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

NCT05387200 | Unknown Phase 4

• 1 other identifier: 4-2021-0486
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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 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

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of serum levels of bone turnover markers

  24 and 48 weeks

• Adherence to drug

  24 and 48 weeks

Study Arms (2)

Masibone S

EXPERIMENTAL

Masibone S (alendronate sodium trihydrate 70mg, oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks

Drug: Masibone S

Fosamax

ACTIVE COMPARATOR

Fosamax (aledronate sodium 70mg, oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks

Drug: Fosamax

Interventions

Masibone S DRUG

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.

Masibone S

Fosamax DRUG

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.

Fosamax

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Baek S, Ahn SH, Hong N, Seo DH, Hong S, Rhee Y. Efficacy and safety of weekly liquid alendronate in Korean postmenopausal women with osteoporosis: a 12-month, multi-center, randomized trial. Arch Osteoporos. 2024 Nov 26;19(1):119. doi: 10.1007/s11657-024-01480-6.

  PMID: 39589664 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Yumie Rhee

  Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yumie Rhee

CONTACT

+82-2-2228-0883; yumie@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: July 2, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)