Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis: A Randomized Controlled Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- Change of CTX from baseline after administration
研究概览
简要总结
This is a randomized, controlled, and exploratory study designed to evaluate the chronotherapeutic effects of teriparatide administration in postmenopausal osteoporosis. Twenty-eight participants (age 60-70 years, lumbar spine T-score ≤-3.0) will undergo 1:1 randomization to receive 20 µg/day teriparatide subcutaneously at either 08:00 or 20:00 for 12 weeks. Standardized supplementation with calcium (1,000-1,500 mg/day) and cholecalciferol (800-1,200 IU/day) will be maintained. Primary endpoints are between-group differences in serum CTX and P1NP profiles, quantified at baseline, 4-week interim, and 12-week endpoint. The secondary outcomes will assess safety during the trial.
详细描述
This is a randomized, controlled, and exploratory study designed to evaluate the chronotherapeutic effects of teriparatide administration in postmenopausal osteoporosis. The trial protocol was approved by the Peking University Third Hospital Medical Science Research Ethics Committee. This trial intends to enroll postmenopausal osteoporosis patients admitted to the Department of Orthopedics of Peking University Third Hospital. Subjects who meet the inclusion and exclusion criteria can be enrolled in this trial after signing the informed consent form. Each trial group plans to enroll 14 subjects, with a total of 28 subjects. Eligible participants will be randomly assigned (1:1) to either subcutaneous injection of 20 μg teriparatide at 08:00 a.m in the morning (Group A) and subcutaneous injection of 20 μg teriparatide at 20:00 p.m in the evening(Group B). The specific time of drug administration for each patient every day needs to be recorded in the diary card. All subjects will be given calcium (1000-1500 mg/day) and vitamin D (800-1200 IU/day) simultaneously during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 60-70 years (inclusive).
- •Naturally postmenopausal women with≥5 years since last menses.
- •DXA-measured BMD T-score≤-3.0 at lumbar spine (L1-L4) and/or total hip at screening.
- •The concentration of 25-hydroxyvitamin D (25-OH)D is ≥20 ng/ml. If the subject meets all other inclusion and
排除标准
- •, it is allowed to retest the 25-OHD concentration after administering vitamin D to the subject.
- •Normal-range serum parameters:
- •Intact PTH: 15-65 pg/mL Total calcium: 2.20-2.70 mmol/L.
- •Exclusion Criteria:
- •Subjects with bone metabolic diseases besides osteoporosis:
- •Other metabolic bone diseases, such as osteomalacia, osteogenesis imperfecta, Paget's disease；
- •Cushing's syndrome;
- •Hyperprolactinemia;
- •Use of medications that affect bone metabolism before screening:
- •Use of intravenous bisphosphonates, fluoride, or strontium within 2 years; Use of teriparatide or denosumab for osteoporosis within 6 months; Oral bisphosphonates for osteoporosis with the last dose within 1 year (if used within 1 year but with a cumulative use of ≤1 month, the subject is eligible); Continuous use of calcitonin for more than 3 months with the last dose within 1 year.
- •History of malignancy within 5 years, or bone metastasis, except for tumors that are expected to be cured after treatment (such as completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or breast ductal carcinoma, etc.).
- •Hypocalcemia and hypercalcemia.
- •Elevated alkaline phosphatase of unknown cause.
- •History of fractures.
- •Uncontrolled comorbidities, including heart failure with New York Heart Association (NYHA) functional class III or above, glycated hemoglobin >8.5%, and severe arrhythmias.
- •Allergy to teriparatide.
- •Currently participating in another drug clinical trial.
- •Subjects deemed unsuitable for enrollment in this study by the investigator.
研究组 & 干预措施
Morning (8:00) administration group of teriparatide
A total of 14 subjects will be included. Teriparatide injection (20 µg, subcutaneous injection, once daily) will be administered in the morning (around 8:00 a.m.) every day for 12 weeks
干预措施: Morning administration group of teriparatide (Behavioral)
Evening (20:00) administration group of teriparatide
A total of 14 subjects will be included. Teriparatide injection (20 µg, subcutaneous injection, once daily) will be administered in the evening (around 20:00 p.m.) every day for 12 weeks
干预措施: Evening administration group of teriparatide (Behavioral)
结局指标
主要结局
Change of CTX from baseline after administration
时间窗: Within 12 weeks
Compare the morning and evening dosing groups regarding the changes in serum CTX from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide.
Change of P1NP from baseline after administration
时间窗: Within 12 weeks
Compare the morning and evening dosing groups regarding the changes in serum P1NP from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide.
Change of PTH from baseline after administration
时间窗: Within 12 weeks
Compare the morning and evening dosing groups regarding the changes in serum PTH from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide.
次要结局
- Safety Evaluation(Within 12 weeks)