A multi-center, randomized, double blind, parallel group, phase III study to evaluate efficacy, safety and immunogenicity of Lupins Denosumab in comparison with Prolia in postmenopausal women with osteoporosis.

Sakine Michitoshi0 sites400 target enrollmentStarted: June 7, 2023Last updated: October 17, 2023

Overview

No summary available.

•1\. Postmenopausal women with osteoporosis. A woman is considered postmenopausal if she meets any of the following criteria:
•Lack of menstrual period for at least 12 months prior to screening, for which there is no other pathological or physiological cause.
•Have had surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago.
•(Serum follicle stimulating hormone \[FSH] and serum estradiol level tests can be done at screening in case of uncertainty.)
•2\. Age \>\= 55 and \<\= 80 years at the time of informed consent.3\. Absolute bone mineral density consistent with T\-score \<\= \-2\.5 and \>\= 4\.0 at the lumbar spine as measured by Dual\-energy X\-ray absorptiometry (DXA).
•4\. At least two vertebrae in the L1\-L4 region and at least one hip joint are evaluable by DXA.
•5\. Patients willing to provide written informed consent.

•1\.Body weight of\=\<45 kg and\>\=95 kg at screening.
•2\.Presence of one severe or more than two moderate vertebral fractures as determined by spine X\-ray during the screening period.
•3\.Inadequate renal function at the screening defined as patient on dialysis or estimated glomerular filtration rate(eGFR)\<30 mL/min.
•4\.Presence of clinically significant leukopenia,neutropenia,or anaemias judged by the investigator.
•5\.Prior denosumab and strontium or fluoride administration.
•6\.Ongoing and/or prior administration of the following medicines for osteoporosis:
•a.Intravenous bisphosphonates:dose received within 5 years prior to screening.
•b.Oral bisphosphonates used\>3years cumulative use,and any dose within 12 months of screening.
•c.Teriparatide or any parathyroid hormones(PTH)analogues:dose received within 6 weeks prior to screening.
•d.Tibolone, oral, or topical(e.g.,transdermal,intravaginal)estrogen,selective estrogen receptor modulators(SERMs):dose received within 6 weeks prior to screening.

Sponsor

Sakine Michitoshi