Postmenopausal women diagnosed with osteoporosis MedDRA version: 20.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Biocon Biologics UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willingness to sign the written ICF, ambulatory, able to follow study instructions and comply with the protocol requirements, and not visually impaired as per the investigator’s opinion to participate in the trial. 2. Postmenopausal women, aged =55 and =65 years) yes F.1.3.1 Number of subjects for this age range 288
Exclusion criteria
Exclusion criteria: 1. Patients with T-score of 1 year continuously will be allowed only after 3 months of washout prior to the screening. Patients receiving PPI for =1 year continuously are not allowed if they plan to continue the use of PPI during the study such that the continuous use of PPI will be >1 year. 8. Patients with ongoing serious infections, or infection requiring parenteral antibiotics within 4 weeks prior to the first administration of the study treatment, or oral antibiotics within 2 weeks prior to the first administration of the study treatment. 9. Evidence of any of the following: a. Patient in bed rest for 2 or more weeks during the last 3 months prior to screening b. Current hyperthyroidism or hypothyroidism. Patients with subclinical hyperthyroidism or subclinical hypothyroidism will be excluded c. History and/or current hyperparathyroidism or hypoparathyroidism d. Patients who have had recurrent episode of hypocalcemia in the past e. Current hypocalcemia or hypercalcemia f. Any bone disease including bone metastasis or metabolic disease which may interfere with the interpretation of the results g. Malignancy within the last 5 years from screening visit h. Height, weight, and girth which may preclude accurate DXA measurements i. Advanced scoliosis or extensive lumbar fusion j. History and/or presence of one severe or 3 or more moderate vertebral fractures k. History and/or presence of hip fracture or bilateral hip replacement or history of atypical femoral fracture l. Presence of an active healing fracture m. History of severe skeletal pain with bisphosphonates n. Oral/dental or periodontal specific conditions as per protocol details o. Any organic or psychiatric disorder or laboratory abnormality or underlying condition which will impact on the trial participation. p. History of presence of a severe allergic reaction. q. Personal/family history of prolonged QT interval syndrome or family history of sudden death. 10. New York Heart Association Class III or IV chronic heart failure, any unstable cardiovascular disease, pulmonary disease, autoimmune disease or ECG abnormalities, which can be judged as clinically significant at the investigator’s discretion. 11. Patient has a planned surgical intervention. 12. One of the specific laboratory test results at screening as per protocol details 13. Allergy to vitamin D or calcium supplements. 14. Participation in a drug study within 90 days or 5 half-lives of the previous drug. 15. Known case of active hepatitis B, hepatitis C or HIV infection. 16. Evidence of alcohol or substance-abuse within the last 12 months prior to screening. 17. Confirmed or suspected with infection with SARS-CoV-2 from screening to randomization, or who has been diagnosed with COVID-19 (a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: a. To demonstrate equivalent efficacy between Bmab 1000 and Prolia based on percentage change from baseline at Week 52 in lumbar spine BMD (Co-primary for EMA and Primary for US FDA) b. To demonstrate pharmacodynamic equivalence between Bmab 1000 and Prolia based on AUEC of the bone resorption marker sCTX from baseline to week 26 (Co-primary for EMA and secondary US FDA);Secondary Objective: Part 1: - To compare other efficacy parameters between Bmab 1000 and Prolia - To compare bone turnover between Bmab 1000 and Prolia - To compare safety and tolerability of 2 admin of Bmab 1000 and Prolia - To compare immunogenicity between Bmab 1000 and Prolia - To assess denosumab serum concentrations following Bmab 1000 and Prolia administration Part 2: - To assess the risk of hypersensitivity and AE up to 6 months after the single transition from Prolia to Bmab 1000 compared with those on Prolia - To assess the risk of immunogenicity after single transition from Prolia to Bmab 1000 compared with those continuing on Prolia Other: - To assess efficacy after single transition from Prolia to Bmab 1000 compared with those to continuing on Prolia - To assess efficacy of 3 doses of Bmab 1000 compared to Prolia - To assess PK & PD: - To assess the AE on Bmab 1000 compared to Prolia - To assess the risk of immunogenicity on Bmab 1000 throughout compared to Prolia throughout;Primary end point(s): - Co-primary endpoint: Percentage change from baseline at Week 52 in the lumbar spine BMD by DXA (Time Frame: Baseline and Week 52) - Co-primary endpoint: AUEC of sCTX from baseline to 26 weeks (Time Frame: Baseline to Week 26) ;Timepoint(s) of evaluation of this end point: Please see above: timepoints added to each end points | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 1: - Percentage change from baseline at Week 26 in lumbar spine BMD by DXA (Time Frame: Baseline and Week 26) - Percentage change from baseline at Weeks 26 and 52 in total hip BMD by DXA (Time Frame: Baseline, Week 26, and Week 52) - Percentage change from baseline at Weeks 26 and 52 in femoral neck BMD by DXA (Time Frame: Baseline, Week 26, and Week 52) - Incidence of fracture up to Week 52 (Time Frame: Baseline up to Week 52) - Cmin of sCTX (Time Frame: Baseline up to Week 26) - Serum concentrations of P1NP (Time Frame: Baseline up to Week 52) - PD parameters of sCTX: Imax, TImax, AUIC (Time Frame: Baseline up to Week 52) - Incidence of TEAEs up to 6 months after the second dose (Time Frame: Baseline up to Week 52 - Incidence of clinically significant changes in vital sign, physical examinations, laboratory safety tests, and ECGs up to 6 months after the second dose (Time Frame: Baseline up to Week 52 - Incidence and titer of ADA, incidence of NAb up to Week 52 (Time Frame: Baseline up to Week 52) - Denosumab concentrations at Weeks 2, 4, 12, 26, 38, and 52 (Time Frame: Baseline up to Week 52) Part 2: - Incidence of TEAEs from the third dose at Week 52 and up to and including Week 78 (Time Frame: from Week 52 up to Week 78) - Incidence of clinically significant changes in physical examinations, laboratory safety tests, ECG and vital signs from the third dose at Week 52 and up to and including Week 78 (Time Frame: from Week 52 up to Week 78) - Incidence of deaths and SAEs from the third dose at Week 52 and up to and including Week 78 (Time Frame: from Week 52 up to Week 78) - Incidence and titer of ADA, incidence of NAb at Week 78 split by serostatus at Week 52 (Time Frame: from Week 52 up to Week 78) Other: - Percentage change from Week 52 at Week 78 in lumbar spine BMD by DXA (Time Frame: from Week 52 up to Week 78) - Percentage change from (original) baseline at Week 78 in lumbar spine, hip and femoral neck BMD by DXA (Time Frame: D | — |
Countries
Estonia, Latvia, Poland, Ukraine, United States
Contacts
Public ContactDeno Phase 3 Clinical Study Team
Biocon Biologics UK Limited
Outcome results
None listed