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Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis

NCT05387200 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-05-31

No results posted yet for this study

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 (alendronate 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.

Conditions

Interventions

DRUG

Masibone S

The investigators will evaluate the change of bone mineral density at lumbar spine measured by DEXA after 48 weeks of alendronate sodium trihydrate 70mg (oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily use.

DRUG

Fosamax

The investigators will evaluate the change of bone mineral density at lumbar spine measured by DEXA after 48 weeks of alendronate sodium 70mg (oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily use.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Yumie Rhee · Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387200 on ClinicalTrials.gov