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

  • STATUS
    Recruiting
  • days left to enroll
    76
  • participants needed
    440
  • sponsor
    Qilu Pharmaceutical Co., Ltd.
Updated on 23 January 2021
body mass index
calcium
vitamin d
oophorectomy
osteoporosis
hip fracture

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

Details
Condition Osteoporosis, Postmenopausal osteoporosis, Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
Treatment placebos, QL1206
Clinical Study IdentifierNCT04128163
SponsorQilu Pharmaceutical Co., Ltd.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is willing to provide written informed consent
Ambulatory woman between the age of 50 and 85 years, inclusive
The subject has a BMD absolute value consistent with a T-score<-2.5 and >-4.0 at either the lumbar spine or total hip
All subjects must have at least one of following additional the risk factors:history of fractureafter 40 years,parental history of hip fracture, low Body mass index (BMI19kg/m^2), elderly (age65year)current smoker
Postmenopausal defined as >2 years postmenopausal, which can be >2 years of spontaneous amenorrhea or >2 years post surgical bilateral oophorectomy

Exclusion Criteria

Bone/metabolic disease:a. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,which may interfere with the interpretation of the findings
Paget's disease c. Cushing's disease d. Hyperprolactinemia
Current hyperparathyroidism or hypoparathyroidism by medical record
Thyroid condition: Hyperthyroidism or hypothyroidism
Rheumatoid arthritis
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