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Tests treatment safety and results for Postmenopausal Women With Osteoporosis at High Risk of...
Official title A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
ClinicalTrials.gov ID: NCT07062978
What this study is testing
What is QL1206?
QL1206 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for postmenopausal women with osteoporosis at high risk of fracture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85, women only
You may be able to join if
- people 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).
- people whose absolute value of bone mineral density (BMD) in the lumbar or total hip area meets T values ≤ -2.5 and \> -4.0.
- people who must have at least one of the following risk factors: History of previous fragility fractures (occurring after the age of 40); history of...
- The duration of spontaneous amenorrhea was \>2 years or \>2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or...
You likely can't join if
- Bone/metabolic disease.
- Hyperparathyroidism or hypoparathyroidism.
- Thyroid condition: Hyperthyroidism or hypothyroidism.
- Rheumatoid arthritis.
- Malabsorption syndrome.
- Renal disease - severe impairment of kidney function.
See the full eligibility criteria
- people 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).
- people whose absolute value of bone mineral density (BMD) in the lumbar or total hip area meets T values ≤ -2.5 and \> -4.0.
- people 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guizhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guizhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.