An academic clinical study to assess the efficacy and safety of Nandrolone decanoate and alendronate as compared to alendronate alone in patients with Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Difference from baseline in BMD/T score (DXA) ward’s triangle, one vertebra femoral neck, hip, greater trochanter, distal 1/3rd radius
研究概览
简要总结
This is an investigator initiated academic clinical study. This will be a prospective, randomized, two-arm, active-controlled, parallel, open label clinical study to assess the efficacy and safety of nandrolone decanoate, alendronate, as compared to alendronate alone in patients with osteoporosis. A minimum of 220 patients with osteoporosis with T score ≤ - 2.5 (WHO) would be enrolled at a single centre. The enrolled patients would be assigned to either of the 2 study groups according to the centralized computer generated randomization in a 1:1 (test: reference) ratio. The eligible patients will then be enrolled and randomized to either of the study groups as per their randomization number on baseline visit (visit 2, day 0). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at month 6 (visit 3) and month 12 (visit 4) for clinical evaluation and answering questionnaires. Enrolled patients will receive either of the study drugs as per their randomization number. In the test arm, nandrolone decanoate 50mg i.m. every 3 weeks for 12 weeks and then every 4 weeks for another 36 weeks. Alendronate 70mg po once a week for a period of 48 weeks.
In the control arm, subjects shall take alendronate 70mg once a week for a period of 48 weeks. Patients will be given calcium 1000 mg/day (in divided doses) along with vitamin D 400 IU/day (in divided doses). Laboratory investigations to be done at screening visit (visit 1), visit 3 (month 6) and visit 4 (month 12) & DXA (Dual energy X-ray absorptiometry) to be done at screening visit (visit 1) and visit 6 (month 12). This will be a parallel group study and all the enrolled patients will be provided the study medications for a treatment period of 12 months.
Efficacy parameters:
· Difference from baseline in BMD/T score (DXA) ward’s triangle, one vertebra femoral neck, hip, greater trochanter, distal 1/3rd radius at the end of the study in the two groups
· Difference from baseline Lean body (muscle) mass and fat mass using DXA in the two groups
· Change from baseline in the intensity of bone pain (VAS) at the end of the study in the two groups
· Change from baseline in the quality of life score in the two groups
· Change from baseline in the Oswestry Low Back Pain Disability Questionnaire score at the end of the study in the two groups.
Safety endpoints:
· Adverse events reported during the study
· Serious adverse events reported during the study
· Overall tolerability evaluation at the end of study in the two groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Ambulatory patients Patients with BMD value consistent with a T-score between ≤ -2.5 at either Ward’s triangle or lumbar spine or greater trochanter or distal 1/3rd radius Written informed consent from the patient Patient literate willing to comply with the protocol requirements.
排除标准
- •History of hypersensitivity to nandrolone or alendronate or any of its excipients Patients with any metabolic bone diseases such as but not limited to osteomalacia or osteogenesis imperfecta, Paget’s disease, Cushing’s disease or Hyperprolactinemia Patients with any malignancy Patients with severe, untreated hypercalcemia or hypocalcaemia Uncontrolled hyperthyroidism or hypothyroidism except patients on stable thyroid hormone replacement therapy for last one year History of hyperparathyroidism History of any surgery within 3 months Administration of bone metabolism drugs within last 6 weeks: Anabolic steroids or testosterone Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide Glucocorticosteroids (5 mg prednisone equivalent per day for more than 10 days) Systemic hormone replacement therapy Selective estrogen receptor modulators (SERMs), e.g., raloxifene Tibolone Calcitonin Anticonvulsants (except benzodiazepines) Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists Received any solid organ or bone marrow transplant or on chronic immunosuppression for any reason Patients with hepatic dysfunction (serum transaminases ≥ 3 x ULN, alkaline phosphatase or bilirubin ≥ 2 x ULN) or renal dysfunction (serum creatinine ≥ 2 mg/dl) Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy Known to have tested positive for human immunodeficiency virus (HIV), HCV or HBsAg Participation in another clinical trial in the past 3 months History of alcohol or drug abuse Any other reason for which the investigator feels that patient should not participate.
结局指标
主要结局
Difference from baseline in BMD/T score (DXA) ward’s triangle, one vertebra femoral neck, hip, greater trochanter, distal 1/3rd radius
时间窗: Visit 1 Screening Visits ( Up to 2 weeks), Visit 2 BaseLine (Day 0), Visit 3 Follow up (Week 24),Visit 4 Week 48) End of study
次要结局
- Difference from baseline Lean body (muscle) mass and fat mass using DXA(Change from baseline in the intensity of bone pain (VAS))