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

• Status: Unknown status
• Trial end date: 2020-06-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Second Affiliated Hospital of Soochow University
• Treatments: Calcium; Calcium, Dietary; Cholecalciferol; Deferasirox; Ergocalciferols; Vitamin D; Vitamins

Criteria

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.