Status:
UNKNOWN
Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
50-85 years
Phase:
PHASE3
Brief 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 r...
Detailed 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 Chine...
Eligibility Criteria
Inclusion
- 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 fracture（after 40 years）,parental history of hip fracture, low Body mass index (BMI≤19kg/m\^2), elderly (age≥65year)，current smoker
- Postmenopausal defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea or \>2 years post surgical bilateral oophorectomy.
Exclusion
- Bone/metabolic disease:a. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,which may interfere with the interpretation of the findings.
- b. Paget's disease c. Cushing's disease d. Hyperprolactinemia
- Current hyperparathyroidism or hypoparathyroidism by medical record
- Thyroid condition: Hyperthyroidism or hypothyroidism.
- Rheumatoid arthritis
- \-
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04128163
Start Date
June 5 2019
End Date
December 1 2021
Last Update
November 6 2019
Active Locations (1)
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1
Shanghai sixth people's hospital
Shanghai, Shanghai Municipality, China