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

Primary Purpose

Postmenopausal Osteoporosis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
LY06006
Sponsored by
Luye Pharma Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.

    Exclusion Criteria:

  2. 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.
  3. Have at least one of the following risk factors:

    1. history of fragility fracture
    2. parental history of hip fracture
    3. low body weight (BMI≤19kg/m2)
    4. elderly (age≥65y)
    5. current smoker
  4. Voluntarily signed written informed consent

Exclusion criteria

  1. Bone/metabolic disease:

    1. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,
    2. Paget's disease
    3. Cushing's disease
    4. Hyperprolactinemia
    5. Hypopituitarism
    6. Acromegaly
    7. Current hyperparathyroidism or hypoparathyroidism by medical record.
    8. Current hyperthyroidism or hypothyroidism (allowed if having normal hormone level on thyroid hormone replacement therapy or 5.5μIU/mL<thyroid-stimulating hormone (TSH) level≤10.0μIU/mL, but the serum thyroxine (T4) is within the normal range.
    9. Malabsorption syndrome or any gastrointestinal disorders associated with malabsorption, for example Crohn's Disease and chronic pancreatitis.
    10. Hypocalcemia or hypercalcemia, or serum albumin corrected blood calcium level is not within the normal range of the laboratory;
    11. Vitamin D deficiency: 25 hydroxy vitamin D (25OHD) level <20 ng/mL. (allowed 200,000 units of vitamin D2 injection (trade name: Futai®) once during the screening period, and re-test the 25OHD level once. Those with 25OHD level ≥20 ng/mL can be included
    12. Others such as rheumatoid arthritis, gout, multiple myeloma and so on.
  2. Subjects with a history of greater than 2 vertebral fractures.
  3. Malignancy within the 5 years before enrollment (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ).
  4. Severe renal disease, creatinine clearance <30mL/min
  5. Liver or biliary diseases:

    1. Cirrhosis of the liver;
    2. Biliary tract abnormalities (except asymptomatic gallstones);
    3. Positive Hepatitis C virus (HCV) antibody;
    4. Positive hepatitis B surface antigen (HBsAg) test with the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test ≥1×103 copies/mL (if positive HBsAg with the peripheral blood HBV DNA titer test <1× 103 copies/mL, the subject is eligible for selection if the investigator believes that the subject is in a stable phase of chronic hepatitis B and will not increase the risk of the subject,;
    5. Alkaline phosphatase <lower limit of normal (LLN); alkaline phosphatase or total bilirubin ≥ 1.5 times the upper limit of normal (ULN); serum aspartate aminotransferase (AST) ≥ 2.0×ULN; serum alanine Acid aminotransferase (ALT) ≥2.0×ULN;
  6. Oral/Dental Diseases

    1. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
    2. Active dental or jaw condition which requires oral surgery.
    3. Planned invasive dental procedure.
    4. Non-healed dental or oral surgery.
  7. DXA measurements:

    1. Less than two lumbar vertebrae evaluable for DXA measurements.
    2. Height, weight, or girth that could preclude accurate DXA measurements.
  8. Administration of the following medications:

    1. RANKL inhibitor, fluoride or strontium salt or intravenous bisphosphonate within the past 5 years;
    2. Oral bisphosphonates, allowed if patients had the following conditions :

      • Cumulative use> 3 months but <3 years: ≥ 6 months before the last medication was taken from the screening visit;
      • Cumulative use ≤3 months;
    3. parathyroid hormone (PTH) or parathyroid hormone analogs (PTHa) within 6 weeks before screening, such as teriparatide; anabolic hormones or testosterone; glucocorticoids (equivalent to> 5 mg/day strength Pine> 10 days); systemic hormone replacement therapy; selective estrogen receptor modulators (SERMs), such as raloxifene; tibolone; calcitonin; active vitamin D and its analogs; other bone active drugs including anticonvulsants (except benzodiazepines) and heparin; long-term systemic use of ketoconazole, androgens, corticotropin, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, Gonadotropin releasing hormone agonist;
  9. Positive human immunodeficiency virus (HIV) antibody.
  10. Self-reported alcohol or drug abuse [defined as drinking an average of 14 units or more of alcoholic beverages per week in the 3 months before screening (1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine)]
  11. Known allergy to the treatment drugs used in the research protocol, including allergy to the test drugs
  12. Have received any other experimental drug treatment or prior participation in another interventional clinical trial within 3 months before screening
  13. Other severe acute or chronic diseases, psychiatric disorder or abnormal laboratory tests, etc., in the opinion of the investigator, not suitable for participating in this research.

Sites / Locations

  • Shanghai Sixth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY06006 60mg

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
Percent Change From Baseline in BMD at the Lumbar Spine at Month 6
Percent Changes in total hip BMD
Percent Changes in total hip BMD from baseline at 6 and 12 months of treatment
Percent Changes in femoral neck BMD
Percent Changes in femoral neck BMD from baseline at 6 and 12 months of treatment
Percent Changes in trochanteric BMD
Percent Changes in trochanteric BMD from baseline at 6 and 12 months of treatment
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1, Month 6, and Month 12
Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline
Percent Change From Baseline in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline at Month 1, Month 6, and Month 12

Full Information

First Posted
April 20, 2021
Last Updated
September 17, 2021
Sponsor
Luye Pharma Group Ltd.
Collaborators
Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)
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1. Study Identification

Unique Protocol Identification Number
NCT05060406
Brief Title
A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luye Pharma Group Ltd.
Collaborators
Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. Primary Objective: To evaluate the efficacy of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture. Secondary Objectives: To evaluate the safety of LY06006. To evaluate the immunogenicity of LY06006. Population pharmacokinetic analysis of LY06006.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
448 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY06006 60mg
Arm Type
Experimental
Arm Description
injection Interventions: Drug: LY06006 Injection; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
injection Interventions: Drug: Placebo; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D
Intervention Type
Drug
Intervention Name(s)
LY06006
Other Intervention Name(s)
recombinant human monoclonal anti-RANKL antibody injection
Intervention Description
60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total
Primary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
Description
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12
Time Frame
Baseline and Month 12
Secondary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
Description
Percent Change From Baseline in BMD at the Lumbar Spine at Month 6
Time Frame
Baseline and Month 6
Title
Percent Changes in total hip BMD
Description
Percent Changes in total hip BMD from baseline at 6 and 12 months of treatment
Time Frame
Baseline,Month 6 and Month 12
Title
Percent Changes in femoral neck BMD
Description
Percent Changes in femoral neck BMD from baseline at 6 and 12 months of treatment
Time Frame
Baseline,Month 6 and Month 12
Title
Percent Changes in trochanteric BMD
Description
Percent Changes in trochanteric BMD from baseline at 6 and 12 months of treatment
Time Frame
Baseline,Month 6 and Month 12
Title
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline
Description
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1, Month 6, and Month 12
Time Frame
Baseline, Month 1, Month 6 and Month 12
Title
Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline
Description
Percent Change From Baseline in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline at Month 1, Month 6, and Month 12
Time Frame
Baseline, Month 1, Month 6 and Month 12

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal woman
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Exclusion criteria Bone/metabolic disease: Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, Paget's disease Cushing's disease Hyperprolactinemia Hypopituitarism Acromegaly Current hyperparathyroidism or hypoparathyroidism by medical record. Current hyperthyroidism or hypothyroidism (allowed if having normal hormone level on thyroid hormone replacement therapy or 5.5μIU/mL<thyroid-stimulating hormone (TSH) level≤10.0μIU/mL, but the serum thyroxine (T4) is within the normal range. Malabsorption syndrome or any gastrointestinal disorders associated with malabsorption, for example Crohn's Disease and chronic pancreatitis. Hypocalcemia or hypercalcemia, or serum albumin corrected blood calcium level is not within the normal range of the laboratory; Vitamin D deficiency: 25 hydroxy vitamin D (25OHD) level <20 ng/mL. (allowed 200,000 units of vitamin D2 injection (trade name: Futai®) once during the screening period, and re-test the 25OHD level once. Those with 25OHD level ≥20 ng/mL can be included Others such as rheumatoid arthritis, gout, multiple myeloma and so on. Subjects with a history of greater than 2 vertebral fractures. Malignancy within the 5 years before enrollment (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ). Severe renal disease, creatinine clearance <30mL/min Liver or biliary diseases: Cirrhosis of the liver; Biliary tract abnormalities (except asymptomatic gallstones); Positive Hepatitis C virus (HCV) antibody; Positive hepatitis B surface antigen (HBsAg) test with the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test ≥1×103 copies/mL (if positive HBsAg with the peripheral blood HBV DNA titer test <1× 103 copies/mL, the subject is eligible for selection if the investigator believes that the subject is in a stable phase of chronic hepatitis B and will not increase the risk of the subject,; Alkaline phosphatase <lower limit of normal (LLN); alkaline phosphatase or total bilirubin ≥ 1.5 times the upper limit of normal (ULN); serum aspartate aminotransferase (AST) ≥ 2.0×ULN; serum alanine Acid aminotransferase (ALT) ≥2.0×ULN; Oral/Dental Diseases Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw. Active dental or jaw condition which requires oral surgery. Planned invasive dental procedure. Non-healed dental or oral surgery. DXA measurements: Less than two lumbar vertebrae evaluable for DXA measurements. Height, weight, or girth that could preclude accurate DXA measurements. Administration of the following medications: RANKL inhibitor, fluoride or strontium salt or intravenous bisphosphonate within the past 5 years; Oral bisphosphonates, allowed if patients had the following conditions : Cumulative use> 3 months but <3 years: ≥ 6 months before the last medication was taken from the screening visit; Cumulative use ≤3 months; parathyroid hormone (PTH) or parathyroid hormone analogs (PTHa) within 6 weeks before screening, such as teriparatide; anabolic hormones or testosterone; glucocorticoids (equivalent to> 5 mg/day strength Pine> 10 days); systemic hormone replacement therapy; selective estrogen receptor modulators (SERMs), such as raloxifene; tibolone; calcitonin; active vitamin D and its analogs; other bone active drugs including anticonvulsants (except benzodiazepines) and heparin; long-term systemic use of ketoconazole, androgens, corticotropin, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, Gonadotropin releasing hormone agonist; Positive human immunodeficiency virus (HIV) antibody. Self-reported alcohol or drug abuse [defined as drinking an average of 14 units or more of alcoholic beverages per week in the 3 months before screening (1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine)] Known allergy to the treatment drugs used in the research protocol, including allergy to the test drugs Have received any other experimental drug treatment or prior participation in another interventional clinical trial within 3 months before screening Other severe acute or chronic diseases, psychiatric disorder or abnormal laboratory tests, etc., in the opinion of the investigator, not suitable for participating in this research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenlin Zhang, doctor
Phone
13621673716
Email
zzl2002@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiemei Gu, doctor
Phone
13916925072
Email
gujiemei81@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenlin Zhang, doctor
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenlin Zhang, doctor
Phone
13621673716
Email
zzl2002@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Zhenlin Zhang, doctor
First Name & Middle Initial & Last Name & Degree
Jiemei Gu, doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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

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