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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
Shanghai sixth people's hospital
Qilu Pharmaceutical Co., Ltd.
Published on BioPortfolio: 2019-10-21T12:45:28-0400
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Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.
A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.
Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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