A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
Recruiting · NCT07062978 · Interventional (participants receive a specific treatment) · Lead sponsor: Qilu Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Prolia®QL1206
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.
Who can take part
Age range
50 Years to 85 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Zhejiang Provincial People's Hospital Bijie Hospital - Guizhou, China