Trial intelligence / Profile preview

Deferasirox in postmenopausal osteoporosis

NCT02854722Phase 2

Key facts

Status: Unknown
Start: Jan 2018
Primary completion: Jun 2019
Countries: 1
Sponsor: The Second Affiliated Hospital of Soochow University
Modality: Small Molecules

Drugs: deferasirox
Conditions: postmenopausal osteoporosis

Overview

Phase 2, randomised, open-label trial of deferasirox in postmenopausal osteoporosis (2 arms), sponsored by The Second Affiliated Hospital of Soochow University. Primary endpoints: Number of participants with adverse events at 12 months, Number of participants with abnormal blood pressure, heart rate, body temperature, and/or physical examination related to treatment at 12 months and 1 more. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Deferasirox + Calcium-Vitamin D3
Experimental arm receiving iron chelation plus standard therapy.
Calcium-Vitamin D3
Control arm receiving standard therapy only.

Who it enrols

Postmenopausal women with a BMD T-score ≤ -2.5 and elevated serum ferritin (500-1000 ng/ml), excluding those with anemia, liver dysfunction, or renal impairment.

Endpoints

Primary

Number of participants with adverse events12 months
Number of participants with abnormal blood pressure, heart rate, body temperature, and/or physical examination related to treatment12 months
Bone mineral densityMonth 12

Secondary

Serum C-terminal telopeptide of type I collagenMonth 12
Serum N-aminoterminal prepeptide of type I procollagenMonth 12
Serum ferritinMonth 12
Blood chemistryMonth 12
HematologyMonth 12

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