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Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk

2019-10-21 12:45:28 | BioPortfolio

Summary

A randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial to compare the efficacy and safety of QL1206 and placebo in postmenopausal women with osteoporosis at high risk of fracture

Description

This is a randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial.

The primary objective is to evaluate the effect of QL1206 treatment compared with placebo in Chinese postmenopausal women with osteoporosis at high risk of fracture.

The secondary objective is to evaluate the clinical safety, immunogenicity and pharmacokinetic (PK) characteristics of QL1206 in women with osteoporosis at high risk of postmenopausal fracture

The exploratory purpose is to evaluate the effect of ADA on the characteristics of QL1206 PK and the relationship between QL1206 exposure and pharmacodynamic endpoints, efficacy and adverse events

Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects would receive a single 60mg of QL1206 or placebo every 6 month for1 year(twice for one, subcutaneous injection) ,meanwhile taking 500 mg of calcium and 1000IU of vitamin D daily

Study Design

Conditions

Postmenopausal Osteoporosis

Intervention

QL1206, Placebos

Location

Shanghai sixth people's hospital
Shanghai
Shanghai
China

Status

Recruiting

Source

Qilu Pharmaceutical Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-21T12:45:28-0400

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