Clinical trial to compare the efficacy, distribution within the body, safety and immune response between Bmab 1000 and Prolia in Postmenopausal Women with Osteoporosis

Phase 1

Active, not recruiting

• Conditions: Postmenopausal women diagnosed with osteoporosis; MedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-006545-36-PL
• Lead Sponsor: Biocon Biologics UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-25
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 480

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 <80 years at screening. Postmenopausal is defined as 12 months of spontaneous amenorrhea with serum FSH levels =40 mIU/mL
at screening or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
3. Evidence of osteoporosis as assessed by lumbar spine (L1-L4) absolute BMD corresponding to a T-score classification =–2.5 and =–4.0. Bone mineral density measurements should be performed by DXA using Hologic or Lunar densitometers at
screening visit. All DXA scans will be assessed by a central imaging center for this purpose.
4. At least 3 vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA at screening.
5. Patients with body weight =50 to <90 kg at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 288

Exclusion Criteria

1. Patients with T-score of <-4.0 at the lumbar spine, total hip, or femoral neck.
2. Known history of previous exposure to denosumab.
3. Use of any biologic drugs within 90 days or within five half-lives of the drug,
whichever is longer prior to the screening.
4. Known hypersensitivity to denosumab.
5. For prior or ongoing use of any osteoporosis treatment, specific washout periods consideration are added in the protocol
6. Systemic glucocorticosteroids within past 3 months before screening.
7. Other bone active drugs including but not limited to anticoagulants, antiplatelet, anticonvulsants, systemic ketoconazole, adrenocorticotropic hormone, lithium, gonadotropin releasing hormone agonists, and anabolic steroids within the last 3 months. Receipt of PPI for >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified