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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Masibone S; Drug: Fosamax

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yumie Rhee; Phone Number: +82-2-2228-0883; Email: yumie@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Yumie Rhee; Phone Number: +82-2-2228-0883; Email: yumie@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 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%

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 within one year - calcitonin or analogues, calcimimetics 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 treatment or plan for treatment due to solid tumor or hematologic malignancy
7. Patients with secondary osteoporosis (persistent systemic steroid use, uncontrolled hyperthyroidism, primary hyperparathyroidism)
8. Hypocalcemia (albumin-corrected calcium <2.1mmol/L) or vitamin D deficiency (25OHD <10ng/mL) during screening
9. 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)
10. Patients who the examiner considers not eligible for clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Masibone S; Masibone S (alendronate sodium trihydrate 70mg, oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks	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.
ACTIVE_COMPARATOR: Fosamax; Fosamax (aledronate sodium 70mg, oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of bone mineral density at lumbar spine	DEXA is used to evaluate the change of bone mineral density at lumbar spine after 48 weeks of drug intervention compared to those at baseline	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of serum levels of bone turnover markers	Serum levels bone turnover markers (CTX and P1NP) is measured at baseline and after 24 and 48 weeks of drug intervention and the change of serum levels of CTX and P1NP is evaluated.	24 and 48 weeks
Adherence to drug	The proportion of patients who compliantly uses drugs after 24 and 48 weeks of intervention will be evaluated.	24 and 48 weeks

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Yumie Rhee, Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (ACTUAL): May 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: 4-2021-0486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No