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The Deferasirox-calcium-vitamin D3 Therapy for Postmenopausal Osteoporosis (PMOP)

NCT02854722 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-05-17

No results posted yet for this study

Summary

In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for osteoporosis. Osteoporosis is a common complication in various diseases, such as hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all share iron accumulation as a common denominator. Moreover, a 3-year retrospective longitudinal study has shown that iron accumulation was also associated with osteoporosis in healthy adults and especially that it can increase the risk of fractures in postmenopausal women. Based on these observations, iron chelation therapy may have a promising future in the treatment of iron accumulation-related osteoporosis by removing iron from the body.

The purpose of this study is to determine whether the addition of the iron chelator, deferasirox, to standard therapy for postmenopausal osteoporosis, is safe and effective.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Deferasirox and calcium-vitamin D3

deferasirox and calcium-vitamin D3 Deferasirox is an orodispersible tablet and should be taken daily 30 minutes before breakfast, with a dose of 10 mg/Kg/day ± 5 mg/Kg/day during 12 month. Calcium 500 mg and vitamin D3 800 IU should also be taken daily as a basic therapy.

DRUG

Calcium-vitamin D3

Calcium 500 mg and vitamin D3 800 IU are taken daily as a basic therapy.

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • You-Jia Xu, Ph.D,M.D. · Second Afflilated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2019-06-15
Completion
2020-06-15

Countries

  • China

Study Locations

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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 NCT02854722 on ClinicalTrials.gov