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Osteoporosis Treatment: Recent Developments and Ongoing Challenges

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A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Orthopedics".

Deadline for manuscript submissions: closed (31 March 2021) | Viewed by 65676

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Special Issue Editors

Prof. Dr. Martina Rauner

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Guest Editor

Department of Medicine III & Center for Healthy Aging, Medical Faculty of the Technische Universität Dresden, Fetscherstr. 74, 01307 Dresden, Germany
Interests: bone regeneration; osteoporosis; bone osteoclast

Dr. Elizabeth Winter

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Guest Editor

Department of Medicine, Division of Endocrinology & Center for Bone Quality, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands
Interests: osteoporosis; sternocostoclavicular hyperostosis; adolescent circadian rhythms

Prof. Dr. Andrea Burden

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Guest Editor

Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zürich, HCI H407, Vladimir-Prelog-Weg 4, HCI H407, CH-8093 Zurich, Switzerland
Interests: osteoporosis; pharmacoepidemiology; pharmacy; epidemiology and public health; fracture
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Special Issue Information

Dear Colleagues,

Osteoporosis is one of the most prevalent musculoskeletal diseases in the Western countries, with increasing prevalence among the elderly. The primary clinical consequence of osteoporosis are bone fractures due to increased bone fragility. Fractures are associated with pain, extensive hospitalization and rehabilitation time, loss of autonomy, and even increased mortality. Therefore, effective treatments for osteoporosis are required that can reduce the occurrence of fractures and related costs.

A number of treatment options are available for osteoporosis including the anti-resorptive drugs bisphosphonates and denosumab, which primarily block bone resorption, and bone-anabolic drugs, such as teriparatide and romosozumab, which lead to active formation of new bone. As osteoporosis is a chronic disease, it requires lifelong treatment. While there is now longstanding experience with anti-resorptives, previously unknown issues are arising, such as how to terminate therapy or how to deal with long-term compliance. Conversely, romosozumab is just entering clinical practice with the warning of potential cardiovascular side effects which thus needs to be addressed, and the use of teriparatide is limited to 24 months, thereby requiring a good follow-up treatment plan similar to that of denosumab.

Thus, while there are a number of effective therapies for osteoporosis management, they all have their specific limitations and opportunities. These topics will be highlighted and discussed in this Special Issue of JCM.

Prof. Dr. Martina Rauner
Dr. Elizabeth Winter
Prof. Dr. Andrea Burden
Guest Editors

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Keywords

Osteoporosis
Conventional therapies
Emerging therapies
Sequential therapy
Physical therapy
Treatment compliance
Duration and ceasing of therapies
Real-world data analyses

Published Papers (12 papers)

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Research

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11 pages, 1047 KiB

Open AccessArticle

Sarcopenia and Malnutrition Screening in Female Osteoporosis Patients—A Cross-Sectional Study

by Franca Genest, Dominik Rak, Elisa Bätz, Kerstin Ott and Lothar Seefried

J. Clin. Med. 2021, 10(11), 2344; https://doi.org/10.3390/jcm10112344 - 27 May 2021

Cited by 1 | Viewed by 1711

Abstract

Sarcopenia and malnutrition are important determinants of increased fracture risk in osteoporosis. SARC-F and MNA-SF are well-established questionnaires for identifying patients at risk for these conditions. We sought to evaluate the feasibility and potential added benefit of such assessments as well as the actual prevalence of these conditions in osteoporosis patients. We conducted a cross-sectional, single-center study in female osteoporosis patients ≥ 65 years (SaNSiBaR-study). Results of the sarcopenia (SARC-F) and malnutrition (MNA-SF) screening questionnaires were matched with a functional assessment for sarcopenia and data from patients’ medical records. Out of 107 patients included in the analysis, a risk for sarcopenia (SARC-F ≥ 4 points) and a risk for malnutrition (MNA-SF ≤ 11 points) was found in 33 (30.8%) and 38 (35.5%) patients, respectively. Diagnostic overlap with coincident indicative findings in both questionnaires was observed in 17 patients (16%). As compared to the respective not-at-risk groups, the mean short physical performance battery (SPPB) score was significantly reduced in both patients at risk for sarcopenia (7.0 vs. 10.9 points, p < 0.001) and patients at risk for malnutrition (8.7 vs. 10.5 points, p = 0.005). Still, confirmed sarcopenia according to EWGSOP2 criteria was present in only 6 (6%) of all 107 patients, with only 3 of them having an indicative SARC-F score. Bone mineral density was not significantly different in any of the at-risk groups at any site. In summary, applying SARC-F and MNA-SF in osteoporosis patients appears to be a complementary approach to identify individuals with functional deficits. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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14 pages, 1518 KiB

Open AccessArticle

Cardiovascular Safety Profile of Romosozumab: A Pharmacovigilance Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS)

by Annika Vestergaard Kvist, Junaid Faruque, Enriqueta Vallejo-Yagüe, Stefan Weiler, Elizabeth M. Winter and Andrea M. Burden

J. Clin. Med. 2021, 10(8), 1660; https://doi.org/10.3390/jcm10081660 - 13 Apr 2021

Cited by 25 | Viewed by 5381

Abstract

Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39–6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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9 pages, 1686 KiB

Open AccessArticle

Reduced Awareness for Osteoporosis in Distal Radius Fracture Patients Compared to Patients with Proximal Femur Fractures

by Alexander Martin Keppler, Moritz Kraus, Matthias Blaschke, Nicole Thomasser, Christian Kammerlander, Wolfgang Böcker, Carl Neuerburg and Ulla Cordula Stumpf

J. Clin. Med. 2021, 10(4), 848; https://doi.org/10.3390/jcm10040848 - 19 Feb 2021

Cited by 7 | Viewed by 1906

Abstract

Purpose: The present study is aiming to evaluate patients’ awareness to participate in further diagnostics for osteoporosis and to find out if there are significant differences with regards to fracture site. Methods: Patients at risk for underlying osteoporosis (female >60 and male >70 years) undergoing surgical treatment for a distal radius fracture (DRF) or a proximal femur fracture (PFF) were asked to complete a questionnaire assessing the awareness for underlying osteoporosis. Furthermore, dual-X-ray absorptiometry (DXA) scans were analyzed. Results: Overall, 150 patients (w = 122/m = 28, mean age 79.9 years (±8.6)) were included, of these, 36 patients suffered a DRF and 114 patients a PFF. Of these, 68 out of the 150 patients (45.3%) considered that an examination was necessary, whereas in PFF patients the awareness was higher than in the DRF Group (41% vs. 32%). Conclusions: The patients’ willingness to undergo further diagnostics for osteoporosis was generally poor. DRFs are frequently accompanied by a lower limitation of quality of life compared to PFF, which might be causative for even poorer awareness in these patients. Especially younger patients (age 60–70 years) with a distal radius fracture seemed to underestimate osteoporosis. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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Review

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13 pages, 678 KiB

Open AccessReview

The Treatment Gap in Osteoporosis

by Nazia Ayub, Malak Faraj, Sam Ghatan, Joannes A. A. Reijers, Nicola Napoli and Ling Oei

J. Clin. Med. 2021, 10(13), 3002; https://doi.org/10.3390/jcm10133002 - 05 Jul 2021

Cited by 33 | Viewed by 7553

Abstract

Worldwide, there are millions of people who have been diagnosed with osteoporosis, a bone disease that increases the risk of fracture due to low bone mineral density and deterioration of bone architecture. In the US alone, there are approximately ten million men and women diagnosed with osteoporosis and this number is still growing. Diagnosis is made by measuring bone mineral density. Medications used for the treatment of osteoporosis are bisphosphonates, denosumab, raloxifene, and teriparatide. Recently, romosozumab has been added as well. In recent years, a number of advances have been made in the field of diagnostic methods and the diverse treatment options for osteoporosis. Despite these advances and a growing incidence of osteoporosis, there is a large group being left undertreated or even untreated. This group of the under/untreated has been called the treatment gap. Concerns regarding rare side effects of the medications, such as osteonecrosis of the jaw, have been reported to be one of the many causes for the treatment gap. Also, this group seems not to be sufficiently informed of the major benefits of the treatment and the diversity in treatment options. Knowledge of these could be very helpful in improving compliance and hopefully reducing the gap. In this paper, we summarize recent evidence regarding the efficacy of the various treatment options, potential side effects, and the overall benefit of treatment. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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17 pages, 347 KiB

Open AccessReview

An Up-Date of the Muscle Strengthening Exercise Effectiveness in Postmenopausal Women with Osteoporosis: A Qualitative Systematic Review

by Jose Luis Alonso Pérez, Sebastián Martín Pérez, Andrea Battaglino, Jorge H. Villafañe, Alexandra Alonso-Sal and Eleuterio A. Sánchez Romero

J. Clin. Med. 2021, 10(11), 2229; https://doi.org/10.3390/jcm10112229 - 21 May 2021

Cited by 18 | Viewed by 4330

Abstract

Background: Osteoporosis (OP) is a systemic disease that is characterized by decreased bone density and quality. Purpose: The purpose of this systematic review was to determine the effects of muscle strengthening exercise in postmenopausal women with OP. Methods: A literature search was conducted systematically in MEDLINE, CINAHL, EMBASE databases for human studies up to 31 March 2021. Two researchers screened the articles against predefined inclusion criteria; a third resolved discrepancies. Articles were included if they assessed the effects of muscle strengthening exercise in postmenopausal women with OP. The protocol for this systematic review was registered on PROSPERO (CRD42021207917) and a qualitative systematic review was carried out following the PRISMA statement. Methodological quality was evaluated through the scientific validity scales PEDro. Finally, RTCs and NRCTs risk of bias was assessed with the Cochrane risk of bias tool (Risk of Bias-ROB 2.0) and ROBINS-1, respectively. Results: A total of 16 studies (1028 subjects) that met the different eligibility criteria previously established were selected. There is evidence of good methodological quality and a low to moderate risk of bias that supports that muscle strengthening exercise alone or in combination with other therapeutic modalities improves BMD (9, n = 401) in proximal femur and lumbar vertebra body, muscle strength (10, n = 558), balance (4, n = 159), functionality (7, n = 617), and quality of life (5, n = 291). Conclusions: Exercise programs focused on muscle strengthening have benefits for all variables studied in postmenopausal women with OP. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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12 pages, 2497 KiB

Open AccessReview

Review of Current Real-World Experience with Teriparatide as Treatment of Osteoporosis in Different Patient Groups

by Barbara Hauser, Nerea Alonso and Philip L Riches

J. Clin. Med. 2021, 10(7), 1403; https://doi.org/10.3390/jcm10071403 - 01 Apr 2021

Cited by 12 | Viewed by 5003

Abstract

Teriparatide has proven effective in reducing both vertebral and non-vertebral fractures in clinical trials of post-menopausal and glucocorticoid-induced osteoporosis. Widespread adoption of Teriparatide over the last two decades means that there is now substantial experience of its use in routine clinical practice, which is summarized in this paper. Extensive real-world experience of Teriparatide in post-menopausal osteoporosis confirms the fracture and bone density benefits seen in clinical trials, with similar outcomes identified also in male and glucocorticoid-induced osteoporosis. Conversely, very limited experience has been reported in pre-menopausal osteoporosis or in the use of Teriparatide in combination with other therapies. Surveillance studies have identified no safety signals relating to the possible association of Teriparatide with osteosarcoma. We also review the evidence for predicting response to Teriparatide in order to inform the debate on where best to use Teriparatide in an increasingly crowded therapeutic landscape. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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12 pages, 1889 KiB

Open AccessReview

Managing Osteoporosis and Joint Damage in Patients with Rheumatoid Arthritis: An Overview

by Yoshiya Tanaka

J. Clin. Med. 2021, 10(6), 1241; https://doi.org/10.3390/jcm10061241 - 17 Mar 2021

Cited by 24 | Viewed by 3515

Abstract

In rheumatoid arthritis, a representative systemic autoimmune disease, immune abnormality and accompanying persistent synovitis cause bone and cartilage destruction and systemic osteoporosis. Biologics targeting tumor necrosis factor, which plays a central role in the inflammatory process, and Janus kinase inhibitors have been introduced in the treatment of rheumatoid arthritis, making clinical remission a realistic treatment goal. These drugs can prevent structural damage to bone and cartilage. In addition, osteoporosis, caused by factors such as menopause, aging, immobility, and glucocorticoid use, can be treated with bisphosphonates and the anti-receptor activator of the nuclear factor-κB ligand antibody. An imbalance in the immune system in rheumatoid arthritis induces an imbalance in bone metabolism. However, osteoporosis and bone and cartilage destruction occur through totally different mechanisms. Understanding the mechanisms underlying osteoporosis and joint destruction in rheumatoid arthritis leads to improved care and the development of new treatments. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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12 pages, 297 KiB

Open AccessReview

Duration of Bisphosphonate Drug Holidays in Osteoporosis Patients: A Narrative Review of the Evidence and Considerations for Decision-Making

by Kaleen N. Hayes, Elizabeth M. Winter, Suzanne M. Cadarette and Andrea M. Burden

J. Clin. Med. 2021, 10(5), 1140; https://doi.org/10.3390/jcm10051140 - 09 Mar 2021

Cited by 22 | Viewed by 4582

Abstract

Bisphosphonates are first-line therapy for osteoporosis, with alendronate, risedronate, and zoledronate as the main treatments used globally. After one year of therapy, bisphosphonates are retained in bone for extended periods with extended anti-fracture effects after discontinuation. Due to this continued fracture protection and the potential for rare adverse events associated with long-term use (atypical femoral fractures and osteonecrosis of the jaw), a drug holiday of two to three years is recommended for most patients after long-term bisphosphonate therapy. The recommendation for a drug holiday up to three years is derived primarily from extensions of pivotal trials with alendronate and zoledronate and select surrogate marker studies. However, certain factors may modify the duration of bisphosphonate effects on a drug holiday and warrant consideration when determining an appropriate time off-therapy. In this narrative review, we recall what is currently known about drug holidays and discuss what we believe to be the primary considerations and areas for future research regarding drug holiday duration: total bisphosphonate exposure, type of bisphosphonate used, bone mineral density and falls risk, and patient sex and body weight. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

17 pages, 909 KiB

Open AccessReview

The Impact of Antiosteoporotic Drugs on Glucose Metabolism and Fracture Risk in Diabetes: Good or Bad News?

by Athanasios D. Anastasilakis, Elena Tsourdi, Gaia Tabacco, Anda Mihaela Naciu, Nicola Napoli, Fabio Vescini and Andrea Palermo

J. Clin. Med. 2021, 10(5), 996; https://doi.org/10.3390/jcm10050996 - 02 Mar 2021

Cited by 13 | Viewed by 4480

Abstract

Osteoporosis and diabetes mellitus represent global health problems due to their high, and increasing with aging, prevalence in the general population. Osteoporosis can be successfully treated with both antiresorptive and anabolic drugs. While these drugs are clearly effective in reducing the risk of fracture in patients with postmenopausal and male osteoporosis, it is still unclear whether they may have the same efficacy in patients with diabetic osteopathy. Furthermore, as bone-derived cytokines (osteokines) are able to influence glucose metabolism, it is conceivable that antiosteoporotic drugs may have an effect on glycemic control through their modulation of bone turnover that affects the osteokines’ release. These aspects are addressed in this narrative review by means of an unrestricted computerized literature search in the PubMed database. Our findings indicate a balance between good and bad news. Active bone therapies and their modulation of bone turnover do not appear to play a clinically significant role in glucose metabolism in humans. Moreover, there are insufficient data to clarify whether there are any differences in the efficacy of antiosteoporotic drugs on fracture incidence between diabetic and nondiabetic patients with osteoporosis. Although more studies are required for stronger recommendations to be issued, bisphosphonates appear to be the first-line drug for treatment of osteoporosis in diabetic patients, while denosumab seems preferable for older patients, particularly for those with impaired renal function, and osteoanabolic agents should be reserved for patients with more severe forms of osteoporosis. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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21 pages, 484 KiB

Open AccessReview

Osteoporosis Treatment with Anti-Sclerostin Antibodies—Mechanisms of Action and Clinical Application

by Martina Rauner, Hanna Taipaleenmäki, Elena Tsourdi and Elizabeth M. Winter

J. Clin. Med. 2021, 10(4), 787; https://doi.org/10.3390/jcm10040787 - 16 Feb 2021

Cited by 32 | Viewed by 8696

Abstract

Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risk of fragility fractures and significant long-term disability. Although both anti-resorptive treatments and osteoanabolic drugs, such as parathyroid hormone analogues, are effective in fracture prevention, limitations exist due to lack of compliance or contraindications to these drugs. Thus, there is a need for novel potent therapies, especially for patients at high fracture risk. Romosozumab is a monoclonal antibody against sclerostin with a dual mode of action. It enhances bone formation and simultaneously suppresses bone resorption, resulting in a large anabolic window. In this opinion-based narrative review, we highlight the role of sclerostin as a critical regulator of bone mass and present human diseases of sclerostin deficiency as well as preclinical models of genetically modified sclerostin expression, which led to the development of anti-sclerostin antibodies. We review clinical studies of romosozumab in terms of bone mass accrual and anti-fracture activity in the setting of postmenopausal and male osteoporosis, present sequential treatment regimens, and discuss its safety profile and possible limitations in its use. Moreover, an outlook comprising future translational applications of anti-sclerostin antibodies in diseases other than osteoporosis is given, highlighting the clinical significance and future scopes of Wnt signaling in these settings. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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28 pages, 1843 KiB

Open AccessReview

Denosumab Discontinuation and the Rebound Phenomenon: A Narrative Review

by Athanasios D. Anastasilakis, Polyzois Makras, Maria P. Yavropoulou, Gaia Tabacco, Anda Mihaela Naciu and Andrea Palermo

J. Clin. Med. 2021, 10(1), 152; https://doi.org/10.3390/jcm10010152 - 04 Jan 2021

Cited by 85 | Viewed by 9480

Abstract

Denosumab is a potent antiresorptive agent that substantially increases bone mineral density and reduces fracture rates at all skeletal sites for as long as it is administered. However, its favorable skeletal effects reverse quickly upon its discontinuation, because of a vast increase of osteoclast number and activity, which leads to a subsequent profound increase of bone turnover above pre-treatment values, a phenomenon commonly described as “rebound phenomenon”. More importantly, most patients experience rapid, profound bone loss due to this burst of bone resorption that may lead in a minority of these patients to occurrence of fractures, especially multiple vertebral fractures. Therefore, subsequent antiresorptive treatment is mandatory, although the optimal regimen is yet to be clarified. In the present review, we outline what is currently known regarding the negative effects of denosumab discontinuation on different aspects of bone status, the factors that may affect them, and strategies to prevent them. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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16 pages, 761 KiB

Open AccessReview

Anti-Sclerostin Antibodies in Osteoporosis and Other Bone Diseases

by Stéphanie Fabre, Thomas Funck-Brentano and Martine Cohen-Solal

J. Clin. Med. 2020, 9(11), 3439; https://doi.org/10.3390/jcm9113439 - 26 Oct 2020

Cited by 48 | Viewed by 7219

Abstract

The Wnt pathway is a key element of bone remodeling; its activation stimulates bone formation and inhibits bone resorption. The discovery of sclerostin, a natural antagonist of the Wnt pathway, promoted the development of romosozumab, a human monoclonal antibody directed against sclerostin, as well as other anti-sclerostin antibodies. Phase 3 studies have shown the efficacy of romosozumab in the prevention of fractures in postmenopausal women, against placebo but also against alendronate or teriparatide and this treatment also allows bone mineral density (BMD) increase in men. Romosozumab induces the uncoupling of bone remodeling, leading to both an increase in bone formation and a decrease in bone resorption during the first months of treatment. The effect is attenuated over time and reversible when stopped but transition with anti-resorbing agents allows the maintenance or reinforcement of BMD improvements. Some concerns were raised about cardiovascular events. Therefore, romosozumab was recently approved in several countries for the treatment of severe osteoporosis in postmenopausal women with high fracture risk and without a history of heart attack, myocardial infarction or stroke. This review aims to outline the role of sclerostin, the efficacy and safety of anti-sclerostin therapies and in particular romosozumab and their place in therapeutic strategies against osteoporosis or other bone diseases. Full article

(This article belongs to the Special Issue Osteoporosis Treatment: Recent Developments and Ongoing Challenges)

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