Can a biosimilar match prolia in strengthening bones?
NCT ID NCT06804590
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial tests whether an experimental biosimilar called 9MW0311 works as well as the established drug Prolia (both containing denosumab) in postmenopausal women with osteoporosis who are at high risk for fractures. Participants receive either 9MW0311 or Prolia as an injection every six months for a year. The study measures changes in bone density and monitors safety and immune response to see if the biosimilar is a viable alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- denosumab (biosimilar 9MW0311) compared with Prolia (denosumab)
- What this could lead to
- If successful, this could provide a more affordable, equally effective option for treating osteoporosis and reducing fracture risk in postmenopausal women.
- What could go wrong
- This is a phase III trial, but results may not match Prolia exactly, and long-term safety or immunogenicity differences could emerge. The study is limited to a specific population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
280 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 80 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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; * Subjects 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 screening; 4) Low body weight; 5) Old age(≥70); 6) Currently smoking. * 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 * 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 bilirubin ≥ 1.5 ULN; * 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 system disease judged by the investigator; * 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 dental or oral surgery; * 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: 1. parathyroid hormone (PTH) or PTH derivatives, such as teriparatide; 2. anabolic hormones or testosterone; 3. glucocorticoids (equivalent dose more than 5mg/ day of prednisone and continuous use for more than 10 days); 4. Selective estrogen receptor modulators (SERMs), such as raloxifene; 5. Menopausal hormone therapy (such as estrogen, estrogen + progesterone, tibolone); 6. Active vitamin D and its analogues (cumulative use of more than 30 days); 7. Other bone-active drugs include antiepileptic drugs (except benzodiazepines) and heparin; 8. Long-term systemic use of ketoconazole, adrenocorticotropin (ACTH), aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonists; 9. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Postmenopausal women osteoporosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mabwell (Shanghai) Bioscience Co., Ltd.
Beijing, China