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Postmenopausal OsteoporosisPhase 3NCT04591275

Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

A Phase 3 study testing CMAB807 Injection and Prolia® in people with Postmenopausal Osteoporosis, run by Shanghai Biomabs Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product) Read more about this study

Who is it for?
Ages 50 to 85 years, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
CMAB807 Injection and Prolia®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
278 participants
Where
1 siteChina
Study dates
31 Mar 2021to 1 Nov 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • History of osteoporotic fracture;
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  • Father's and mother's hip fracture history, or both parents';
  • Low body mass index(≤19kg/m^2);
  • Patient's age was equal or greater than 70 years old;
  • Current smoker;
  • CTX1 was one standard deviation higher than that of healthy premenopausal women within screening period(ie, CTX1>0.43ng/mL);
  • Ability to act independently.

Who cannot join

  • Suffering from the following diseases known to affect calcium or bone metabolism:
  • Various metabolic bone diseases, such as osteogenesis imperfecta and osteomalacia;
  • Paget's osteopathy;
  • Cushing's syndrome;
  • Hyperprolactinemia;
  • Hypopituitarism;
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  • Acromegaly;
  • History of hyperparathyroidism or hypoparathyroidism;
  • History of hyperthyroidism or hypothyroidism(hypothyroidism patients can be included: only receiving stable thyroid hormone replacement therapy, if the thyroid stimulating hormone(TSH) level is normal, or 5.5μIU/mL<TSH≤10.0μIU/mL, and free thyroxine(FT4) is in normal range can be included);
  • Malabsorption syndrome or various gastrointestinal diseases associated with malabsorption, such as Crohn's disease and chronic pancreatitis;
  • Abnormal level of blood calcium: the current diagnosis of hypocalcemia or hypercalcemia or albumin corrected serum calcium levels are not within the laboratory normal range(calcium supplements should not be used for at least 8 hours prior to serum calcium testing);
  • Vitamin D deficiency: 25 hydroxyvitamin D concentration<20ng/mL. Allowed to retest after oral vitamin D2 soft capsules in the screening period. If the concentration of 25 hydroxyvitamin D is more than or equal to 20ng/mL， it can be selected;
  • Other diseases such as rheumatoid arthritis, gout, multiple myeloma, etc;
  • 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;
  • Severe renal function damage(creatinine clearance rate<30mL/min), or dialysis, urinary calculi or chronic cystitis;
  • Suffering from the following liver or biliary diseases:
  • Liver cirrhosis;
  • Biliary abnormalities(except for Gilbert syndrome or asymptomatic gallstones);
  • Positive hepatitis C virus antibody(HCV-Ab) and the titer of HCV-RNA exceeded the upper limit of norma;
  • Positive hepatitis B suface antigen(HBsAg) and peripheral blood HBV-DNA titer ≥1000 capies[CPS]/mL or 200IU/mL;
  • Unstable liver disease: defined as liver ascites, hepatic encephalopathy, coagulopathy, hypoalbuminemia, varicosis in esophagus or stomach fundus or persistent hepatic jaundice;
  • Liver transaminase: aspartate aminotransferase≥2.0×upper limit of norma value(ULN), alanine aminotransferase≥2.0ULN, alkaline phosphatase≥1.5ULN or total bilirubin≥1.5ULN;
  • Suffering from the following oral diseases:
  • Osteomyelitis or osteonecrosis of the jaw, previously or currently;
  • Actue dental or mandibular disease requiring stomatological surgery;
  • Planned invasive dental surgery during the trial period;
  • Dental or stomatological surgery have not healed;
  • Conditions which can influence bone mineral density determination by dual energy X-ray absorptiometry:
  • Less than two lumbar vertebrae can be measured;
  • Height, weight or waistline may hinder accurate measurement;
  • Other conditions that may affect bone density testing
  • Received anti-osteoporosis drugs or those drugs may affect bone metabolism:
  • Use of injectable bisphosphonates, fluoride or strontium within 2 years before screening;
  • Use of oral bisphosphonates: more than 2 years, or more than 3 months but less than 2 years and discontinued from last dosage less than 1 year, simultaneously;
  • Usage of any drugs which may affect bone metabolism within 6 weeks before screening: parathyroid hormone or parathyroid hormone analogue(such as teriparatide); assimilative hormone or testosterone; glucocorticoid(equivalent to prednisone>5mg/day for more than 10 days); systemic hormone replacement therapy; selective estrogen receptor regulator(such as reloxifene); tibolone; calcitonin; active vitamin D and ite analogues, other bone active drugs include anticonvulsant drugs(except benzodiazepines) and he[arin; long-term systemic use of ketoconazole, androgen, adrenocorticotropic hormone, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonist;
  • Patients who have received RANKL inhibitors previously;
  • Positive HIV antibody;
  • Known alcoholism or drug abuse(during 12 months before screening), because alcohol or drug abuse may interfere with subject's understanding or finish of trial;
  • Known allergy to test drug, reference drug or basic drug and its excipients;
  • Participate in interventionary clinical study(drug or device) within one month before screening;
  • Other serious, acute or chronic diseases, mental disorders or laboratory abnormalities, which are judged by investigator to be unsuitable to participate this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hosptial

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: Randomized, Doubel-blinded, Parallel, Active-controlled Phase III Study, to Evaluate the Efficacy and Safety of CMAB807 Treatment Compared with Prolia® in Chinese Postmenopausal Women with Osteoporosis At High Risk of Fracture.

evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)

Read the detailed description

this is a randomized, double-blinded, parallel, active-controlled clinical phase III study. the primary objective is to evaluate the efficacy and safety of CMAB807 treatment compared with Prolia in Chinese postmenopausal women with osteoporosis at high risk of fracture.

Subjects should sequentially enrolled according to the protocol in one of two arms. Subjects who entered in test arm would receive 60mg of CMAB807 subcutaneously every 6 months for one year, while those who entered in control arm should receive 60mg of Prolia subcutaneously every 6 months for one year. Meanwhile, every subject should taking 600mg calcium and 400IU vitamin D daily from successfully screening to the end of study.

Being tested
CMAB807 Injection, Prolia®
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMAB807 InjectionDrug

    Also called Denosumab Injection

    mAb targeting RANKL, human monoclonal antibody targeting RANKL

  • Prolia®Drug

    Also called Denosumab Injection

    mAb targeting RANKL, human monoclonal antibody targeting RANKL

Study groups in NCT04591275
Study groupRoleWhat they receive
CMAB807Experimental60mg, every 6 months, subcutaneously for twice. dietary supplement: elemental calcium orally, 600mg, daily, and vitamin D orally, 400IU, daily
Receives: Drug: CMAB807 Injection
Prolia®Active comparator60mg, every 6 months, subcutaneously for twice. dietary supplement: elemental calcium orally, 600mg, daily, and vitamin D orally, 400IU, daily
Receives: Drug: Prolia®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMD percentage change from baseline at lumbar spine(L1~L4)

    Percentage change from baseline at lumbar spine(L1~L4) by dual-energy X-ray absorptiometry to month 12 of treatment and compare between two arms. Percentage change of lumbar spine BMD from baseline to at month 12 of treatment=(BMD at month 12 of treatment - BMD at baseline)/BMD at baseline*100%

    Measured: baseline, at 12 months

Secondary outcomes (7)

  1. BMD percentage change from baseline at lumbar spine(L1~L4)

    Percentage change from baseline at lumbar spine(L1~L4) by dual-energy X-ray absorptiometry to month 6 of treatment and compare between two arms. Percentage change of lumbar spine BMD from baseline to at month 12 of treatment=(BMD at month 12 of treatment - BMD at baseline)/BMD at baseline*100%

    Measured: baseline, at 6 months

  2. BMD percentage change from baseline at total hip, trochanter and femoral neck

    Pencentage change from baseline at total hip, trochanter and fremoral neck by dual-energy-X-ray absorptiometry to month 6 and month 12 of treatment, and compare between two arms. Percentage to total hip, trochanter and femoral neck BMD from baseline at month 6 or month 12 of treatment=(BMD at month 6 or month 12 of treatment - BMD at baseline)/BMD at baseline*100%

    Measured: baseline, at month 6, at month 12

  3. Serum CTX1 and P1NP concentration percentage change from baseline

    Fasting serum CTX1 and P1NP samples should be collected. Percentage changes of serum CTX1 or P1NP concentrations from baseline at month 1, month 3, month 6, month 9 and at month 12 of treatment=(serum concentrations at month 1, month 3, month 6, month 9 and month 12 - serum concentration at baseline)/serum concentration at baseline*100%

    Measured: baseline, at month 1, at month 3, at month 6, at month 9,and at month 12

  4. Proporation of new osteoporotic fractures(vertebrae, total hip and non-vertebrae) occurring within the study period

    Osteoporotic fracture is defined as the fracture occurred when subject suffers minor trauma or during daily activities. Common occurrence sites are vertebral body, hip, distal forearm, proximal humerus and pelvis, etc

    Measured: baseline, at month 12

  5. Adeverse events and serious adverse events

    Evaluation of the drug reactions, changes in physical examination findings, changes in vital signs, stomatological examination, clinical laboratory testing for systemic safety(including complete blood count, urinalysis, clinical chemistries, coagulation function, liver function, renal function, parathyroid function), and electrocardiography

    Measured: baseline ,at 12 months

  6. Immunogenicity

    Binding antibody and neutralizing antibody formation assays were used to assess number of subjects with anti-denosumab antibody

    Measured: baseline, at 12 months

  7. Population pharmacokinetics analysis

    The pharmacokinetic parameters were described statistically, such as population typical value of clearance rate, estimation precision of typical value, confindence interval of typical value, and inter individual variation

    Measured: baseline, at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start31 Mar 2021
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04591275
Sponsor's protocol ID
CMAB807-III-001
Status last verified
Dec 2024
First submitted
15 Oct 2020
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CMAB807 Injection and Prolia® in people with Postmenopausal Osteoporosis, run by Shanghai Biomabs Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMD percentage change from baseline at lumbar spine(L1~L4) (time frame: baseline, at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04591275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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