A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

NCT05060406 | Unknown Phase 3

• 1 other identifier: LY06006/CT-CHN-302
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine

  Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12

  Baseline and Month 12

Secondary Outcomes (6)

• Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine

  Baseline and Month 6

• Percent Changes in total hip BMD

  Baseline,Month 6 and Month 12

• Percent Changes in femoral neck BMD

  Baseline,Month 6 and Month 12

• Percent Changes in trochanteric BMD

  Baseline,Month 6 and Month 12

• Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline

  Baseline, Month 1, Month 6 and Month 12

Study Arms (2)

LY06006 60mg

EXPERIMENTAL

injection Interventions: Drug: LY06006 Injection； Dietary Supplement: Elemental Calcium； Dietary Supplement: Vitamin D

Drug: LY06006

Placebo

PLACEBO COMPARATOR

injection Interventions: Drug: Placebo； Dietary Supplement: Elemental Calcium； Dietary Supplement: Vitamin D

Drug: LY06006

Interventions

LY06006 DRUG

60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total

Also known as: recombinant human monoclonal anti-RANKL antibody injection

LY06006 60mg; Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Gender Eligibility Details: Postmenopausal woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal woman, ages ≥50 to ≤85 years.≥3 years postmenopausal, which can be≥3 years of spontaneous amenorrhea or ≥3 years post-surgical bilateral oophorectomy. If \< 60 years of age and had hysterectomy but ovarian retention, require follicle stimulating hormone (FSH) levels ≥40U/L.

You may not qualify if:

• Low BMD (BMD absolute value consistent with a T-score≤-2.5 and \>-4.0 at either the lumbar spine or total hip). The BMD equivalents by T-score thresholds for each DXA scanner manufacturer are provided below.
• Have at least one of the following risk factors:
• history of fragility fracture
• parental history of hip fracture
• low body weight (BMI≤19kg/m2)
• elderly (age≥65y)
• current smoker
• Voluntarily signed written informed consent
• Bone/metabolic disease:
• Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,
• Paget's disease
• Cushing's disease
• Hyperprolactinemia
• Hypopituitarism
• Acromegaly

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead
• Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor): collaborator

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zhenlin Zhang, doctor

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenlin Zhang, doctor

CONTACT

13621673716; zzl2002@medmail.com.cn

Jiemei Gu, doctor

CONTACT

13916925072; gujiemei81@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: September 29, 2021
• Study Start: June 30, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)