NCT07062978RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 14 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 278 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- 27 Jun 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Osteoporosis
- NCT number
- NCT07062978
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 278
- From 27 Jun 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 any of the following drugs within 6 weeks prior to screening that may affect bone metabolism.
Other illness
- Bone/metabolic disease.
- Thyroid condition: Hyperthyroidism or hypothyroidism.
- Malabsorption syndrome.
- Renal disease - severe impairment of kidney function.
- History of more than two vertebral fractures.
- Malignant tumors.
Other
- Hyperparathyroidism or hypoparathyroidism.
- Rheumatoid arthritis.
- Vitamin D defViciency (25-hydroxyvitamin D, 25OHD \<20 ng/mL).
- 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).
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Bijie Hospital Coordinator of this site? Confirm its status | Guizhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.