Actively Recruiting
A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-07-14
278
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind comparative study to valuating the efficacy and safety of QL1206 and Prolia® in postmenopausal women with osteoporosis at high risk of fracture.
CONDITIONS
Official Title
A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to participate and sign informed consent
- Postmenopausal women aged 50 to 85 years who can walk freely
- Bone mineral density T-score in lumbar or total hip area between -2.5 and -4.0
- At least one fracture risk factor: previous fragility fractures after age 40, parental history of hip fractures, increased bone turnover, low body weight (BMI 60 19), age 65 or older, or current smoker
- Spontaneous amenorrhea for more than 2 years or more than 2 years after bilateral oophorectomy, or FSH level above 40 mIU/mL if menopausal status uncertain
You will not qualify if you...
- Presence of bone or metabolic diseases
- Hyperparathyroidism or hypoparathyroidism
- Hyperthyroidism or hypothyroidism
- Rheumatoid arthritis
- Malabsorption syndrome
- Severe kidney impairment
- Vitamin D deficiency (25OHD less than 20 ng/mL)
- Oral or dental diseases including mandibular osteomyelitis or osteonecrosis, acute dental disease needing surgery, planned invasive dental surgery, or incomplete recovery from dental surgery
- Previous use of denosumab
- Use of intravenous bisphosphonates, fluoride, or strontium for osteoporosis in the last 5 years
- Oral bisphosphonates use for at least 3 years or use less than 3 years but more than 3 months with last use under 1 year before consent
- Use of drugs affecting bone metabolism within 6 weeks prior to screening
- History of more than two vertebral fractures
- Malignant tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital Bijie Hospital
Guizhou, China
Actively Recruiting
Research Team
Y
Youjia Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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