RECRUITINGPhase 3INTERVENTIONAL
A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Subjects who agree to participate in the study and sign the willing to sign a consent form 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.
Who Should NOT Join This Trial:
- 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
QL1206
QL1206 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
DRUG
Prolia®
Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
Locations (1)
Zhejiang Provincial People's Hospital Bijie Hospital
Guizhou, China