A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前:Zhenlin Zhang, doctor
- 電話番号:13621673716
- メール:zzl2002@medmail.com.cn
研究連絡先のバックアップ
- 名前:Jiemei Gu, doctor
- 電話番号:13916925072
- メール:gujiemei81@163.com
研究場所
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Shanghai
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Shanghai、Shanghai、中国、200233
- 募集
- Shanghai Sixth People's Hospital
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コンタクト:
- Zhenlin Zhang, doctor
- 電話番号:13621673716
- メール:zzl2002@medmail.com.cn
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主任研究者:
- Zhenlin Zhang, doctor
-
副調査官:
- Jiemei Gu, doctor
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:LY06006 60mg
injection Interventions: Drug: LY06006 Injection; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D |
60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total
他の名前:
|
プラセボコンパレーター:Placebo
injection Interventions: Drug: Placebo; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D |
60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
時間枠:Baseline and Month 12
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Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12
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Baseline and Month 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
時間枠:Baseline and Month 6
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Percent Change From Baseline in BMD at the Lumbar Spine at Month 6
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Baseline and Month 6
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Percent Changes in total hip BMD
時間枠:Baseline,Month 6 and Month 12
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Percent Changes in total hip BMD from baseline at 6 and 12 months of treatment
|
Baseline,Month 6 and Month 12
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Percent Changes in femoral neck BMD
時間枠:Baseline,Month 6 and Month 12
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Percent Changes in femoral neck BMD from baseline at 6 and 12 months of treatment
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Baseline,Month 6 and Month 12
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Percent Changes in trochanteric BMD
時間枠:Baseline,Month 6 and Month 12
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Percent Changes in trochanteric BMD from baseline at 6 and 12 months of treatment
|
Baseline,Month 6 and Month 12
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Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline
時間枠:Baseline, Month 1, Month 6 and Month 12
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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
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Baseline, Month 1, Month 6 and Month 12
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Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline
時間枠:Baseline, Month 1, Month 6 and Month 12
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Percent Change From Baseline in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline at Month 1, Month 6, and Month 12
|
Baseline, Month 1, Month 6 and Month 12
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Zhenlin Zhang, doctor、Shanghai 6th People's Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
LY06006の臨床試験
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Luye Pharma Group Ltd.Shan Dong Boan Biotechnology Co., Ltd積極的、募集していない
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Luye Pharma Group Ltd.Parexel完了