跳至主要内容
临床试验/CTRI/2019/06/019792
CTRI/2019/06/019792尚未招募2 期

A randomized controlled, single blind clinical trial for safety and efficacy of grassroots leads in the management of Osteopenia / Osteoporosis among postmenopausal women

ational innovation foundation0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Postmenopausal women, defined as no menstruation for the last 12 months.
  • 2. B.M.D.T. Score -1 to -3.5 at hip, spine and forearm (worst score at any of
  • the three sites to be considered)

排除标准

  • 1. B.M.D. T. score above -1 and less than -3.5
  • 2. All women who are consuming any drug which is known to affect bone metabolism in doses for e.g. SERMs, bisphophonates, calcitonin, Vit. D more than 60,000 units and corticosteroids more than 5mg/day for more than 3 months, methotrexate, anticonvulsants and diuretics.
  • 3. Patients suffering from congenital disorders (Dysosteogenesis and Marfan.s Syndrome)
  • 4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushing.s syndrome)
  • 5. Patients with evidence of malignancy
  • 6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Epilepsy)
  • 7. Patients suffering from chronic hepatic disorder, renal failure or cardiac dysfunction.
  • 8. Patient suffering from uncontrolled DM-2 or uncontrolled hypertension.
  • 8. Patients suffering from Osteomalacia.
  • 9. Patients suffering from Malabsorption syndrome
  • 10. Patients undergone Organ transplantation or on immunosuppressive therapy
  • 11. Prolonged immobilization
  • 12. Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L ( < 9 or >10.5 mg/dL)
  • 13. History of renal stones
  • 14. Long bone fracture in last 6 months.
  • 15. Patient not ready to give an informed consent
  • 16. Subjects who has participated in any other clinical study in last 30 days.
  • 17. Patients with clinical evidence of active and chronic illness as rheumatoid arthritis, gout,SLE, Psoriatic arthritis.

研究者

发起方
ational innovation foundation

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