💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Subjects who agree to participate in the study and sign the informed consent form.
* Postmenopausal women who can walk freely, aged 50-85 years (including 50 and 85 years old).
* Subjects whose absolute value of bone mineral density (BMD) in the lumbar or total hip area meets T values ≤ -2.5 and \> -4.0.
* Subjects who must have at least one of the following risk factors: History of previous fragility fractures (occurring after the age of 40); history of hip fractures in fathers or mothers; increased bone turnover rate during screening; low body weight (BMI ≤ 19 kg/m2); advanced age (aged ≥ 65 years); current smoke.
* The duration of spontaneous amenorrhea was \>2 years or \>2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or if the ovaries are preserved after hysterectomy, follicle stimulating hormone (FSH) levels \>40mIU/mL may be used to confirm the status of postoperative menopause.
Exclusion Criteria:
* Bone/metabolic disease.
* Hyperparathyroidism or hypoparathyroidism.
* Thyroid condition: Hyperthyroidism or hypothyroidism.
* Rheumatoid arthritis.
* Malabsorption syndrome.
* Renal disease - severe impairment of kidney function.
* Vitamin D defViciency (25-hydroxyvitamin D, 25OHD \<20 ng/mL).
* Oral or dental diseases: previous or current evidence of mandibular osteomyelitis or osteonecrosis; Acute dental or mandibular disease requiring oral surgery; Planning invasive dental surgery; Failure to recover from dental or oral surgery.
* Previously used denosumab drugs.
* Use of intravenous bisphosphonates, fluoride, or strontium to treat osteoporosis within the last 5 years.
* OOral bisphosphonates (used for at least 3 years, or used for less than 3 years but more than 3 months, with the last use occurring \<1 year before the ICF).
* Use of any of the following drugs within 6 weeks prior to screening that may affect bone metabolism.
* History of more than two vertebral fractures.
* Malignant tumors.
Zhejiang Provincial People's Hospital Bijie Hospital
Guizhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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