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

May 13, 2018 updated by: You-Jia Xu, Second Affiliated Hospital of Soochow University

Phase 2 Study of Deferasirox-calcium-vitamin D3 to Treat Postmenopausal Osteoporosis (PMOP)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postmenopausal osteoporosis (PMOP) is a systemic bone metabolism disease, characterized by progressive bone loss following menopause and a subsequent increase in fracture risk. Estrogen deficiency as a result of menopause is known to increase bone resorption and accelerate bone loss. Furthermore, postmenopausal women may exhibit iron accumulation, in addition to estrogen deficiency. Elevated iron levels are a risk factor for PMOP in postmenopausal women, and reducing the iron overload by iron chelators has been demonstrated to benefit bone cell metabolism in vitro and improve the bone in vivo by normalizing osteoclastic bone resorption and formation.

Although the safety and efficacy of deferasirox have been evaluated in iron-overloaded patients extensively, there are no data in iron-accumulated postmenopausal women, let alone in iron-accumulated postmenopausal women with osteoporosis. Therefore, at the currently planned dose, confirming safety and efficacy is essential in the current study to lay the groundwork for a future phase III clinical trial.

This is a prospective, phase II, randomized, open label, placebo-controlled study of calcium-vitamin D3 plus deferasirox vs. calcium-vitamin D3 for postmenopausal osteoporosis. Ten postmenopausal women diagnosed with osteoporosis by DXA, who were accompanied by iron accumulation (serum 500ng/ml≤ferritin≤1000ng/ml), will be randomized to receive calcium-vitamin D3 plus deferasirox or calcium-vitamin D3 (n = 5 per arm).

The primary objective is to determine the safety and tolerability of adjunctive deferasirox therapy in postmenopausal women being treated with calcium-vitamin D3 for osteoporosis, and to obtain exploratory data on the efficacy of the iron chelation treatment. The reduction in iron levels with deferasirox may provide a viable therapeutic option for mitigating the iron accumulation associated with PMOP.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • Second Affiliated Hospital of Soochow University
        • Contact:
        • Principal Investigator:
          • You-Jia Xu, Ph.D,M.D.
        • Sub-Investigator:
          • Bin Chen, M.D.
        • Sub-Investigator:
          • Guang-fei Li, M.D.
        • Sub-Investigator:
          • Guang-si Shen, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Lumbar spine or hip BMD T-score ≤-2.5 SD.
  2. Elevated serum ferritin (females: serum 500ng/ml≤ferritin≤1000ng/ml).

Exclusion Criteria:

  1. Anemia < 10 g/dl
  2. Serum liver enzymes or bilirubin above the upper limit of normal at screening.
  3. Patients with creatinine clearance <60 ml/min will be excluded.
  4. Known allergy or contraindication to the administration of Deferasirox.
  5. History of blood transfusion during the 6 months prior to study entry.
  6. Oral iron supplementation within the last 4 weeks of study entry.
  7. Treatment with phlebotomy within 2 weeks of screening visit.
  8. Patient is already taking deferasirox therapy for any reason at the time of screening.
  9. Patients currently or previously treated with deferiprone or Deferasirox.
  10. Patients with active inflammatory diseases that may interfere with the accurate measurement of serum ferritin.
  11. Patients with a diagnosis of a clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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.
Placebo Comparator: Calcium-vitamin D3
Calcium 500 mg and Vitamin D3 800 IU are 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: 12 months

An adverse event was any untoward medical occurrence in participants, and did not necessarily need to have a causal relationship with the drug in the trial. The relationship of each adverse event to study drug or the severity of each adverse event was judged by the investigator, as described below. A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:

fatal or life-threatening; requires inpatient hospitalization; persistent or significant disability/incapacity;
12 months
Number of participants with abnormal blood pressure, heart rate, body temperature, and/or physical examination that are related to the treatment
Time Frame: 12 months
12 months
Bone mineral density
Time Frame: Baseline, Month 6, Month 12
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. Percent changes in DXA Bone Mineral Density from baseline to month 6 and month 12 of the trial in all patients. Percent change from Baseline was calculated as (BMD at Month 6 or Month 12 - BMD at Baseline)/BMD at Baseline * 100%.
Baseline, Month 6, Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in serum C-terminal telopeptide of type I collagen (β-CTX)
Time Frame: Baseline, Month 3, Month 6, Month 9 and Month 12
Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in serum N-aminoterminal prepeptide of type I procollagen (P1NP)
Time Frame: Baseline, Month 3, Month 6, Month 9 and Month 12
Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in serum ferritin
Time Frame: Baseline, Month 3, Month 6, Month 9 and Month 12
Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in blood chemistry
Time Frame: Baseline, Week 2, Week 4 and Month 3, Month 6, Month 9, Month 12 of the trial
Baseline, Week 2, Week 4 and Month 3, Month 6, Month 9, Month 12 of the trial
Change from baseline in hematology
Time Frame: Baseline, Week 2, Week 4 and Month 3, Month 6, Month 9, Month 12 of the trial
Baseline, Week 2, Week 4 and Month 3, Month 6, Month 9, Month 12 of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Anticipated)

June 15, 2019

Study Completion (Anticipated)

June 15, 2020

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 30, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 13, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL2014044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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