Patient preference for monthly bisphosphonate versus weekly bisphosphonate in a cluster-randomized, open-label, crossover trial: Minodroate Alendronate/Risedronate Trial in Osteoporosis (MARTO)

Iwamoto, Jun; Okano, Hiroya; Furuya, Takefumi; Urano, Tomohiko; Hasegawa, Masaichi; Hirabayashi, Hisashi; Kumakubo, Takami; Makita, Kazuya

doi:10.1007/s00774-015-0653-7

Cited by 14 publications

(15 citation statements)

References 19 publications

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“…This profoundly alters its properties in terms of reducing its mineral binding with a modest reduction in its IC 50 on FPPS. MIN has emerged as probably the most potent bisphosphonate to be approved for clinical use by this FPPS measure, but is only used in Japan . This illustrates how apparently small differences in chemical structure can produce large changes in pharmacological properties, as has been observed with many other apparently closely related bisphosphonates.…”

Section: Discussionmentioning

confidence: 92%

The Pharmacological Profile of a Novel Highly Potent Bisphosphonate, OX14 (1-Fluoro-2-(Imidazo-[1,2-α]Pyridin-3-yl)-Ethyl-Bisphosphonate)

Lawson

Ebetino

Mazur³

et al. 2017

Journal of Bone and Mineral Research

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Bisphosphonates are widely used in the treatment of clinical disorders characterized by increased bone resorption, including osteoporosis, Paget's disease, and the skeletal complications of malignancy. The antiresorptive potency of the nitrogen‐containing bisphosphonates on bone in vivo is now recognized to depend upon two key properties, namely mineral binding affinity and inhibitory activity on farnesyl pyrophosphate synthase (FPPS), and these properties vary independently of each other in individual bisphosphonates. The better understanding of structure activity relationships among the bisphosphonates has enabled us to design a series of novel bisphosphonates with a range of mineral binding properties and antiresorptive potencies. Among these is a highly potent bisphosphonate, 1‐fluoro‐2‐(imidazo‐[1,2 alpha]pyridin‐3‐yl)‐ethyl‐bisphosphonate, also known as OX14, which is a strong inhibitor of FPPS, but has lower binding affinity for bone mineral than most of the commonly studied bisphosphonates. The aim of this work was to characterize OX14 pharmacologically in relation to several of the bisphosphonates currently used clinically. When OX14 was compared to zoledronate (ZOL), risedronate (RIS), and minodronate (MIN), it was as potent at inhibiting FPPS in vitro but had significantly lower binding affinity to hydroxyapatite (HAP) columns than ALN, ZOL, RIS, and MIN. When injected i.v. into growing Sprague Dawley rats, OX14 was excreted into the urine to a greater extent than the other bisphosphonates, indicating reduced short‐term skeletal uptake and retention. In studies in both Sprague Dawley rats and C57BL/6J mice, OX14 inhibited bone resorption, with an antiresorptive potency equivalent to or greater than the comparator bisphosphonates. In the JJN3‐NSG murine model of myeloma‐induced bone disease, OX14 significantly prevented the formation of osteolytic lesions (p < 0.05). In summary, OX14 is a new, highly potent bisphosphonate with lower bone binding affinity than other clinically relevant bisphosphonates. This renders OX14 an interesting potential candidate for further development for its potential skeletal and nonskeletal benefits. © 2017 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.

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Section: Discussionmentioning

confidence: 92%

The Pharmacological Profile of a Novel Highly Potent Bisphosphonate, OX14 (1-Fluoro-2-(Imidazo-[1,2-α]Pyridin-3-yl)-Ethyl-Bisphosphonate)

Lawson

Ebetino

Mazur³

et al. 2017

Journal of Bone and Mineral Research

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“…In Japan, monthly oral formulation for minodronate was launched in 2011 and risedronate in 2013. A recent study showed a strong patient preference for and convenience of a monthly bisphosphonate regimen over a weekly bisphosphonate regimen among Japanese patients with osteoporosis [ 31 ]. Visiting hospitals or clinics to receive an intravenous injection or drip of a bisphosphonate monthly may improve treatment adherence.…”

Section: Discussionmentioning

confidence: 99%

Hip fracture incidence in Japan: Estimates of new patients in 2012 and 25-year trends

Orimo¹,

Yaegashi

Hosoi³

et al. 2016

Osteoporos Int

135

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SummaryWe estimated the number of hip fracture patients in 2012 in Japan and investigated the trends in incidence during a 25-year period from 1987 to 2012. Despite the increasing number of patients, the incidence of hip fracture in both men and women aged 70–79 years showed the possibility of decline.IntroductionThe objectives of this study were to estimate the number of hip fracture patients in 2012, to investigate the trends in incidence during a 25-year period from 1987 to 2012, and to determine the regional differences in Japan.MethodsData were collected through a nationwide survey based on hospitals by a mail-in survey. Hip fracture incidences by sex and age and standardized incidence ratios by region were calculated.ResultsThe estimated numbers of new hip fracture patients in 2012 were 175,700 in total (95 % CI 170,300–181,100), 37,600 (36,600–38,600) for men and 138,100 (134,300–141,900) for women. The incidence rates in both men and women aged 70–79 years were the lowest in the 20-year period from 1992 to 2012. The incidence was higher in western areas of Japan than that in eastern areas in both men and women; however, the difference in the incidence of hip fracture between western and eastern areas is becoming smaller.ConclusionsDespite the increasing number of new patients, the incidence of hip fracture in both men and women aged 70–79 years showed the possibility of decline. The exact reasons for this are unknown, but various drugs for improving bone mineral density or preventing hip fracture might have influenced the results. A decrease in the differences in nutrient intake levels might explain some of the change in regional differences in Japan.

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“…Exploratory research has shown general trends toward preference for less frequent dosing, although there is some variability in these findings depending on population, type of therapy, and the disease and symptoms being treated. 30,[45][46][47][48][49][50] Reducing the frequency of dosing has been shown to improve patient adherence to the treatment plan, 51 with no compromise on patient QOL. Thus, evaluating PNH patient preference for eculizumab and ravulizumab and their respective dosing frequencies is important for understanding and improving the PNH patient treatment experience.…”

Section: Discussionmentioning

confidence: 99%

“…Eleven patient preference questionnaires that most closely aligned with the objectives of this project were identified from the literature; [26][27][28][29][30][31][32][33][34][35][36] however, none of them evaluated patient preference and dosing schedules in a manner suitable for our aims. After reviewing the literature and the 11 questionnaires, the following concepts were identified as potentially relevant to our measure: symptom relief; effectiveness; ease of use/convenience/bother; impact on daily life; and medication preference.…”

Section: Literature Reviewmentioning

confidence: 99%

<p>Assessing Preferences for Rare Disease Treatment: Qualitative Development of the Paroxysmal Nocturnal Hemoglobinuria Patient Preference Questionnaire (PNH-PPQ©)</p>

Kaiser¹,

Yount²,

Martens³

et al. 2020

PPA

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Purpose: To develop a patient preference questionnaire (PPQ) assessing eculizumab and ravulizumab treatment for paroxysmal nocturnal hemoglobinuria (PNH). Patients and Methods: The development of the PNH-PPQ © was consistent with Food and Drug Administration guidelines for patient-reported outcome measure development, and included 1) a targeted literature review; 2) PNH expert clinician input on treatment preferences; 3) review of existing qualitative data on the PNH treatment and disease experience; 4) concept elicitation interviews with 8 PNH patients who received eculizumab and/or ravulizumab; 5) translatability review; and 6) cognitive debriefing with 5 patients. Interview participants were recruited through a United Kingdom PNH patient advocacy group and a Canadian clinical site involved in clinical trial ALXN1210-PNH-302. Results: Six themes were identified as most relevant to the PNH treatment experience from the concept elicitation interviews: disease symptoms (n=8/8); treatment frequency (n=7/8); quality of life impact of treatment/disease (n=7/8); treatment burden (n=7/8); treatment efficacy (n=5/8); and treatment side effects (n=5/8). An initial list of 88 preference questions was reduced to 11 highly relevant and non-redundant questions reflecting the 6 themes. Cognitive interview participants unanimously agreed that the PNH-PPQ instructions were clear; response options were understandable, easy to use, and provided enough choices; and the questions captured the factors that inform treatment preferences. Discussion: When new drugs have similar efficacy to existing medications, documenting patient preferences is important for confirming patient benefit from the new medication. Understanding what matters most to patients is essential for delivering patient-centered care and may play a particularly significant role in treatment decision making. The availability of such a tool may be especially important as new orphan drugs are developed and patients with rare diseases have more than one treatment option to consider. Conclusion: The PNH-PPQ provides a patient-centered approach for evaluating preferences for the treatment of PNH. The PNH-PPQ has subsequently assessed patient preference in the clinical trial sub-study ALXN1210-PNH-302s.

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Patient preference for monthly bisphosphonate versus weekly bisphosphonate in a cluster-randomized, open-label, crossover trial: Minodroate Alendronate/Risedronate Trial in Osteoporosis (MARTO)

Cited by 14 publications

References 19 publications

The Pharmacological Profile of a Novel Highly Potent Bisphosphonate, OX14 (1-Fluoro-2-(Imidazo-[1,2-α]Pyridin-3-yl)-Ethyl-Bisphosphonate)

The Pharmacological Profile of a Novel Highly Potent Bisphosphonate, OX14 (1-Fluoro-2-(Imidazo-[1,2-α]Pyridin-3-yl)-Ethyl-Bisphosphonate)

Hip fracture incidence in Japan: Estimates of new patients in 2012 and 25-year trends

<p>Assessing Preferences for Rare Disease Treatment: Qualitative Development of the Paroxysmal Nocturnal Hemoglobinuria Patient Preference Questionnaire (PNH-PPQ©)</p>

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