bone Density Conservation Agents/economics , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Femoral Neck Fractures/surgery , Femoral Neck Fractures/economics , Arthroplasty, Replacement, Hip/economics , Arthroplasty, Replacement, Hip/adverse effects , Female , Aged , Periprosthetic Fractures/prevention & control , Periprosthetic Fractures/economics , Drug Costs/statistics & numerical data , Osteoporosis/economics , Osteoporosis/drug therapy , Diphosphonates/economics , Diphosphonates/therapeutic use , Diphosphonates/administration & dosage , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/economics , Osteoporotic Fractures/etiology , Administration, Oral , Male , Health Care Costs/statistics & numerical data , Middle AgedABSTRACT
Background: Bisphosphonates are a class of medication commonly used to treat osteoporosis. Alendronate is recommended as the first-line treatment; however, long-term adherence (both treatment compliance and persistence) is poor. Alternative bisphosphonates are available, which can be given intravenously and have been shown to improve long-term adherence. However, the most clinically effective and cost-effective alternative bisphosphonate regimen remains unclear. What is the most cost-effective bisphosphonate in clinical trials may not be the most cost-effective or acceptable to patients in everyday clinical practice. Objectives: 1. Explore patient, clinician and stakeholder views, experiences and preferences of alendronate compared to alternative bisphosphonates. 2. Update and refine the 2016 systematic review and cost-effectiveness analysis of bisphosphonates, and estimate the value of further research into their benefits. 3. Undertake stakeholder/consensus engagement to identify important research questions and further rank research priorities. Methods: The study was conducted in two stages, stages 1A and 1B in parallel, followed by stage 2: ⢠Stage 1A - we elicited patient and healthcare experiences to understand their preferences of bisphosphonates for the treatment of osteoporosis. This was undertaken by performing a systematic review and framework synthesis of qualitative studies, followed by semistructured qualitative interviews with participants. ⢠Stage 1B - we updated and expanded the existing Health Technology Assessment systematic review and clinical and cost-effectiveness model, incorporating a more comprehensive review of treatment efficacy, safety, side effects, compliance and long-term persistence. ⢠Stage 2 - we identified and ranked further research questions that need to be answered about the effectiveness and acceptability of bisphosphonates. Results: Patients and healthcare professionals identified a number of challenges in adhering to bisphosphonate medication, balancing the potential for long-term risk reduction against the work involved in adhering to oral alendronate. Intravenous zoledronate treatment was generally more acceptable, with such regimens perceived to be more straightforward to engage in, although a portion of patients taking alendronate were satisfied with their current treatment. Intravenous zoledronate was found to be the most effective, with higher adherence rates compared to the other bisphosphonates, for reducing the risk of fragility fracture. However, oral bisphosphonates are more cost-effective than intravenous zoledronate due to the high cost of zoledronate administration in hospital. The importance of including patients and healthcare professionals when setting research priorities is recognised. Important areas for research were related to patient factors influencing treatment selection and effectiveness, how to optimise long-term care and the cost-effectiveness of delivering zoledronate in an alternative, non-hospital setting. Conclusions: Intravenous zoledronate treatment was generally more acceptable to patients and found to be the most effective bisphosphonate and with greater adherence; however, the cost-effectiveness relative to oral alendronate is limited by its higher zoledronate hospital administration costs. Future work: Further research is needed to support people to make decisions influencing treatment selection, effectiveness and optimal long-term care, together with the clinical and cost-effectiveness of intravenous zoledronate administered in a non-hospital (community) setting. Limitations: Lack of clarity and limitations in the many studies included in the systematic review may have under-interpreted some of the findings relating to effects of bisphosphonates. Trial registration: This trial is registered as ISRCTN10491361. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127550) and is published in full in Health Technology Assessment; Vol. 28, No. 21. See the NIHR Funding and Awards website for further award information.
Bisphosphonates are drug treatments commonly used to treat osteoporosis. Alendronate is the most used and is taken by mouth, weekly at a specific time of the week, which can be challenging. Less than one in four people continue this treatment beyond 2 years. Alternative bisphosphonates are available, which vary in frequency and how they are administered. The most acceptable and best value-for-money regimen is unclear. Our aim was to determine how effective alternative bisphosphonates are compared to alendronate at preventing fractures and whether reduction in fracture risk was achieved at a reasonable financial cost, but acceptable to patients. The study was conducted in two stages, stages 1A and 1B in parallel, followed by stage 2: Stage 1A: a review of the published evidence on patients' and doctors' views, experiences and preferences regarding different bisphosphonate treatment regimens, followed by interviews with patients and healthcare professionals. Stage 1B: an update of an existing study on how effective bisphosphonates are in preventing fragility fractures caused by osteoporosis and whether they are good value for money. Stage 2: identification of questions that need to be answered about the effectiveness and acceptability of bisphosphonate treatments. Taking bisphosphonate medication often involves quite a lot of effort by patients, particularly when taking alendronate tablets. A yearly infusion of zoledronate treatment was more acceptable, easier to engage with and the most effective treatment compared to alendronate. However, the cost of administering zoledronate in hospital made alendronate better value for money. Bisphosphonates are effective in reducing the risk of fracture, but 'continuing with treatment', particularly alendronate tablets, remains a challenge. A yearly infusion of zoledronate offers an acceptable and effective treatment, but further research is needed to support patients and healthcare professionals in making decisions about the various treatments, benefits and cost savings of administering zoledronate outside of hospital and in the community.
Subject(s)
Alendronate , Bone Density Conservation Agents , Cost-Benefit Analysis , Diphosphonates , Osteoporotic Fractures , Humans , Diphosphonates/therapeutic use , Diphosphonates/administration & dosage , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Osteoporotic Fractures/prevention & control , Alendronate/therapeutic use , Alendronate/administration & dosage , Alendronate/economics , Female , Osteoporosis/drug therapy , Medication Adherence , Male , Aged , Quality-Adjusted Life Years , Technology Assessment, Biomedical , Middle Aged , Zoledronic Acid/therapeutic use , Zoledronic Acid/administration & dosage , Qualitative ResearchSubject(s)
Bone Density Conservation Agents , Diphosphonates , Scleritis , Humans , Scleritis/drug therapy , Scleritis/chemically induced , Scleritis/diagnosis , Male , Aged , Diphosphonates/adverse effects , Diphosphonates/administration & dosage , Administration, Oral , Bone Density Conservation Agents/adverse effects , Bone Density Conservation Agents/administration & dosage , Injections, Intravenous , Administration, IntravenousABSTRACT
A systematic review was designed to investigate the effect of treatment with oral bisphosphonate (BP) on osseointegration of dental implants and the incidence of BP-related osteonecrosis of the jaw (BRONJ) in postmenopausal women. Multiple electronic databases, including MEDLINE (PubMed), EMBASE, and SCOPUS, were searched to find all eligible articles published since 1990. All titles and abstracts retrieved by searching information sources were evaluated independently by 2 authors against the eligibility criteria. The number of cases ranged from 11 to 235, and the number of controls ranged from 14 to 343. Alendronate was used in all other studies. Risedronate was used in 6 studies, while ibandronate was used in 4 studies. The number of implants in cases ranged from 25 to 1267, while in controls, the number of implants ranged from 28 to 1450. The time between the placement of implant and the follow-up visit ranged from 4-6 months to 8 years. The results show that out of 2582 placed implants, 50 (1.94%) failed in BP-treated patients. This is while out of 4050 placed implants, 188 (4.6%) failed in the non-BP group. The results from the meta-analysis demonstrated that BP therapy is significantly associated with increased implant failure rates (RR = 1.73 [95% CI, 1.03-2.83], P = .04). Overall, the qualitative assessment of this review suggests that oral treatment with BPs in postmenopausal women does not increase the rate of dental implant failure. Thus, further studies with larger sample sizes should compare BP and non-BP groups in regard to dental implants.
Subject(s)
Bisphosphonate-Associated Osteonecrosis of the Jaw , Bone Density Conservation Agents , Dental Implants , Dental Restoration Failure , Diphosphonates , Postmenopause , Humans , Female , Diphosphonates/administration & dosage , Diphosphonates/therapeutic use , Diphosphonates/adverse effects , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Bone Density Conservation Agents/adverse effects , Bisphosphonate-Associated Osteonecrosis of the Jaw/etiology , Bisphosphonate-Associated Osteonecrosis of the Jaw/prevention & control , Osseointegration/drug effects , Administration, OralABSTRACT
PURPOSE: We evaluated the preference, patient satisfaction, and efficacy of zoledronic acid compared with oral bisphosphonates (BPs) for glucocorticoid-induced osteoporosis (GIOP) in patients with autoimmune diseases. METHODS: We enrolled 50 patients with new fractures or osteoporosis detected on follow-up bone densitometry after at least 1 year of oral BP use among patients diagnosed with GIOP during treatment for autoimmune diseases. After 1 year of zoledronic acid treatment, patients completed a survey for preference and satisfaction assessment. Treatment efficacy was analysed by comparing bone mineral density changes and fractures with those in a control group of patients who continued oral BP use. RESULTS: Age, sex, treatment duration, and medication history did not differ significantly between the two groups. Among the participants, 86.7% preferred and were more satisfied with intravenous zoledronic acid than with oral BPs, primarily because of the convenience of its administration interval. Only two patients (4%) reported infusion-related adverse events with zoledronic acid. Furthermore, no significant differences were observed in the annualized percentage change in the bone mineral density of the lumbar spine, femur neck, and hip between patients receiving zoledronic acid and those receiving oral BPs. The occurrence of new fractures was consistent across both groups, with two cases in each, showing no significant differences. CONCLUSION: Patients showed a preference for and greater satisfaction with zoledronic acid, and its efficacy in treating osteoporosis was comparable to that of oral BPs. Therefore, zoledronic acid is a suitable treatment option for GIOP in patients with autoimmune diseases.
Subject(s)
Autoimmune Diseases , Bone Density Conservation Agents , Bone Density , Glucocorticoids , Osteoporosis , Patient Preference , Zoledronic Acid , Humans , Zoledronic Acid/therapeutic use , Zoledronic Acid/adverse effects , Osteoporosis/drug therapy , Osteoporosis/chemically induced , Female , Glucocorticoids/adverse effects , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use , Male , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/adverse effects , Autoimmune Diseases/drug therapy , Autoimmune Diseases/chemically induced , Middle Aged , Bone Density/drug effects , Aged , Administration, Oral , Diphosphonates/therapeutic use , Diphosphonates/adverse effects , Diphosphonates/administration & dosage , Patient Satisfaction , Treatment Outcome , Imidazoles/adverse effects , Imidazoles/therapeutic use , Imidazoles/administration & dosageABSTRACT
PURPOSE: The aim of this study was to evaluate changes in hip geometry parameters following treatment with teriparatide (TPD), denosumab (Dmab) and zoledronate (ZOL) in real-life setting. METHODS: We studied 249 patients with osteoporosis (OP) with mean [SD] age of 71.5 [11.1] years divided into 3 treatment groups; Group A received TPD; n = 55, Group B (Dmab); n = 116 and Group C (ZOL); n = 78 attending a routine metabolic bone clinic. Bone mineral density (BMD) was measured by DXA at the lumbar spine (LS), total hip (TH) and femoral neck (FN) prior to treatment and after 2 years (Group A), after a mean treatment duration of 3.3 [1.3] years (Group B) and after 1, 2 and 3 doses of ZOL (Group C) to assess treatment response. Hip structural analysis (HSA) was carried out retrospectively from DXA-acquired femur images at the narrow neck (NN), the intertrochanter (IT) and femoral shaft (FS). RESULTS: Changes in parameters of hip geometry and mechanical strength were seen in the following treatment. Percentage change in cross-sectional area (CSA): 3.56[1.6] % p = 0.01 and cross-sectional moment of inertia (CSMI): 4.1[1.8] % p = 0.029 increased at the NN only in Group A. Improvement in HSA parameters at the IT were seen in group B: CSA: 3.3[0.67]% p < 0.001, cortical thickness (Co Th): 2.8[0.78]% p = 0.001, CSMI: 5.9[1.3]% p < 0.001, section modulus (Z):6.2[1.1]% p < 0.001 and buckling ratio (BR): - 3.0[0.86]% p = 0.001 with small changes at the FS: CSA: 1.2[0.4]% p = 0.005, Z:1.6 [0.76]%, p = 0.04. Changes at the IT were also seen in Group C (after 2 doses): CSA: 2.5[0.77]% p = 0.017, Co Th: 2.4[0.84]% p = 0.012, CSMI: 3.9[1.3]% p = 0.017, Z:5.2[1.16]% p < 0.001 and BR: - 3.1[0.88]% p = 0.001 and at the NN (following 3 doses): outer diameter (OD): 4.0[1.4]% p = 0.0005, endocortical diameter(ED): 4.3[1.67% p = 0.009, CSA:5.2[1.8]% p = 0.003, CSMI: 9.3[3.8]% p = 0.019. CONCLUSIONS: Analysis of the effect of OP therapies on hip geometry is useful in understanding the mechanisms of their anti-fracture effect and may provide additional information on their efficacy.
Subject(s)
Bone Density Conservation Agents , Bone Density , Denosumab , Osteoporosis , Teriparatide , Zoledronic Acid , Humans , Female , Zoledronic Acid/therapeutic use , Zoledronic Acid/administration & dosage , Zoledronic Acid/pharmacology , Teriparatide/therapeutic use , Teriparatide/administration & dosage , Teriparatide/pharmacology , Aged , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Bone Density/drug effects , Male , Denosumab/therapeutic use , Denosumab/administration & dosage , Osteoporosis/drug therapy , Osteoporosis/pathology , Retrospective Studies , Absorptiometry, Photon , Diphosphonates/therapeutic use , Diphosphonates/administration & dosage , Middle Aged , Aged, 80 and over , Follow-Up StudiesABSTRACT
BACKGROUND: Ibandronate is effective in reducing the risk of vertebral fractures, but experimental evidence offers conflicting results regarding nonvertebral fractures. Real-world evidence has been published evaluating the anti-nonvertebral fracture effect of ibandronate. AIM: This meta-analysis of observational studies assessed the effectiveness of ibandronate in reducing the risk of nonvertebral fractures in women with osteoporosis. METHOD: Pubmed/Embase databases were searched for observational studies. Risks of nonvertebral fractures and hip fractures were the outcomes. Meta-analyses were performed pooling rate ratios (RRs), using random-effects models. Data were reanalysed in sensitivity analyses considering Knapp-Hartung method and Bayesian random-effects. RESULTS: Six cohort studies were included. Overall, once-monthly 150 mg oral ibandronate reduced the risk of nonvertebral fractures (RR 0.84; 95% CI 0.76-0.94). Similar results were obtained when the comparison was restricted to once-monthly 150 mg risedronate, but no differences were found when the comparator was other oral bisphosphonates (weekly alendronate/risedronate). Ibandronate didn't significantly change the risk of hip fractures (RR 1.25; 95% CI 0.89-1.76). The risk of hip fracture was comparable between once monthly, 150 mg oral ibandronate and other oral bisphosphonates. Intravenous ibandronate was not effective in reducing hip fractures comparing to intravenous zoledronate. The low number of studies diminished the robustness of sensitivity analyses. CONCLUSION: Results suggest that once-monthly 150 mg oral ibandronate may be as effective as other oral bisphosphonates in reducing the risk of nonvertebral fractures. However, uncertainty associated to the small number of included studies, which are characterized by heterogeneous demographics and methodologies, precluded definitive conclusions.
Subject(s)
Bone Density Conservation Agents , Diphosphonates , Ibandronic Acid , Observational Studies as Topic , Humans , Ibandronic Acid/therapeutic use , Ibandronic Acid/administration & dosage , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Female , Diphosphonates/administration & dosage , Diphosphonates/therapeutic use , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/epidemiology , Osteoporosis/drug therapy , Osteoporosis, Postmenopausal/drug therapy , Osteoporosis, Postmenopausal/complicationsSubject(s)
Humans , Female , Middle Aged , Aged , Bone Density Conservation Agents/administration & dosage , Bone Density Conservation Agents/adverse effects , Diphosphonates/administration & dosage , Diphosphonates/adverse effects , Eye Diseases/chemically induced , Infusions, Parenteral/adverse effectsABSTRACT
El síndrome de dolor regional complejo (SDRC) es una patología poco frecuente, caracterizada por dolor crónico y cambios locales del sitio afectado. Ocurre en forma posterior a un traumatismo, o, menos frecuentemente, sin desencadenante claro. El diagnóstico se realiza de forma clínica, evaluando la presencia de hallazgos típicos detallados en los criterios de Budapest, como el dolor continuo y desproporcionado, y síntomas y signos típicos, como edema, asimetría térmica y disminución del rango de movilidad. Los estudios por imágenes, así como la radiografía, la resonancia magnética o el centellograma óseo de 3 fases, también brindan información valiosa, sobre todo en los casos que se presentan con más dudas, y para realizar diagnóstico diferencial de otras patologías. En este sentido, la medición de la densidad mineral ósea por absorciometría dual de rayos X (DXA) se presenta también como herramienta de utilidad, no solo en la fase diagnóstica, al evidenciar la mayor desmineralización del miembro afectado, sino también en la evaluación de la respuesta terapéutica a bifosfonatos. Presentamos el caso de una paciente con SDRC del miembro inferior, donde la densitometría ósea resultó de gran utilidad en su manejo clínico. (AU)
Complex regional pain syndrome (CRPS) is a rare pathology, characterized by chronic pain and local changes of the affected site. It occurs after trauma or, less frequently, without a clear trigger. The diagnosis is made clinically, evaluating the presence of typical findings detailed in the Budapest criteria, such as continuous and disproportionate pain, and typical signs and symptoms, like edema, thermal asymmetry, and decreased range of motion. Imaging studies, such as radiography, magnetic resonance imaging, or 3-phase bone scintigraphy also provide valuable information, especially in cases that present with more doubts, and to make a differential diagnosis with other pathologies. In this regard, the measurement of bone mineral density by dual X-ray absorptiometry (DXA) is also a useful tool, not only in the diagnostic phase, by showing the greater demineralization of the affected limb, but also in the evaluation of the therapeutic response to bisphosphonates. We present the case of a patient with CRPS of the lower limb, where bone densitometry was very useful in her clinical management. (AU)
Subject(s)
Humans , Female , Middle Aged , Complex Regional Pain Syndromes/diagnosis , Complex Regional Pain Syndromes/pathology , Complex Regional Pain Syndromes/drug therapy , Densitometry , Bone Density , Complex Regional Pain Syndromes/diagnostic imaging , Diagnosis, Differential , Diphosphonates/administration & dosage , Chronic Pain/etiologyABSTRACT
La amiloidosis cardíaca relacionada con el depósito de transtirretina (ATTR) ha sido tradicionalmente considerada como una enfermedad rara, de difícil diagnóstico y sin tratamiento. Sin embargo, en la actualidad sabemos que su prevalencia es mayor de la considerada, disponemos de métodos diagnósticos no invasivos y están apareciendo tratamientos eficaces. En este contexto, la gammagrafía cardíaca (GC) con difosfonatos marcados con 99mTc ha alcanzado un inusitado interés al mostrar alta sensibilidad y especificidad para el diagnóstico no invasivo y fiable de la ATTR. Este artículo, a modo de guía, pretende identificar los componentes críticos en la realización de la GC que resulten de utilidad en la práctica clínica diaria y, así, ayudar a los especialistas a utilizar los radiofármacos idóneos, obtener las imágenes más adecuadas, interpretar los resultados de estas y conocer los escenarios clínicos en los que resulta apropiado realizar la GC
Transthyretin cardiac amyloidosis (ATTR) has traditionally been considered a rare, difficult-to-diagnose and untreatable disease. However, its prevalence is known to be greater than what was previously thought, non-invasive diagnostic methods are available, and that effective treatments are emerging. In this context, cardiac scintigraphy (CS) with 99mTc-labelled diphosphonates has aroused a noticeable surge in interest by demonstrating high sensitivity and specificity for the reliable, non-invasive diagnosis of ATTR. By way of a guide, this article aims to identify the critical components in the performance of CS that are useful in everyday clinical practice and, thus, help specialists use optimal radiopharmaceuticals, obtain the most appropriate images, interpret the results thereof, and acquaint themselves with those clinical scenarios in which it is convenient to perform CS