Postmenopausal Osteoporosis Clinical Trial
Official title:
A Twelve-month Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of QL1206 in Chinese Postmenopausal Women With Osteoporosis at High Risk of Fracture
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
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
;
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