A clinical trial to study the Effects of Denosumab drug in the Treatment of Postmenopausal Osteoporosis

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis

• Registration Number: CTRI/2018/07/014908
• Lead Sponsor: Alkem Laboratories Limited

Brief Summary

This is a prospective, active-controlled, randomized, double blind, multicenter, Phase III study.

Screening Period: It will last up to 1 week;

Treatment Period: It will last for 12 months; all subjects will receive either Biosimilar Denosumab or Innovator Denosumab 60 mg subcutaneously once every 6 months;

Follow-up Period: It will last for 1 month after completion of Treatment Period.

The study is planned to be conducted in 177 subjects (in a ratio of 2:1 i.e. 118 subjects in Biosimilar Denosumab and 59 subjects in Innovator Denosumab arm) at approximately 20 sites in India. After signing the informed consent form, the subjects will be screened for confirming the eligibility for study participation. Eligible subjects will be randomized in a ratio of 2:1 i.e. Biosimilar Denosumab or Innovator Denosumab arms respectively to enter into the treatment period of 12 months.

After completion of 12 months of treatment period, subjects will be followed up for a period of 1 month for safety evaluation.

The total study duration will be approximately 18 months; considering 5 months of recruitment period and 13 months of study period.

Out of 177 subjects who will be enrolled in the study, the first 30 evaluable subjects (i.e. 15 subjects in Biosimilar Denosumab arm and 15 subjects in Innovator Denosumab arm) who provide written informed consent for participation in PK sub-study in-addition to the main study participation; will be considered for PK sub study at baseline visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-10
• Last Update Posted: 2022-02-05

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 177

Inclusion Criteria

• Women with at least 5 years of post-menopause aged > 50 to 80 years; 2.
• Have low bone mass determined by a bone density test (Dual- energy X-ray Absorptiometry [DXA]), Bone Mineral Density (BMD) T-scores < -2.5 standard deviation (SD) at any one of the two sites measured (lumbar spine [L1 – L4] and femoral neck); 3.
• Women giving written, voluntary informed consent for study participation.

Exclusion Criteria

• Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DXA 2.
• Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D test, vitamin D < 20 ng/mL at screening 3.
• Subjects with hyperparathyroidism or hypoparathyroidism at screening 4.
• Subjects with thyroid dysfunction 5.
• Subjects with hypocalcemia or hypercalcemia 6.
• Subjects with Rheumatoid arthritis 7.
• Any previous treatment with bisphosphonates in the last 12 months prior to screening 8.
• Previous treatment with any other drug affecting bone metabolism in the last 3 months prior to screening; 9.
• Subjects with abnormal laboratory findings at screening: ï‚· Total Bilirubin > 1.5 times the Upper Limit of the Normal (ULN) laboratory range; ï‚· ALT and/or AST> 2.5 x ULN; ï‚· Unexplained elevation of ALP; ï‚· Serum Creatinine > ULN 10.
• Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) at screening; 11.
• Subject with any evidence of metabolic bone disease other than osteoporosis, which may interfere with the interpretation of the findings, such as Osteomalacia, Osteogenesis Imperfecta, Paget’s disease, Cushing’s disease, Hyperprolactinemia.
• Subject with any malignancy 13.
• Subjects with known hypersensitivity to Denosumab or any of its excipients; 14.
• Any of the following Oral/Dental conditions: ï‚· Prior history or current evidence of osteomyelitis or osteonecrosis of jaw ï‚· Active dental or jaw condition which requires oral surgery ï‚· Planned invasive dental procedure ï‚· Non-healed dental or oral surgery 15.
• Malabsorption syndrome or any gastrointestinal disorders that are associated with malabsorption 16.
• Subjects with clinical evidence of active or chronic infective illness 17.
• Patients on immunosuppressive therapy 18.
• Any significant medical illness that is preventing the subject from study participation 19.
• Subjects who are unwilling or unable to comply with the requirements of the protocol 20.
• Subject who has participated in any other clinical study in last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy and safety of Biosimilar Denosumab (Enzene Biosciences Limited) with Innovator Denosumab in subjects with postmenopausal osteoporosis	Percent change in Lumbar and Femoral neck Bone Mineral Density (BMD) from baseline to Month 6 and Month 12 of will be evaluated to provide the mean difference of treatments

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacodynamics (PD) response of study drugs in postmenopausal osteoporosis	To assess the pharmacokinetics (PK) profile of Biosimilar Denosumab (Enzene Biosciences Limited) and Innovator Denosumab in subset of subjects (a total of 30 evaluable subjects i.e. 15 subjects in Biosimilar Denosumab arm and 15 subjects in Innovator Denosumab arm) with postmenopausal osteoporosis

Trial Locations

Locations (25)

All India Institute of Medical Sciences Bhubaneswar; 🇮🇳 Cuttack, ORISSA, India

All India Institute of Medical Sciences,; 🇮🇳 Delhi, DELHI, India

 Getwell Hospital and Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

B.J. Medical College; 🇮🇳 Ahmadabad, GUJARAT, India

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

GMERS Medical College and Civil Hospital Sola; 🇮🇳 Ahmadabad, GUJARAT, India

Govt. Medical College; 🇮🇳 Kozhikode, KERALA, India

Grant Medical College and SirJJ Group of Hospitals; 🇮🇳 (Suburban), MAHARASHTRA, India

IPGMER and SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

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

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All India Institute of Medical Sciences Bhubaneswar

🇮🇳Cuttack, ORISSA, India

Dr Sujit Kumar Tripathy

Principal investigator

9438884155

suijtortho@aiimsbhubaneswar.edu.in