A Study to assess effectiveness and safety of Lupin’s Denosumab (IRO2201A/LUBT014) compared to Prolia®

Phase 3

Completed

• Conditions: Osteopetrosis,

• Registration Number: CTRI/2023/09/057671
• Lead Sponsor: Lupin Limited

Brief Summary

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. Approximately 150 patients are planned to be enrolled in the study

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Study Completion: 2025-01-20
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• 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.
• 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).
• At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA.
• Patients willing to provide written informed consent.

Exclusion Criteria

• Body weight of ≤ 45 kg and ≥ 95 kg at screening.
• Presence of one severe or more than two moderate vertebral fractures as determined by spine X-ray during the screening period.
• Inadequate renal function at the screening defined as patient on dialysis or estimated glomerular filtration rate (eGFR) < 30 mL/min.
• Presence of clinically significant leukopenia, neutropenia, or anaemias judged by the investigator.
• Prior denosumab and strontium or fluoride administration.
• Ongoing and/or prior administration of the following medicines for osteoporosis: a.
• Intravenous bisphosphonates: dose received within 5 years prior to screening.
• Oral bisphosphonates used > 3 years cumulative use, and any dose within 12 months of screening.
• Teriparatide or any parathyroid hormones (PTH) analogues: dose received within 6 weeks prior to screening.
• Tibolone, oral, or topical (e.g., transdermal, intravaginal) estrogen, selective estrogen receptor modulators (SERMs): dose received within 6 weeks prior to screening.
• Calcitonin: dose received within 6 weeks prior to screening.
• Active Vitamin D dose received within 2 weeks prior to screening.
• Systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for ≥ 10 days or a total cumulative dose of ≥ 50 mg) within the past 3 months before screening.
• Other bone active drugs (i.e., drugs affecting bone metabolism) including heparin, anti-epileptics (except for benzodiazepines and pregabalin), systemic ketoconazole, adrenocorticotrophic hormone (ACTH), lithium, protease inhibitors, gonadotropinreleasing hormone (GnRH) agonists, or anabolic steroids within the past 3 months prior to screening.
• Receiving or has received any investigational drug (or is currently using an investigational device) within 3 months before receiving IMP, or at least 10 times the respective elimination half-life (whichever period is longer).
• Abnormal serum calcium (re-test and rescreening is permitted): current hypocalcemia (< 8.4 mg/dL).
• Vitamin D deficiency (25-hydroxy vitamin D levels cut-off at < 12 ng/mL) at screening.
• (Vitamin D repletion/re-test and rescreening is permitted).
• History and/or presence of following bone conditions: bone metastases, renal osteodystrophy, Paget’s disease, osteogenesis imperfect, osteopetrosis, osteomyelitis, Pott’s disease (tuberculosis of spine), Cushing’s syndrome.
• Current or prior use of romosozumab or antisclerostin antibody.
• Current hypoparathyroidism or hyperparathyroidism other than clinically not significant secondary hyperparathyroidism as judged by the investigator.
• Major surgery within 8 weeks before screening or planned, anticipated major surgery during the study.
• History and/or presence of malignancy (except completely cured in situ cervical carcinoma or non-metastatic squamous or basal cell carcinoma of the skin).
• History and/or presence of significant cardiac disease as judged by the investigator.
• Known intolerance to or malabsorption of calcium or Vitamin D.
• Known hypersensitivity of monoclonal antibodies or history of systemic hypersensitivity to any component of the IMPs. 21.
• Contraindications to denosumab therapy (e.g., hypocalcaemia), or calcium or vitamin D supplementation before starting the IMP administration.
• Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the IMP, including latex allergy.
• Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or pre-existing dental disease as assessed by the Investigator.
• Any other clinically significant disorder/condition/disease or lab abnormality that in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in Bone Mineral Density (BMD) at the lumbar spine at Month 12.	12 months
Note: L1-L4 region should be included.	12 months

Secondary Outcome Measures

Name	Time	Method
1 Efficacy Endpoints	Percent change from baseline in BMD at the lumbar spine at Month 6

Trial Locations

Locations (12)

Asopa Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Government Medical College; 🇮🇳 Thiruvananthapuram, KERALA, India

Ishwar Institute of Health Care; 🇮🇳 Aurangabad, MAHARASHTRA, India

K.R Hospital, MMC & RI; 🇮🇳 Mysore, KARNATAKA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Life Point Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Nizam’s Institute of Medical Sciences; 🇮🇳 Hyderabad, TELANGANA, India

Panimalar Medical College Hospital & Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Prime Care Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

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Asopa Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Arvind Asopa

Principal investigator

9829013481

dr.asopa@gmail.com