Status:
UNKNOWN
Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis
Lead Sponsor:
Yonsei University
Conditions:
Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
Brief Summary
This study aims to prove non-inferiority of the efficacy of Masibone S (alendronate sodium trihydrate 70mg, oral solution) on the treatment of postmenopausal osteoporosis compared to the efficacy of F...
Eligibility Criteria
Inclusion
- postmenopausal women ≥50 years old
- osteoporosis - BMD T-score ≤-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks
- \- BMD T-score -1.0\~-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks and history of osteoporotic fractures - BMD T-score -1.0\~-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks and FRAX MOF \>20% or HF \>3%
- Those who voluntarily agree in written form to participate in the clinical trial after hearing the explanation of this clinical trial and those who do not have any of exclusion criteria
Exclusion
- Patient with history of drugs that affect bone mineral density - bisphosphonate, denosumab, teriparatide, romosozumab within one year - calcitonin or analogues, calcimimetics within previous 12 weeks - strontium or fluoride for treating osteoporosis at any time in the past
- Patients with history of osteonecrosis of jaw, osteonecrosis of external ear canal, or atypical femoral fracture
- Patients with history of invasive dental procedure (tooth extraction, implant, oral surgery etc) within previous 24 weeks or patients who plan for invasive dental procedure during the clinical trial period
- Patients with risk of aspiration (esophageal disorders such as esophageal stricture, achalasia or patients who can not sit or stand for more than 30 minutes)
- Patients with severe renal dysfunction (eGFR by MDRD \<30 ml/min/1.73m2 or on dialysis) or liver dysfunction (AST or ALT ≥x3 upper limit of normal reference range)
- Patients who are under treatment or plan for treatment due to solid tumor or hematologic malignancy
- Patients with secondary osteoporosis (persistent systemic steroid use, uncontrolled hyperthyroidism, primary hyperparathyroidism)
- Hypocalcemia (albumin-corrected calcium \<2.1mmol/L) or vitamin D deficiency (25OHD \<10ng/mL) during screening
- Patients with known allergic reaction, hypersensitivity, or intolerance to bisphosphonate and other components of intervention drugs during screening (including latex allergy and hereditary fructose intolerance)
- Patients who the examiner considers not eligible for clinical trials
Key Trial Info
Start Date :
July 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05387200
Start Date
July 2 2021
End Date
May 1 2023
Last Update
May 31 2022
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea