Overview

A Multi Center, Randomized, Open-label, Parallel, Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis

Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
Female
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 Fosamax (aledronate sodium 70mg, oral tablet). The effect of Masibone S and Fosamax on bone mineral density in postmenopausal women with osteoporosis will be compared and analyzed. This study included a total 170 patients (85 per subgroup) for multi-center, randomized, open-label, parallel clinical trial. The drugs will be maintained for a total of 48 weeks. The primary endpoint is the difference of bone mineral density change at lumbar spine measured by DEXA between two groups.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yonsei University
Treatments:
Alendronate
Criteria
Inclusion Criteria:

1) postmenopausal women ≥50 years old 2) 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 lumbr spine,
femoral neck, or total hip within previous 24 weeks and history of osteoporotic fractures -
BMD T-score -1.0~-2.5 at lumbr spine, femoral neck, or total hip within previous 24 weeks
and FRAX MOF >20% or HF >3% 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 Criteria:

1) Patient with history of drugs that affect bone mineral density - bisphosphonate,
denosumab, teriparatide, romosozumab whithin one year - calcitonin or analogues,
calcimimmetics within previous 12 weeks - strontium or fluoride for treating osteoporosis
at any time in the past 2) Patients with history of osteonecrosis of jaw, osteonecrosis of
external ear canal, or atypical femoral fracture 3) 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 4)
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) 5) 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) 6) Patients who are
under treatement or plan for treament due to solid tumor or hematologic malignancy 7)
Patients with secondary osteoporosis (persistent systemic steroid use, uncontrolled
hyperthyroidism, primary hyperparathyroidism) 8) Hypocalcemia (albumin-corrected caclium
<2.1mmol/L) or vitamin D deficiency (25OHD <10ng/mL) during screening 9) Patients with
known allergic reation, hypersensitivity, or intolerance to bisphosphonate and other
components of intervention drugs during screening (including latex allergy and hereditary
fructose intolerance) 10) Patients who the examiner considers not eligible for clinical
trials