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1.
PLoS One ; 19(7): e0307029, 2024.
Article in English | MEDLINE | ID: mdl-39024281

ABSTRACT

OBJECTIVE: To analyze osteoporosis medication prescribing trends across specialties in the context of a Bone Health Clinic. INTRODUCTION: Osteoporosis affects over 10 million adults in the US, taking a significant toll on patients and the healthcare system. Although screening methods and treatments are improving, the disease remains underdiagnosed and undertreated. This study aims to evaluate the prescribing trends of osteoporosis medication among department specialties to delineate the benefits of a bone health clinic. METHODS: Retrospective data collection identified and analyzed patients within the Penn State Health system prescribed one of the following osteoporosis medications: Bisphosphonate, denosumab, romosozumab, teriparatide, abaloparatide, or raloxifene. Date range: 4/18/2016 to 4/14/2021. Data collection identified the specialty origin of prescriptions for osteoporosis medications across various medical specialties (e.g., orthopaedics, family medicine, and internal medicine). RESULTS: 10,736 prescription orders were issued to patients with an average age of 68 years. Non-Hispanic Caucasian patients received 88.6% of prescriptions, followed by Asian (3.4%) and African American (2.2%). Female patients accounted for 87.8% of all prescriptions. The Bone Health Clinic under two orthopaedic providers wrote 3,619 prescriptions, averaging 361.9 prescriptions per provider per year-marking the highest rate among specialties. The clinic prescriptions constituted 33.7% of all prescriptions across specialties. Orthopaedic surgery prescribed the most denosumab, romosozumab, teriparatide, and abaloparatide prescriptions, and had the highest number of male osteoporosis patients compared to other specialties (15.6%), consequently prescribing the most male prescriptions (578). CONCLUSION: Establishing a bone health clinic dedicated to osteoporosis management leads to significantly higher prescription rates per provider, increased utilization of anabolic therapies compared to other specialties, and more male patients being treated-an often-neglected population in osteoporosis.


Subject(s)
Bone Density Conservation Agents , Osteoporosis , Practice Patterns, Physicians' , Humans , Osteoporosis/drug therapy , Female , Male , Aged , Retrospective Studies , Bone Density Conservation Agents/therapeutic use , Middle Aged , Practice Patterns, Physicians'/statistics & numerical data , Drug Prescriptions/statistics & numerical data , Aged, 80 and over , Denosumab/therapeutic use , Teriparatide/therapeutic use , Diphosphonates/therapeutic use
2.
Int J Oral Maxillofac Implants ; (3): 435-445, 2024 Jun 21.
Article in English | MEDLINE | ID: mdl-38905118

ABSTRACT

PURPOSE: To evaluate the efficacy of combined therapy of teriparatide and raloxifene on the osseointegration of titanium dental implants in a rabbit model of osteoporotic bone. MATERIALS AND METHODS: Sixty female rabbits were randomly divided into six groups. The sham ovariectomy group (control) consisted of animals that received no medication. Animals in the ovariectomy group (OVX) underwent ovariectomy and received no medication. The combined group consisted of ovariectomized animals that received combined teriparatide (10 mg/kg) for 12 weeks and raloxifene (10 mg/kg) for 12 weeks. The sequential group (SEQ) consisted of ovariectomized animals that received teriparatide (10 mg/kg) for the first 6 weeks and raloxifene therapy (10 mg/kg) for the following 6 weeks sequentially. The parathormone (PTH) and raloxifene (RAL) groups consisted of ovariectomized animals that received only teriparatide (10 mg/kg) for 12 weeks or raloxifene (10 mg/kg) for 12 weeks, respectively. Dental implants (Bilimplant) were placed in the proximal metaphysis of both tibias in all rabbits. Histomorphometric and microCT studies were performed on the specimens obtained from the right tibia bone. Removal torque (RTQ) and implant stability quotient (ISQ) tests were performed on the specimens obtained from the left tibia bone. The results were compared and evaluated statistically. RESULTS: RTQ analysis revealed a statistically significant difference between the mean values of the combined group (93.01 ± 27.19 Ncm) and the OVX group (49.6 ± 12.5 Ncm) (P = .015). The highest mean T0 (implantation day) value was obtained in the control group (67.1 ± 3.4 Ncm), and the lowest mean value was obtained in the OVX group (61.4 ± 3.8 Ncm). The highest T1 mean (3 months after implantation) was obtained by the combined group (76.6 ± 3.8 Ncm), and the lowest mean was obtained by the OVX group (68.9 ± 6.2 Ncm). Histomorphometric analyses showed that the mean percentage of bone-to-implant contact (BIC%) of the combined group (51.2%) was significantly higher than that of the OVX group (28.6%) (P =.006). In the microCT examinations, it was found that the mean BIC% value of the combined group (41.1%) was significantly higher than that of the OVX group (24.1%) (P < .001). CONCLUSIONS: According to the results of the current study, combined therapy of teriparatide and raloxifene improves the BIC and osseointegration of titanium dental implants in osteoporotic bone compared with sequential or independent therapy with these agents.


Subject(s)
Bone Density Conservation Agents , Dental Implants , Disease Models, Animal , Osseointegration , Osteoporosis , Ovariectomy , Raloxifene Hydrochloride , Teriparatide , Animals , Rabbits , Teriparatide/therapeutic use , Teriparatide/pharmacology , Raloxifene Hydrochloride/pharmacology , Raloxifene Hydrochloride/therapeutic use , Osseointegration/drug effects , Female , Bone Density Conservation Agents/pharmacology , Bone Density Conservation Agents/therapeutic use , Osteoporosis/drug therapy , Dental Implantation, Endosseous/methods , X-Ray Microtomography , Random Allocation , Titanium , Drug Therapy, Combination
3.
Reumatismo ; 76(2)2024 Jun 24.
Article in English | MEDLINE | ID: mdl-38916162

ABSTRACT

OBJECTIVE: Fragility fractures (FF) resulting from osteoporosis pose a significant public health challenge in Italy, with considerable socio-health and economic implications. Despite the availability of safe and effective drugs, osteoporosis remains underdiagnosed and undertreated, leaving over 2 million high-risk Italian women without treatment. This paper aims to identify and propose key improvements in the management of osteoporosis, focusing particularly on the critical issues related to the use of anabolic drugs in secondary prevention, according to the current Italian Medicines Agency (AIFA) Note 79. METHODS: The Expert Panel, composed of nine recognized Italian experts in rheumatology, analyzed current practices, prescribing criteria, and the most recent literature. Three main reasons for revising the indications on pharmacological treatment of osteoporosis were identified: inadequate treatment of osteoporosis, new evidence regarding frontline placement of anabolics in high-risk conditions, and emerging sequential or combined strategies. RESULTS: The proposed improvements include the adoption of the Derived Fracture Risk Assessment algorithm for accurate fracture risk assessment, revision of AIFA Note 79 to reflect current evidence, improved prescribing appropriateness, broader access to anabolic agents, and the provision of sequential therapies with antiresorptives for teriparatide. These changes aim to enhance patient outcomes, streamline healthcare processes, and address the high percentage of undertreated individuals. CONCLUSIONS: This expert opinion emphasizes the importance of the appropriate use of anabolic drugs to reduce FF and associated costs while ensuring the sustainability of the National Health Service. The proposed recommendations are in line with the latest scientific evidence, providing a comprehensive strategy to optimize the management of osteoporosis in Italy. On behalf of the Study Group on Osteoporosis and Skeletal Metabolic Diseases of the Italian Society of Rheumatology.


Subject(s)
Anabolic Agents , Bone Density Conservation Agents , Osteoporosis , Osteoporotic Fractures , Humans , Italy , Anabolic Agents/therapeutic use , Osteoporosis/drug therapy , Bone Density Conservation Agents/therapeutic use , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/etiology , Osteoporotic Fractures/epidemiology , Female , Teriparatide/therapeutic use , Risk Assessment , Secondary Prevention , Expert Testimony
4.
Eur J Endocrinol ; 191(1): R9-R21, 2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38938063

ABSTRACT

Osteoanabolic agents are used as a first line treatment in patients at high fracture risk. The PTH receptor 1 (PTH1R) agonists teriparatide (TPTD) and abaloparatide (ABL) increase bone formation, bone mineral density (BMD), and bone strength by activating PTH receptors on osteoblasts. Romosozumab (ROMO), a humanized monoclonal antibody against sclerostin, dramatically but transiently stimulates bone formation and persistently reduces bone resorption. Osteoanabolic agents increase BMD and bone strength while being more effective than antiresorptives in reducing fracture risk in postmenopausal women. However, direct comparisons of the antifracture benefits of osteoanabolic therapies are limited. In a direct comparison of TPTD and ABL, the latter resulted in greater BMD increases at the hip. While no differences in vertebral or non-vertebral fracture risk were observed between the two drugs, ABL led to a greater reduction of major osteoporotic fractures. Adverse event profiles were similar between the two agents except for hypercalcemia, which occurred more often with TPTD. No direct comparisons of fracture risk reduction between ROMO and the PTH1R agonists exist. Individual studies have shown greater increases in BMD and bone strength with ROMO compared with TPTD in treatment-naive women and in women previously treated with bisphosphonates. Some safety aspects, such as a history of tumor precluding the use of PTH1R agonists, and a history of major cardiovascular events precluding the use of ROMO, should also be considered when choosing between these agents. Finally, convenience of administration, reimbursement by national health systems and length of clinical experience may influence patient choice.


Subject(s)
Antibodies, Monoclonal , Bone Density Conservation Agents , Bone Density , Receptor, Parathyroid Hormone, Type 1 , Teriparatide , Humans , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal/adverse effects , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/pharmacology , Bone Density/drug effects , Teriparatide/therapeutic use , Receptor, Parathyroid Hormone, Type 1/agonists , Female , Osteoporotic Fractures/prevention & control , Parathyroid Hormone-Related Protein/therapeutic use , Osteoporosis, Postmenopausal/drug therapy
5.
Calcif Tissue Int ; 115(2): 169-173, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38907093

ABSTRACT

Teriparatide is an anabolic drug sometimes administered to patients who have atypical femoral fracture (AFF). However, whether teriparatide has beneficial effects on bone healing remains uncertain. The present study aimed to analyze the association between teriparatide and bone healing in complete AFF. A total of 59 consecutive cases (58 patients) who underwent intramedullary nailing for complete AFF were categorized based on postoperative use of teriparatide into the non-teriparatide (non-TPTD, n = 34) and teriparatide groups (TPTD, n = 25). Time-to-bone union was evaluated and compared between the two groups. Additionally, multiple regression analysis was performed to evaluate factors affecting time-to-bone union. All participants were women, with a mean age of 77.6 years (range: 62-92). No significant difference in time-to-bone union was found between the non-TPTD and TPTD groups (5.5 months vs. 5.8 months, p = 0.359). Two patients in the non-TPTD group underwent reoperation (p = 0.503) due to failure caused by inadequate fixation, and both achieved bone healing after additional fixation with blocking screws. Multiple regression analysis revealed that the anterior gap of the fracture site postoperatively was a factor affecting time-to-bone union (p = 0.014). The beneficial effect of teriparatide on bone healing in complete AFF could not be confirmed. Additional randomized controlled trials are required. Nonetheless, appropriate techniques, including efforts to reduce the gap on the tensile side during the surgery, are important for reliable bone healing.


Subject(s)
Bone Density Conservation Agents , Femoral Fractures , Fracture Healing , Teriparatide , Humans , Teriparatide/therapeutic use , Teriparatide/pharmacology , Female , Femoral Fractures/drug therapy , Aged , Fracture Healing/drug effects , Aged, 80 and over , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/pharmacology , Middle Aged , Fracture Fixation, Intramedullary/methods , Treatment Outcome , Retrospective Studies
6.
Medicina (Kaunas) ; 60(6)2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38929563

ABSTRACT

Background: Teriparatide is an anabolic agent for osteoporosis and is believed to improve the bone healing process. Previous studies showed that teriparatide could enhance not only fracture healing but also spine fusion. It has been reported that use of teriparatide could promote the spine fusion process and decrease mechanical complications. However, there was no consensus regarding optimal treatment duration. The purpose of this study was to compare surgical outcomes between short-duration and long-duration teriparatide treatment after lumbar fusion surgery in elderly patients. Materials and Methods: All consecutive patients older than 60 years who underwent 1-level lumbar fusion surgery for degenerative diseases between January 2015 and December 2019 were retrospectively reviewed. Based on the duration of teriparatide treatment (daily subcutaneous injection of 20 µg teriparatide), patients were subdivided into two groups: a short-duration (SD) group (<6 months) and a long-duration (LD) group (≥6 months). Mechanical complications, such as screw loosening, cage subsidence, and adjacent vertebral fractures, were investigated. Postoperative 1-year union rate was also evaluated on computed tomography. Clinical outcomes were recorded using visual analog scale (VAS) and Oswestry Disability Index (ODI). Between-group differences for these radiographic and clinical outcomes were analyzed. Results: Ninety-one patients were reviewed in this study, including sixty patients in the SD group and thirty-one patients in the LD group. Their mean age was 72.3 ± 6.2 years, and 79 patients were female. Mean T-score was -3.3 ± 0.8. Cage subsidence (6.7% vs. 3.2%), screw loosening (28.3% vs. 35.5%), and adjacent vertebral fracture (6.7% vs. 9.7%) were not significantly different between the SD and LD groups. Union rate at 1-year postoperative was 65.0% in the SD group and 87.1% in the LD group (p = 0.028). Both groups showed improvement in VAS and ODI after surgery. However, the differences of VAS from preoperative to 6 months and 1 year postoperative were significantly higher in the LD group. Conclusions: Longer teriparatide treatment after lumbar fusion surgery resulted in a higher union rate at 1-year postoperative than the shorter treatment. Also, it could be more beneficial for clinical outcomes.


Subject(s)
Spinal Fusion , Teriparatide , Humans , Teriparatide/therapeutic use , Teriparatide/administration & dosage , Female , Male , Spinal Fusion/methods , Aged , Retrospective Studies , Treatment Outcome , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/administration & dosage , Lumbar Vertebrae/surgery , Aged, 80 and over , Time Factors , Middle Aged
7.
Eur Spine J ; 33(8): 3284-3290, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38937348

ABSTRACT

PURPOSE: To investigate efficacy of 3-month teriparatide(TPD) and compare this treatment with vertebroplasty in terms of clinical and radiographic outcomes after osteoporotic vertebral compression fractures (OVCFs). METHODS: This is a retrospective matched cohort study. Patients who received conservative treatment with at least 3-month TPD treatment for acute OVCF with at least 6 months follow-up were included. Each enrolled TPD case was matched with 2 vertebroplasty cases using age and gender. 30 TPD cases and 60 vertebroplasty cases were enrolled. Patient-reported pain scores were obtained at diagnosis and 1, 3, 6 months after diagnosis. Radiographic parameters including middle body height, posterior body height, wedge angle and kyphotic angle were measured at diagnosis and 6 months after diagnosis. Fracture non-union and subsequent vertebral fracture were evaluated. RESULTS: TPD treatment showed inferior pain relief to vertebroplasty group at 1 month, but did not show difference at 3 and 6 months after diagnosis. In TPD cases, progression of vertebral body collapse was noted in terms of middle body height and wedge angle at final follow up. Instead, both middle body height and wedge angle increased significantly after operation in the vertebroplasty group. Fracture non-union was confirmed via MRI and 4 TPD patients were diagnosed with non-union (4/30, 13.3%). Subsequent compression fracture within 6 months was significant higher in vertebroplasty group (12/60, 20%) than in TPD group (1/30, 3.3%). CONCLUSION: In acute OVCFs, 3-month TPD treatment alone showed comparable pain improvement and less subsequent spine fracture than vertebroplasty.


Subject(s)
Fractures, Compression , Osteoporotic Fractures , Spinal Fractures , Teriparatide , Vertebroplasty , Humans , Fractures, Compression/surgery , Fractures, Compression/diagnostic imaging , Vertebroplasty/methods , Female , Spinal Fractures/surgery , Spinal Fractures/diagnostic imaging , Aged , Male , Osteoporotic Fractures/surgery , Osteoporotic Fractures/diagnostic imaging , Retrospective Studies , Teriparatide/therapeutic use , Aged, 80 and over , Treatment Outcome , Bone Density Conservation Agents/therapeutic use , Middle Aged , Pain Management/methods
8.
Curr Opin Endocrinol Diabetes Obes ; 31(4): 157-163, 2024 Aug 01.
Article in English | MEDLINE | ID: mdl-38752851

ABSTRACT

PURPOSE OF REVIEW: Anabolic therapies have revolutionized the management of patients with osteoporosis, especially those at very high fracture risk. The current review offers valuable insights into the latest evidence and guidelines on the use of anabolic agents, focusing on their comparative efficacy, safety profiles, and optimal implementation in clinical practice. RECENT FINDINGS: Romosozumab, abaloparatide, and teriparatide have shown superior efficacy when compared to antiresorptive therapies in increasing bone mineral density and reducing fracture risk. Notably, sequential treatment strategies, commencing with an anabolic agent followed by an antiresorptive, has emerged as an effective approach for both rapid and sustained reduction of fracture risk in patients at high risk. Additionally, anabolics have shown potential in improving outcomes for patients who have a suboptimal response to antiresorptives. Careful patient selection and vigilant monitoring are essential to optimize therapeutic benefits while mitigating the potential risks. As we gain more clinical experience with these agents, we will better understand how to use them effectively, as part of long term, sequential treatment strategies. Ongoing research into novel anabolic therapies and innovative treatment sequences holds promise for expanding our toolkit against fragility fractures. SUMMARY: Integrating anabolic agents into personalized treatment plans has the potential to significantly improve outcomes and quality of life for patients with severe osteoporosis, highlighting the importance of this therapeutic class in the management of this chronic condition.


Subject(s)
Anabolic Agents , Bone Density Conservation Agents , Bone Density , Osteoporosis , Osteoporotic Fractures , Humans , Anabolic Agents/therapeutic use , Osteoporosis/drug therapy , Bone Density Conservation Agents/therapeutic use , Osteoporotic Fractures/prevention & control , Bone Density/drug effects , Teriparatide/therapeutic use , Antibodies, Monoclonal , Parathyroid Hormone-Related Protein
9.
J Bone Miner Metab ; 42(3): 382-388, 2024 May.
Article in English | MEDLINE | ID: mdl-38755328

ABSTRACT

INTRODUCTION: The purpose of this study was to evaluate whether bone mineral density (BMD) ≥ -2.5 SD could be used as the treat-to-target (T2T) goal when treating osteoporosis with teriparatide (TPTD) and alendronate (ALN), and to investigate the relationship with incident vertebral fracture by re-analyzing data from a randomized, controlled trial (JOINT-05) involving postmenopausal Japanese women at high fracture risk. MATERIALS AND METHODS: Participants received sequential therapy with once-weekly TPTD for 72 weeks, followed by ALN for 48 weeks (TPTD-ALN group) or ALN monotherapy for 120 weeks (ALN group). BMDs were measured at the lumbar spine (L2-4), total hip, and femoral neck at 0, 24, 48, 72, and 120 weeks by dual-energy X-ray absorptiometry. The T2T goal was BMD ≥ -2.5 SD, and the endpoint was the proportion of participants with baseline BMD < -2.5 SD in three measurement sites achieving BMD ≥ -2.5 SD. RESULTS: A total of 559 participants were selected. BMD ≥ -2.5 SD at 120 weeks in the L2-4, total hip, and femoral neck sites was achieved in 20.5%, 23.1%, and 5.9%, respectively, in the TPTD-ALN group and 22.2%, 11.7%, and 7.3%, respectively, in the ALN group. Incident vertebral fractures occurred in areas of both lower and high BMD. CONCLUSION: During the 1.5-year treatment period, more than 20% of participants achieved BMD ≥ -2.5 SD as a T2T goal at L2-4. Since the achievement level differed depending on the BMD measurement site, the appropriate site should be selected according to the baseline BMD level.


Subject(s)
Alendronate , Bone Density , Teriparatide , Humans , Alendronate/therapeutic use , Female , Teriparatide/therapeutic use , Bone Density/drug effects , Aged , Middle Aged , Bone Density Conservation Agents/therapeutic use , Japan , Osteoporosis/drug therapy , Osteoporosis, Postmenopausal/drug therapy , Spinal Fractures/prevention & control , Spinal Fractures/epidemiology , Lumbar Vertebrae/drug effects , East Asian People
10.
J Pak Med Assoc ; 74(4): 741-751, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38751272

ABSTRACT

Objective: To evaluate the effect of subcutaneous teriparatide therapy on fracture healing rate and change in bone mass density in osteoporotic hip fractures. METHODS: The meta-analysis was done from September to December 2022, and comprised literature search on Wanfang, CNKI, VIP, PubMed, Embase, Cochrane Library, and Web of Science databases from the establishment of the respective database till December 2022. The relevant journals of the library of Macao University of Science and Technology, China, were manually searched for randomised controlled trials of teriparatide in the treatment of osteoporotic hip fractures. The shortlisted studies were subjectd to Cochrane Risk of Bias tool and the Jadad Rating Scale. Meta-analysis was done using the RevMan 5.4 software provided by the Cochrane Collaboration Network. Fracture healing rate and bone mineral density were the primary outcome measures, while mortality, adverse events, malformations, complications, subsequent fractures, timed-up-and-go test, visual analogue scale score, and procollagen type I N-terminal propeptide were the secondary outcome measures. RESULTS: Of the 1,094 articles retrieved, 8(0.7%) randomised controlled trials were analysed. There were 744 patients; 372(50%) in the teriparatide group and 372(50%) in the control group. Fracture healing rate was not significantly different (p=0.82), while bone mineral density was significantly different between the groups (p<0.001). Mortality, adverse events, deformity, and complications were not significantly different (p>0.05), while subsequent fractures, timed-up-and-go score, visual analogue scale score and procollagen type I N-terminal propeptide were significantly different between the groups (p<0.05). Conclusion: The literature did not support teriparatide's ability to improve the healing rate of osteoporotic hip fractures, or to reduce mortality, adverse events, malformations, and complications. In addition, teriparatide could increase bone mineral density of osteoporotic hip fractures and the procollagen type I N-terminal propeptide value, alleviate hip pain, and reduce subsequent fracture rates. This trial is registered with PROSPERO with registration number CRD42022379832.


Subject(s)
Bone Density Conservation Agents , Bone Density , Fracture Healing , Hip Fractures , Osteoporotic Fractures , Teriparatide , Humans , Teriparatide/therapeutic use , Osteoporotic Fractures/prevention & control , Bone Density Conservation Agents/therapeutic use , Bone Density/drug effects , Fracture Healing/drug effects , Bone Remodeling/drug effects , Randomized Controlled Trials as Topic , Peptide Fragments , Procollagen/blood
11.
Zhonghua Yi Xue Za Zhi ; 104(17): 1456-1465, 2024 May 07.
Article in Chinese | MEDLINE | ID: mdl-38706051

ABSTRACT

Osteoporotic fracture is the most serious complication of osteoporosis, which is a special type of pathologic fracture of the skeleton that occurs because of osteoporosis. It is characterized by delayed fracture healing, high risk of re-fracture, high rate of disability and death, difficulty in treatment and long treatment time, and re-fracture has a"cascade effect". Guidelines in different countries recommend that patients with osteoporotic fractures and those at very high risk of fracture should consider anabolic agents as first treatment choice. Teriparatide is the only anabolic agent approved by National Medical Products Administration (NMPA), and it has the clinical efficacy of improving fracture healing, reducing the risk of re-fracture, and improving bone microstructure in the treatment of osteoporotic fracture. Due to deficiencies in the current standardization of clinical use of teriparatide, Committee of Accelerated Rehabilitation After Osteoporotic Fractures of China Association of Rehabilitation Technology Transformation and Promotion, Bone and Joint Group of Chinese Society of Osteoporosis and Bone Mineral Research and Osteoporosis Working Committee of Chinese Association of Orthopedic Surgeons developed this consensus. The development of this consensus follows the modified Delphi method and forms 8 evidence-based medical recommendations, aiming to propose methods and precautions for standardizing the application of teriparatide, and to emphasize the importance of teriparatide application for the treatment of patients with osteoporotic fracture.


Subject(s)
Bone Density Conservation Agents , Osteoporosis , Osteoporotic Fractures , Teriparatide , Teriparatide/therapeutic use , Humans , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/drug therapy , Bone Density Conservation Agents/therapeutic use , Osteoporosis/drug therapy , China , Consensus
13.
Osteoporos Int ; 35(8): 1337-1358, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38587674

ABSTRACT

Antiresorptive medications do not negatively affect fracture healing in humans. Teriparatide may decrease time to fracture healing. Romosozumab has not shown a beneficial effect on human fracture healing. BACKGROUND: Fracture healing is a complex process. Uncertainty exists over the influence of osteoporosis and the medications used to treat it on fracture healing. METHODS: Narrative review authored by the members of the Fracture Working Group of the Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF), on behalf of the IOF and the Société Internationale de Chirurgie Orthopédique et de Traumatologie (SICOT). RESULTS: Fracture healing is a multistep process. Most fractures heal through a combination of intramembranous and endochondral ossification. Radiographic imaging is important for evaluating fracture healing and for detecting delayed or non-union. The presence of callus formation, bridging trabeculae, and a decrease in the size of the fracture line over time are indicative of healing. Imaging must be combined with clinical parameters and patient-reported outcomes. Animal data support a negative effect of osteoporosis on fracture healing; however, clinical data do not appear to corroborate with this. Evidence does not support a delay in the initiation of antiresorptive therapy following acute fragility fractures. There is no reason for suspension of osteoporosis medication at the time of fracture if the person is already on treatment. Teriparatide treatment may shorten fracture healing time at certain sites such as distal radius; however, it does not prevent non-union or influence union rate. The positive effect on fracture healing that romosozumab has demonstrated in animals has not been observed in humans. CONCLUSION: Overall, there appears to be no deleterious effect of osteoporosis medications on fracture healing. The benefit of treating osteoporosis and the urgent necessity to mitigate imminent refracture risk after a fracture should be given prime consideration. It is imperative that new radiological and biological markers of fracture healing be identified. It is also important to synthesize clinical and basic science methodologies to assess fracture healing, so that a convergence of the two frameworks can be achieved.


Subject(s)
Bone Density Conservation Agents , Fracture Healing , Osteoporosis , Osteoporotic Fractures , Humans , Fracture Healing/drug effects , Fracture Healing/physiology , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/pharmacology , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/physiopathology , Osteoporosis/drug therapy , Osteoporosis/physiopathology , Teriparatide/therapeutic use , Teriparatide/pharmacology , Animals , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal/pharmacology
14.
Osteoporos Int ; 35(7): 1173-1183, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38565690

ABSTRACT

This study evaluated the cost-effectiveness of sequential treatment with romosozumab-to-alendronate compared to alendronate monotherapy and teriparatide-to-alendronate, in postmenopausal osteoporotic women from a Belgian healthcare perspective. Romosozumab-to-alendronate was found to be cost-effective compared to alendronate monotherapy and dominant compared to teriparatide-to-alendronate for osteoporotic women at high risk of fracture in Belgium. PURPOSE: This study aimed to evaluate the cost-effectiveness of sequential treatment with romosozumab followed by alendronate compared to alendronate monotherapy and teriparatide followed by alendronate, in postmenopausal osteoporotic women at high risk of fracture, from a Belgian healthcare perspective. Romosozumab is reimbursed in Belgium since December 2021. METHODS: A Markov microsimulation model was used to evaluate the cost-effectiveness of romosozumab-to-alendronate compared to alendronate monotherapy and to teriparatide-to-alendronate over a lifetime horizon. Patients transition between five different health states every 6 months based on fracture risks or death. The model was populated with Belgium-specific epidemiological and cost data, where available. The fracture risk reduction of romosozumab treatment was collated from the ARCH study, and from a published network meta-analysis. Costs were included from a healthcare perspective (NIHDI). Cost-effectiveness was reported in terms of costs per quality-adjusted life year (QALY), reported in Euro (€) 2022. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were performed. RESULTS: Romosozumab-to-alendronate was associated with 0.12 additional QALYs at an additional cost of €2314 compared to alendronate monotherapy, resulting in an ICER of €19,978. Compared to teriparatide-to-alendronate, romosozumab-to-alendronate was found to be dominant, with higher QALYs and lower costs. The base-case results were robust to uncertainty in the input parameters when conducting the sensitivity analysis. CONCLUSION: Sequential treatment with romosozumab followed by alendronate was found to be cost-effective compared to alendronate monotherapy and dominant compared to teriparatide followed by alendronate for postmenopausal women with osteoporosis at high risk of fracture in Belgium.


Subject(s)
Alendronate , Antibodies, Monoclonal , Bone Density Conservation Agents , Cost-Benefit Analysis , Drug Costs , Markov Chains , Osteoporosis, Postmenopausal , Osteoporotic Fractures , Quality-Adjusted Life Years , Teriparatide , Humans , Female , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/economics , Osteoporotic Fractures/epidemiology , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/economics , Belgium/epidemiology , Osteoporosis, Postmenopausal/drug therapy , Osteoporosis, Postmenopausal/economics , Osteoporosis, Postmenopausal/complications , Alendronate/therapeutic use , Alendronate/economics , Alendronate/administration & dosage , Teriparatide/therapeutic use , Teriparatide/economics , Teriparatide/administration & dosage , Aged , Drug Costs/statistics & numerical data , Antibodies, Monoclonal/economics , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal/administration & dosage , Drug Therapy, Combination , Middle Aged , Drug Administration Schedule , Drug Substitution/economics , Drug Substitution/statistics & numerical data
15.
Osteoporos Int ; 35(7): 1299-1302, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38613637

ABSTRACT

INTRODUCTION: Transient hypercalcaemia due to teriparatide occurs in up to 11% of patients though delayed hypercalcaemia (> 24 h post injection) is rare. We report the case of a female who developed significant delayed hypercalcaemia after teriparatide treatment for osteoporosis and review other cases in the literature to date. CASE REPORT: A 72-year-old female on teriparatide for the treatment of osteoporosis was found to have hypercalcaemia (3.30 mmol/l) on routine testing approximately 3 months after starting therapy. Serum calcium pretreatment was normal at 2.39 mmol/l. She was admitted to the hospital for investigations which identified a serum 25-hydroxyvitamin D of 94 nmol/l, a low parathyroid hormone of 6.0 pg/ml, and normal test results for 1,25 dihydroxyvitamin D (115 pmol/l), parathyroid hormone-related peptide (< 1.4 pmol/ml), serum electrophoresis and angiotensin-converting enzyme (39 IU/l). CT abdomen, pelvis, and thorax revealed no evidence of malignancy and an isotope bone scan ruled out skeletal metastases. Serum calcium normalised (2.34 mmol/l) several days after stopping teriparatide and calcium supplements and administering intravenous fluid. On restarting teriparatide, delayed hypercalcaemia reoccurred and treatment was switched to denosumab. DISCUSSION: Delayed moderate to severe hypercalcaemia (serum calcium > 3.0 mmol/l) due to teriparatide is rare but may lead to therapy withdrawal. The underlying predisposing risk factors remain unclear and highlight the importance of a routine serum calcium assessment on therapy.


Subject(s)
Bone Density Conservation Agents , Hypercalcemia , Teriparatide , Humans , Hypercalcemia/chemically induced , Hypercalcemia/drug therapy , Hypercalcemia/blood , Teriparatide/therapeutic use , Female , Aged , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/adverse effects , Calcium/blood , Osteoporosis/drug therapy , Osteoporosis, Postmenopausal/drug therapy
17.
BMC Musculoskelet Disord ; 25(1): 288, 2024 Apr 13.
Article in English | MEDLINE | ID: mdl-38614984

ABSTRACT

BACKGROUND: Teriparatide, a recombinant parathyroid hormone, is pivotal in osteoporosis treatment, particularly in post-surgical recovery for hip fractures. This study investigates its efficacy in functional recovery post-hip fracture surgery in elderly patients, a demographic particularly susceptible to osteoporotic fractures. METHODS: In this retrospective cohort study, 150 elderly patients with proximal femoral fractures undergoing open reduction and internal fixation were enrolled. They were categorized into two groups: receiving 20 µg of daily teriparatide injections for 18 months and receiving standard antiresorptive medications during a 24-month follow-up. Detailed records of patient demographics, Fracture Risk Assessment Tool scores, and comorbidities were kept. Key outcomes, including bone mineral density (BMD) and functional scores (Barthel Index and Visual Analog Scale for hip pain), were evaluated at 3 and 24 months post-surgery. RESULTS: Out of the original cohort, 126 patients (20 men and 106 women with an average age of 85.5 ± 9.3 years) completed the study. The teriparatide group exhibited significant enhancements in both functional scores and BMD when compared to the control group. Notably, functional improvements were less pronounced in male patients compared to female patients. Additionally, the incidence of new fractures was markedly lower in the teriparatide group. CONCLUSION: Administering teriparatide daily for 18 months post-surgery for proximal femoral fractures significantly benefits very elderly patients by improving functionality and bone density, with observed differences in recovery between genders. These results reinforce the efficacy of teriparatide as a potent option for treating osteoporosis-related fractures in the elderly and highlight the importance of considering gender-specific treatment and rehabilitation strategies.


Subject(s)
Hip Fractures , Osteoporosis , Proximal Femoral Fractures , Aged , Female , Humans , Male , Aged, 80 and over , Teriparatide/therapeutic use , Bone Density , Retrospective Studies , Hip Fractures/surgery , Osteoporosis/complications , Osteoporosis/drug therapy
18.
Int J Implant Dent ; 10(1): 18, 2024 Apr 16.
Article in English | MEDLINE | ID: mdl-38625587

ABSTRACT

PURPOSE: Osteoporotic individuals who have dental implants usually require a prolonged healing time for osseointegration due to the shortage of bone mass and the lack of initial stability. Although studies have shown that intermittent teriparatide administration can promote osseointegration, there is little data to support the idea that pre-implantation administration is necessary and beneficial. METHODS: Sixty-four titanium implants were placed in the bilateral proximal tibial metaphysis in 32 female SD rats. Bilateral ovariectomy (OVX) was used to induce osteoporosis. Four major groups (n = 8) were created: PRE (OVX + pre-implantation teriparatide administration), POST (OVX + post-implantation administration), OP (OVX + normal saline (NS)) and SHAM (sham rats + NS). Half of rats (n = 4) in each group were euthanized respectively at 4 weeks or 8 weeks after implantation surgery, and four major groups were divided into eight subgroups (PRE4 to SHAM8). Tibiae were collected for micro-CT morphometry, biomechanical test and undecalcified sections analysis. RESULTS: Compared to OP group, rats in PRE and SHAM groups had a higher value of insertion torque (p < 0.05). The micro-CT analysis, biomechanical test, and histological data showed that peri-implant trabecular growth, implants fixation and bone-implant contact (BIC) were increased after 4 or 8 weeks of teriparatide treatment (p < 0.05). There was no statistically difference in those parameters between PRE4 and POST8 subgroups (p > 0.05). CONCLUSIONS: In osteoporotic rats, post-implantation administration of teriparatide enhanced peri-implant bone formation and this effect was stronger as the medicine was taken longer. Pre-implantation teriparatide treatment improved primary implant stability and accelerated the osseointegration process.


Subject(s)
Dental Implants , Teriparatide , Female , Animals , Rats , Rats, Sprague-Dawley , Teriparatide/pharmacology , Teriparatide/therapeutic use , Osseointegration , Embryo Implantation , Saline Solution
19.
Arch Osteoporos ; 19(1): 19, 2024 Mar 21.
Article in English | MEDLINE | ID: mdl-38512565

ABSTRACT

This retrospective study compared the efficacy of anabolic agents (romosozumab and teriparatide) with that of alendronate in preventing subsequent vertebral body fractures (SVBFs) after balloon kyphoplasty (BKP). All anabolic agents significantly reduced SVBFs. Romosozumab was most effective in increasing bone mineral density (BMD) and completely suppressed distant vertebral body fractures. INTRODUCTION: To determine optimal anti-osteoporosis medications, we compared romosozumab and teriparatide to alendronate as a control from perioperative BKP to the 1st postoperative year for treatment and secondary fracture prevention in osteoporosis. METHODS: A total of 603 patients who underwent initial BKP for osteoporotic vertebral fractures were evaluated and categorized into five groups based on drug administration: romosozumab (group R, 155 patients), twice-weekly teriparatide (group TW, 48), weekly teriparatide (group W, 151), daily teriparatide (group D, 138), and alendronate (control) (group C, 111). The 1-year incidence of SVBFs, BMD change rate, and probability of requiring BKP were compared among the groups. RESULTS: SVBF incidence was 3.9%, 6.5%, 8.3%, 6.0%, and 14.4% in groups R, D, TW, W, and C, respectively, with all other groups exhibiting significantly lower rates than group C. The groups that administered the anabolic agents had a notably lower incidence of distant fractures than group C. Compared with group C, group R showed significantly higher BMD change rates in lumbar vertebral bodies at 4, 8, and 12 months and group D at 12 months. Anabolic agent groups exhibited significantly higher improvement rates than group C after conservative treatment alone. CONCLUSION: The anabolic agents were found to be more effective at reducing the incidence of SVBF (especially distant vertebral fractures) than alendronate. These agents decreased the rate of repeat BKP even after the occurrence of a fracture. Overall, the use of an anabolic agent for the treatment of osteoporosis after BKP is better than the use of alendronate, even when treatment is initiated in the perioperative stage.


Subject(s)
Anabolic Agents , Bone Density Conservation Agents , Fractures, Compression , Kyphoplasty , Osteoporosis , Osteoporotic Fractures , Spinal Fractures , Humans , Vertebral Body , Teriparatide/therapeutic use , Alendronate/therapeutic use , Retrospective Studies , Anabolic Agents/pharmacology , Anabolic Agents/therapeutic use , Osteoporosis/drug therapy , Osteoporosis/complications , Osteoporotic Fractures/therapy , Bone Density , Spinal Fractures/complications , Fractures, Compression/surgery , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/pharmacology
20.
J Med Case Rep ; 18(1): 142, 2024 Mar 08.
Article in English | MEDLINE | ID: mdl-38454520

ABSTRACT

BACKGROUND: Complex regional pain syndrome type I is a pathological condition characterized by an exaggerated response of tissues to low or moderate pain stimuli. The exact pathogenesis and optimal medical treatment for complex regional pain syndrome type I are still not fully understood, although bisphosphonates have shown positive effects in reducing pain. Foot surgery can be complicated by the development of complex regional pain syndrome type I, leading to functional decline and difficulties in weight-bearing. CASE PRESENTATION: The authors present a clinical case involving complex regional pain syndrome type I that developed after surgical foot arthrodesis. The patient, a 42-year-old Caucasian male, did not respond to clodronate treatment but experienced successful outcomes upon the addition of teriparatide, which effectively stimulated the healing of arthrodesis. CONCLUSION: Teriparatide cannot be considered the primary treatment for complex regional pain syndrome due to insufficient solid clinical data. However, when complex regional pain syndrome is associated with or caused by delayed union, teriparatide can be used to address the underlying cause of complex regional pain syndrome.


Subject(s)
Bone Density Conservation Agents , Complex Regional Pain Syndromes , Male , Humans , Adult , Teriparatide/therapeutic use , Bone Density Conservation Agents/therapeutic use , Clodronic Acid , Pain/drug therapy , Complex Regional Pain Syndromes/drug therapy
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