Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® . (NCT04591275) | Clinical Trial Compass
CompletedPhase 3
Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .
China278 participantsStarted 2021-03-31
Plain-language summary
evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
Who can participate
Age range
50 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Fully informed, understood, voluntary participate, and the patient himself or guardian agree to sign the written informed consent and patient be able to comply with the protocol;
. Aged from 50 years to 85 years, inclusive;
. Spontaneous amenorrhea time ≥ 2 years, or bilateral oophorectomy≥ 2 years. If the status of bilateral ovariectomies is unknown, the menopause status should be confirmed by follicle stimulating hormone(FSH) level≥ 40IU/L;
. Based on the results of dual energy X-ray absorptiometry, BMD of lumbar spine(L1\~L4), femoral neck or total hip: -4.0\<T-Score≤-2.5；
. There must be at least one of the following risk factors:
. Ability to act independently.
Exclusion criteria
. Suffering from the following diseases known to affect calcium or bone metabolism:
. Medical history of two or more vertebrae fractures;
. Malignant tumor(excluding skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ or breast ductal carcinoma in situ) in recent 5 years;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
BMD percentage change from baseline at lumbar spine(L1~L4)