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Tests treatment safety and results for Postmenopausal Women Osteoporosis
Official title A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis
ClinicalTrials.gov ID: NCT06804590
What this study is testing
What is 9MW0311?
9MW0311 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for postmenopausal women osteoporosis.
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-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for 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 80, women only
You may be able to join if
- Women who can walk freely (≥50 and ≤80 years);
- As measured by DXA, the absolute value of BMD at lumbar spine, femoral neck or total hip was -4.0\<T value ≤-2.5;
- people must have at least one of the following other risk factors: 1) history of previous fragility fractures; 2) Either or both parents have a...
- 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
- Malignant tumors
- Malabsorption syndrome
See the full eligibility criteria
- Women who can walk freely (≥50 and ≤80 years);
- As measured by DXA, the absolute value of BMD at lumbar spine, femoral neck or total hip was -4.0\<T value ≤-2.5;
- people must have at least one of the following other risk factors: 1) history of previous fragility fractures; 2) Either or both parents have a history of hip fragility fracture; 3) Increased bone turnover rate during...
- 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
- Malignant tumors
- Malabsorption syndrome
- Liver cirrhosis, active hepatitis B or hepatitis C, and unstable liver disease; serum aspartate aminotransferase and alanine aminotransferase ≥ 2.0 times the upper limit of normal (ULN); alkaline phosphatase or total...
- Renal disease - severe impairment of kidney function
- Clinically significant cardiovascular and cerebrovascular diseases (such as myocardial infarction, unstable angina or stroke, NYHA class III or IV heart failure in the 12 months prior to screening) and hematopoietic...
- Hypercalcemia or hypocalcemia ;
- vitamin D deficiency (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...
- Use of intravenous bisphosphonates within the previous 2 years;
- oral bisphosphonates (used for at least 2 years, or used for less than 2 years but more than 3 months, with the last use occurring \<1 year before the screening);
- Use of any of the following drugs within 6 weeks prior to screening that may affect bone metabolism:
- parathyroid hormone (PTH) or PTH derivatives, such as teriparatide;
- anabolic hormones or testosterone;
- glucocorticoids (equivalent dose more than 5mg/ day of prednisone and continuous use for more than 10 days);
- Selective estrogen receptor modulators (SERMs), such as raloxifene;
- Menopausal hormone therapy (such as estrogen, estrogen + progesterone, tibolone);
- Active vitamin D and its analogues (cumulative use of more than 30 days);
- Other bone-active drugs include antiepileptic drugs (except benzodiazepines) and heparin;
- Long-term systemic use of ketoconazole, adrenocorticotropin (ACTH), aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonists;
- Chinese patent medicines for osteoporosis related treatment are clearly described in the instructions, such as Xianling Gubao capsule (tablet), Gushukang capsule (granule), Jintiange capsule and Qianggu capsule."
- History of more than two vertebral fractures.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.