Trial intelligence / Profile preview

Masibone S vs Fosamax in Postmenopausal Osteoporosis

NCT05387200Phase 4

Key facts

Status: Unknown
Start: Jul 2021
Primary completion: May 2023
Countries: 1
Sponsor: Yonsei University
Modality: Small Molecules

Drugs: alendronate
Conditions: postmenopausal osteoporosis

Overview

Phase 4, randomised, open-label trial of alendronate in postmenopausal osteoporosis (2 arms), sponsored by Yonsei University. Primary endpoint: Change of bone mineral density at lumbar spine at 48 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Masibone S
Masibone S (alendronate sodium trihydrate 70mg, oral solution) 1 bottle weekly
Fosamax
Fosamax (alendronate sodium 70mg, oral tablet) 1 tablet weekly

Endpoints

Primary

Change of bone mineral density at lumbar spine48 weeks

Secondary

Change of serum levels of bone turnover markers48 weeks
Adherence to drug48 weeks

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