CTRI/2023/09/057671
Active, not recruiting
Phase 3
A multi-center, randomized, double blind, parallel group, phase III study to evaluate efficacy, safety, and immunogenicity of Lupin’s Denosumab (IRO2201A/LUBT014) in comparison with Prolia® in postmenopausal women with osteoporosis. - NI
upin Limited0 sites0 target enrollmentStarted: TBDLast updated:
ConditionsHealth Condition 1: Q782- Osteopetrosis
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- upin Limited
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1\. Postmenopausal women with osteoporosis. A woman is
- •considered postmenopausal if she meets any of the following
- •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
Exclusion Criteria
- •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
- •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
Investigators
Similar Trials
Recruiting
Phase 3
Evaluation of efficacy, safety and immunogenicity of Lupins Denosumab compared to Prolia in postmenopausal women with osteoporosis.JPRN-jRCT2031230117Sakine Michitoshi400
Active, not recruiting
Phase 1
A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasisPsoriasisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2014-001744-38-BEGALDERMA R&D, LLC300
Active, not recruiting
Not Applicable
A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasisPsoriasisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2014-001744-38-HUGALDERMA R&D, LLC300
Active, not recruiting
Phase 1
A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasisEUCTR2014-001744-38-ITGALDERMA RESEARCH & DEVELOPMENT, LLC300
Active, not recruiting
Phase 1
A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasisEUCTR2014-001744-38-DEGALDERMA R&D, LLC300