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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
• Treatments: Calcium; Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Subject is willing to provide written informed consent.

2. Ambulatory woman between the age of 50 and 85 years, inclusive.

3. 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

4. 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

5. Postmenopausal defined as >2 years postmenopausal, which can be >2 years of spontaneous amenorrhea or >2 years post surgical bilateral oophorectomy.

Exclusion Criteria:

1. 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

2. Current hyperparathyroidism or hypoparathyroidism by medical record

3. Thyroid condition: Hyperthyroidism or hypothyroidism.

4. Rheumatoid arthritis

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