Efficacy, safety, PK, PD, and immunogenicity of BP16 in post-menopausal osteoporosis

Phase 1

Recruiting

• Conditions: Post-Menopausal Osteoporosis; MedDRA version: 20.0Level: PTClassification code: 10031285Term: Osteoporosis postmenopausal Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2023-503790-37-00
• Lead Sponsor: Curateq Biologics Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 635

Inclusion Criteria

Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the investigator., Post-menopausal women with age between 55 and 80 years (both inclusive) at screening visit., Evidence of osteoporosis as assessed by LS absolute BMD corresponding to T-score of -2.5 and -4.0 (both inclusive) at lumbar spine, Body weight: 50 to 90 kg (both inclusive)., At least 3 intact, nonfractured vertebrae in the L1-L4 region are evaluable by DXA (as assessed by central imaging center).

Exclusion Criteria

Known history of hypersensitivity or allergic reactions to denosumab or any of its excipients., Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab)., T-score of <-4.0 at either region of lumbar spine, total hip, or femoral neck., Prior or ongoing use of any anti-osteoporotic treatment. For the rest of the exclusion criteria, please refer to the study protocol.

Study & Design

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