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Can a biosimilar match prolia in strengthening bones?

NCT ID NCT06804590

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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