A Phase 3 Study to Compare Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with Osteoporosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 504

Inclusion Criteria

1.Postmenopausal women aged = 55 and = 85 years
2.Body weight = 50 kg and = 90 kg
3.Diagnosed with osteoporosis, with absolute BMD consistent with T-scores of = -2.5 and = - 4.0 at the lumbar spine (L1-L4 region) as measured by dual-energy X ray absorptiometry (DXA) at screening
4.At least 5 years of postmenopausal status confirmed by follicle-stimulating hormone (FSH) levels at screening
5.At least one hip joint and two vertebrae in L1-L4 region evaluable by DXA

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 378

Exclusion Criteria

1.Previous exposure to Prolia® or any other denosumab biosimilar
2.Previous use of oral bisphosphonates:
a.Used for 3 or more years cumulatively
b.If used for < 3 years, use within the past 12 months prior to screening
3.Use of intravenous bisphosphonates within the past 5 years prior to screening
4.Use of parathyroid hormone or its derivatives, systemic hormone replacement therapy, selective estrogen-receptor modulators, or tibolone or calcitonin within 12 months prior to enrollment
5.Any prior use of fluoride or strontium
6.Systemic glucocorticoids (= 5 mg prednisone equivalent per day or cumulative dose = 50 mg) for more than 10 days within 3 months prior to enrollment
7.Other bone active drugs (i.e. drugs affecting bone metabolism) including heparin, anti epileptics (except for benzodiazepines and pregabalin), antidepressants such as SSRIs, SNRIs, antipsychotics, systemic ketoconazole, ACTH, lithium, protease inhibitors, GnRH agonists, or anabolic steroids within the past 3 months prior to screening or requiring treatment with these agents during the study
8.History of one severe or more than two moderate vertebral fractures per Genant classification as determined by the central reading center
9.History of hip fracture or bilateral hip replacement
10.Total hip or femoral neck T-score <-4.0
11.History and/or presence of atypical femoral fracture
12.Presence of any active healing fracture according to the Investigator’s assessment
13.History of any transplant or chronic immunosuppression
14.Severe liver dysfunction ([ALT] or [AST] > 3 times upper limit of normal)
15.Positive testing for hepatitis B ([HbsAg]) or hepatitis C ([HCV Ab]) virology
16.Known history of human immunodeficiency virus (HIV) infection or positive serology for HIV at screening
17.Significantly impaired renal function (determined by glomerular filtration rate of < 45 mL/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) formula, as calculated by the central laboratory) or receiving dialysis
18.Oral or dental conditions:
a.Osteomyelitis or history and/or presence of osteonecrosis of the jaw (ONJ)
b.Presence of risk factors for ONJ
c.Active dental or jaw condition which requires oral surgery
d.Planned invasive dental procedure
19.Clinically significant leukopenia, neutropenia, or anemia as determined by the Investigator or any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with adherence to study procedures, study completion, or the interpretation of study results
20.Patient with an active infection or history of infection as follows:
a.Any active infection for which systemic anti-infectives were used within 4 weeks prior to randomization
b.A serious infection defined as requiring hospitalization or intravenous anti infectives within 8 weeks prior to ranomization
c.Recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might compromise the safety of the patient
21.Evidence of any of the following conditions per laboratory test results, medical history, electrocardiogram (ECG), DXA, or X-ray review:
a.Uncontrolled hyperthyroidism or hypothyroidism
b.History or current hyperparathyroidism or hypoparathyroidism (intact parathyroid hormone levels not within normal range)
c.Vitamin D deficiency defined as 25 (OH) vitamin D level < 20 ng/mL (< 50 nmol/L)
d.Current hypocalcemia (albumin-adjusted s

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To evaluate the efficacy of ENZ215 when compared to Prolia® in patients with postmenopausal osteoporosis, in terms of change in BMD at the lumbar spine from baseline to Month 12<br>•To compare the AUEC of sCTX levels from baseline to Month 6<br>;Secondary Objective: •To compare the change in sP1NP levels from baseline to Month 6<br>•To compare the change in BMD at lumbar spine from baseline to Month 6<br>•To compare the change in BMD at total hip and femoral neck from baseline to Month 6 and Month 12<br>•To compare the immunogenicity potential of ENZ215 and Prolia®<br>•To compare the safety and tolerability of ENZ215 and Prolia®<br>•To compare the pharmacokinetics of ENZ215 and Prolia®;Primary end point(s): •Percentage change in BMD at lumbar spine (L1-L4 region) measured by DXA from baseline to Month 12<br>•AUEC of sCTX over the initial 6 months (from Day 1 pre-dose to Month 6 pre dose)<br>;Timepoint(s) of evaluation of this end point: Month 12

Secondary Outcome Measures

Name	Time	Method

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