CTRI/2025/09/095133尚未招募3 期
A Phase III, Randomized, Open Label, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Abaloparatide Injection in Comparison with Teriparatide Injection for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture.
Precise Biopharma Pvt. Ltd.,25 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年10月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 25
- 主要终点
- Percent change in Bone Mineral Density (BMD) at 24 weeks
研究概览
简要总结
Postmenopausal women with osteoporosis at high risk fracture will be screened (visit 1) within 2 to 3 weeks prior to their randomization. The eligible patients will then be randomized to either of the 2 study groups as per their randomization number on randomization visit (visit 3, day 1). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 4), week 12 (visit 5), week 18 (visit 6), week 24 (visit 7 – end of treatment visit) and week 26 (visit 8 - end of study visit). This will be a parallel group study and all the enrolled patients will be instructed to take the study drugs as per the prescribed regimen for a treatment period of 24 weeks.
After confirming the inclusion/exclusion criteria the patient will be randomized and provided with study drug at randomization visit. Patients will be provided with a patient diary at randomization visit, which needs to be brought along with each subsequent visit till end of study visit. Follow-up visits will be done on week 4 / day 29±4, week 12 / day 85±4, week 18 / day 127±4, week 24 / day 169±4 (end of treatment visit) and week 26 / day 183±4 / end of study visit of treatment to assess efficacy, safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •The patient is a healthy ambulatory postmenopausal woman from 45 to 75 years of age (both inclusive) with the documented diagnosis of osteoporosis.
- •The patient has been postmenopausal for at least 5 years.
- •Postmenopausal status will be established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (FSH) value of greater than or equal to 30 IU/L.
- •The patient has a bone mineral density T-score less than or equal to -2.5 and greater than -5.0 at the lumbar spine (L1-L4) or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years.
- •Postmenopausal women older than 65 who meet the above fracture criteria but have a T-score less than or equal to -2.0 and greater than -5.0 may be enrolled.
- •Women older than 65 who do not meet the fracture criteria may be enrolled if their T-score is less than or equal to -3.0 and greater than -5.
- •The patient is in good general health as determined by medical history and physical examination (including vital signs), has a body mass index (BMI) of 18.5 to 33 kg/m2 (both inclusive), and is without evidence of clinically significant abnormality in the opinion of the Investigator.
- •Any required concomitant medications which are not excluded (e.g., statins or antihypertensives) may be continued through the study.
- •Every effort should be made to maintain the medication at a stable dose throughout the study, patient to the Investigator’s medical judgment.
- •The patient has serum calcium (albumin-corrected), PTH (1-84), serum phosphorus and alkaline phosphatase values all within the normal range during the screening period.
- •Patients with minor elevations or reductions in serum calcium may be enrolled if serum ionized calcium is normal.
- •Any patient with an elevated alkaline phosphatase value, and who meets all other entry criteria, would be required to have a normal bone-specific alkaline phosphatase result to be enrolled.
- •The patient has serum 25-hydroxy Vitamin D values above 15 ng/mL and within 3 times the upper normal range.
- •The patient’s resting 12-lead electrocardiogram obtained during screening shows no clinically significant abnormality and QTc less than or equal to 470 msec (Bazett’s correction).
- •The patient’s systolic blood pressure is greater than or equal to 100 and less than or equal to 155 mmHg, diastolic blood pressure is greater than or equal to 40 and less than or equal to 95 mmHg, and heart rate is greater than or equal to 45 and less than or equal to 100 bpm (sitting or supine).
- •The patient has no clinically significant abnormality of serum hemoglobin, hematocrit, WBC and platelets, or usual serum biochemistry: electrolytes, renal function, liver function and serum proteins.
- •The patient has read, understood, and signed the written informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements.
排除标准
- •General exclusion criteria:
- •Patients with a history of more than four spine fractures, mild or moderate, or any severe fractures.
- •Patients with presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least two radiologically evaluable vertebrae within L1-L
- •Patients with unevaluable hip bone mineral density or patients who have undergone bilateral hip replacement (unilateral hip replacement is acceptable).
- •Patients with unexplained elevation of serum alkaline phosphatase.
- •Patients with a history of radiotherapy (radiation therapy), other than radioiodine.
- •Patients with a history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, or metabolic diseases or immunologic, emotional, and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the patient.
- •Patients with a history of Cushing’s disease, hyperthyroidism, hypo- or hyperparathyroidism, or malabsorptive syndromes within the past year.
- •Patients with a history of significantly impaired renal function (serum creatinine greater than 2.0 mg/dL).
- •Patients with a history of any cancer within the past 5 years.
- •Patients with a history of osteosarcoma at any time.
- •Patients with a history of nephrolithiasis or urolithiasis within the past 5 years.
- •Patients with decrease of 20 mmHg or more in systolic blood pressure or 10 mmHg or more in diastolic blood pressure from supine to standing (5 minutes lying and 3 minutes standing) and/or any symptomatic hypotension at screening.
- •Patients known to be positive for Hepatitis B, Hepatitis C, HIV-1, or HIV-
- •Medication-related exclusion criteria:
- •Patients with a known history of hypersensitivity to any of the test materials or related compounds.
- •Patients with prior treatment with PTH or PTHrP drugs.
- •Patients with prior treatment with bisphosphonates [patients who had a short course of bisphosphonate treatment (3 months or less) and were intolerant of the treatment are not excluded from study participation], fluoride or strontium in the past 5 years, prior treatment with gallium nitrate, or with as yet unapproved bone-acting investigational agents at any time.
- •Patients with prior treatment with Denosumab, Calcitonin, selective estrogen receptor modulators (such as Raloxifene or Tamoxifen), Tibolone, or anabolic steroids in the past 12 months.
- •Estrogens administered as hormone replacement therapy, with or without progestins, are not exclusionary.
- •Patients’ treatment with anticonvulsants that affect Vitamin D metabolism (Phenobarbital, Phenytoin, Carbamazepine, or Primidone) or with chronic heparin within the 6 months prior to the screening period.
- •Patients’ daily treatment with oral, intranasal, or inhaled corticosteroids within the 12 months prior to the screening period.
- •Occasional use of corticosteroids (for seasonal allergies or asthma) is not exclusionary.
- •Patients with exposure to general anesthesia within the 12 weeks prior to the screening period.
- •Patients with exposure to an investigational drug within the 12 months prior to the screening period.
- •Lifestyle-related exclusion criteria:
- •Patients with abnormal nutritional status (abnormal diets, excessive or unusual vitamin or herbal intakes, malabsorption, significant recent weight change), Vitamin D intake of greater than or equal to 4000 IU/day (Vitamin D given during the pretreatment period to treat Vitamin D deficiency is permissible) or Vitamin A intake of greater than or equal to 10,000 IU/day.
- •Patient is known to abuse alcohol or use illegal drugs within 12 months of the screening period.
结局指标
主要结局
Percent change in Bone Mineral Density (BMD) at 24 weeks
时间窗: Visit 1 - Screening visit (Up to 2 weeks) | Visit 5 - Follow up visit / Week 12 (Day 85±4) | Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169±4)
Lumbar spine (L1-L4) BMD
时间窗: Visit 1 - Screening visit (Up to 2 weeks) | Visit 5 - Follow up visit / Week 12 (Day 85±4) | Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169±4)
Total hip BMD
时间窗: Visit 1 - Screening visit (Up to 2 weeks) | Visit 5 - Follow up visit / Week 12 (Day 85±4) | Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169±4)
Femoral neck BMD
时间窗: Visit 1 - Screening visit (Up to 2 weeks) | Visit 5 - Follow up visit / Week 12 (Day 85±4) | Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169±4)
次要结局
- Percent change in Bone Turnover Markers (BTMs) at 24 weeks(P1NP (Procollagen Type 1 N-terminal Propeptide) – Bone formation marker)
- Time to maximum suppression of CTX (bone resorption marker)(Visit 1 - Screening visit (Up to 2 weeks))
- Correlation between BTM changes and BMD improvement(Visit 1 - Screening visit (Up to 2 weeks))
- Proportion of patients achieving greater than or equal to 3 percent increase in Lumbar Spine BMD at 24 weeks(Visit 1 - Screening visit (Up to 2 weeks))
- Treatment emergent adverse events reported during the study.(Throughout the Study.)
- Serious adverse events (SAE) reported during the study.(Throughout the Study.)
- Changes in serum calcium levels (risk of hypercalcemia/hypocalcemia)(Visit 3 - Randomization visit (Day 1))
- Orthostatic hypotension events(Visit 3 - Randomization visit (Day 1))
研究者
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.
研究点 (25)
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