Delving into the Latest Updates on Alendronate/Calcitriol with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Maxmarvil

Target

VDR

Action

antagonists, inhibitors

Mechanism

VDR antagonists(Vitamin D receptor antagonists), Osteoclasts inhibitors

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal Diseases

Active Indication

Osteoporosis

Inactive Indication

Fractures, Bone

Originator Organization

Yuyu Pharma, Inc.

Active Organization

Yuyu Pharma, Inc.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

South Korea (01 Oct 2004),

Osteoporosis

Regulation-

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Structure/Sequence

Molecular FormulaC31H57NO10P2

InChIKeyBNJDRERROFIUJH-RFHBVEJWSA-N

CAS Registry852317-24-9

BACKGROUNDBisphosphonate (BP) is an effective drug for the prevention and treatment of osteoporosis. However, gastrointestinal distress caused by BP is a well-known side effect for low compliance. The aim of our study was to compare the 1-year persistence, compliance and T-scores between the aperitif medication group and the postprandial medication group.METHODSThree hundred patients were included in this study to determine their persistence and compliance with the prescribed daily BP (Maxmarvil®, alendronate 5 mg and calcitriol 0.5 µg; YuYu Pharm) following distal radius fractures. Patients in Group 1 (aperitif medication) were asked to adhere to the general guidelines for BPs before breakfast. Patients in Group 2 (postprandial medication) were recommended medication after breakfast. We compared the persistence and compliance of this daily BP therapy using the medication possession ratio (MPR) and T-scores between the 2 groups after 1 year.RESULTSBone mineral density in hip and lumbar spine was improved significantly in 2 groups (P<0.001). Significant differences existed between 2 groups, including 73 of 150 patients (48.7%) in Group 1, and 111 of 150 patients (73.3%) in Group 2 for 1-year persistence (P=0.001). The mean MPR is 0.66 in Group 1 (range, 0.50-0.86) and 0.71 in Group 2 (range, 0.54-0.87). A significant difference was detected between the 2 groups (P=0.002).CONCLUSIONSPostprandial administration improved persistence and compliance with daily BP therapy, resulting in better clinical outcomes.

01 Jan 2017·Journal of Bone Metabolism

Fracture Preventing Effects of Maxmarvil® Tablets (Alendronate 5 mg + Calcitriol 0.5 µg) in Patients with Osteoporosis

Article

Author: Kim, Dong-Soo ; Kim, Sang-Bum ; Yoo, Jun-Il ; Won, Ye-Yeon ; Ha, Yong-Chan ; Yoo, Ju-Hyung ; Yang, Kyu-Hyun

BACKGROUNDThe purpose of this prospective, open-label, observational study was to assess the fracture preventing effect of Maxmarvil® tablets (alendronate 5 mg + calcitriol 0.5 µg) in patients with osteoporosis and to evaluate the change in bone mineral density (BMD) at the minimum 1-year follow-up.METHODSIn this multicenter observational study, 691 patients with osteoporosis (aged 50 years or older) were treated with alendronate 5 mg + calcitriol 0.5 µg/day during their normal course of care. Patients were assessed at baseline and at 6 and 12 months. Baseline characteristics (including age, gender, concomitant disease, and baseline fractures) were evaluated.RESULTSFrom among the 848 participants, 149 individuals were lost to follow-up at the time of the study and 8 people had died. The 691 participants (54 men and 637 women) finished the follow-up study and completed the questionnaire. The mean age of the participants was 71.5 years (range, 50-92 years; mean age, 72.3 years for men and 71.4 years for women). Osteoporotic fracture occurred in 19 patients (2.7%). BMD of the lumbar spine and hip was improved by 5% and 1.5% at the latest follow-up. At the latest follow-up, 24 patients (3.5%) complained of drug-related complications such as dyspepsia, constipation, and nausea.CONCLUSIONSThis prospective observational study demonstrated that alendronate 5 mg + calcitriol 0.5 µg/day had a preventive effect on osteoporotic fracture and it increased the BMD of the lumbar spine by 5% at the latest follow-up.

01 Jan 2017·Journal of Menopausal Medicine

Combination Therapy of Raloxifene and Alendronate for Treatment of Osteoporosis in Elderly Women

Article

Author: Jung, Hyuk ; Um, Mi Jung ; Cho, Eun A

OBJECTIVESTo evaluate and compare the efficacy and safety of the combination of raloxifene and alendronate with those of monotherapies in elderly women with osteoporosis.METHODSSixty-two postmenopausal women (mean age 63.5 ± 0.5 years) attending gynecologic osteoporosis clinics with established osteoporosis were randomly allocated to one of four treatment groups and monitored for 3 years. All patients enrolled in this study, including those in the control group (n = 14), received 1.0 g elemental calcium and 400 units of vitamin D per day. The raloxifene group (n = 16) received raloxifene 60 mg (Evista®) per day; alendronate group (n = 17) received low-dose (5 mg) alendronate with calcitriol 0.5 µg (Maxmarvil®) per day; and the combination therapy group (n = 15) received both raloxifene 60 mg and low-dose (5 mg) alendronate with calcitriol 0.5 µg. Bone mineral density (BMD) was measured in the lumbar spine and hip before and after 3 years of treatment.RESULTSIn patients who received the combined therapy, BMD increased in the lumbar spine and the hip by 7.2% (P<0.001) and 4.8% (P<0.001) at 3 years. For patients in the alendronate group, the increases were 6.7% (P<0.001) and 3.1% (P<0.01) respectively, for the raloxifene group, the increases were 4.36% (P<0.001) and 1.9% (P<0.05) in the vertebrae and femora, respectively; however, the BMD of patients in the control group decreased by 1.81% (P<0.05) and 1.6% (P<0.05), respectively, after 3 years. Patients who received the combination therapy had significantly higher BMD in both the vertebrae femora (P<0.01) in comparison to that in those treated with raloxifene or alendronate individually.CONCLUSIONSThis 3-year randomized study showed the improved effects of alendronate and raloxifene combination on spine and hip BMD in elderly postmenopausal women with established osteoporosis.

100 Deals associated with Alendronate/Calcitriol

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