Evaluation of Safety and Efficacy of Teriparatide in Addition to Calcium And Vitamin D Supplementation in Comparison to Calcium and Vitamin D Supplementation Alone, in Increasing The Bone Mineral Density in Post-menopausal Women with Osteoporosis

SV Ltd B S D Marg, Govandi,Mumbai 400 088Phone: (022) 2556 4048; Fax : (022) 2558 40250 个研究点目标入组 80 人开始时间: 待定最近更新: 2021年11月24日

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•1. Women with at least 3 years of post menopause, aged between 48 and 75 years. 2. Osteoporosis indicated by lumbar spine or femoral neck or total hip T score ≤ -2.5 on Dual energy X-ray absorptiometry (DEXA). 3. Normal thyroid and parathyroid function as indicated by baseline T3, T4 and TSH.4. Willingness to provide an informed and written consent.

•1. Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DEXA. 2. Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D < 20 ng/ml. 3. Patients with serum PTH > 65 pg/ml. 4. Patients with known hypersensitivity to Teriparatide, Vitamin D or Calcium supplements. 5. Patients with hypercalciuria or hypercalcemia. 6. Patients with hyperuremia or known history of gout and other diseases releated to uric acid accumulation. 7. Patients with a history of active or treated tuberculosis. 8. Patients with a history of significant liver disease, kidney disease, gastrointestinal disease or cancer. 9. Patients receiving concomitant medications such as oestrogen or oestrogen related compounds, bisphosphonates, fluorides or calcitonin within the previous 6 months that might have influenced bone mineralization. 10. Patients with clinically significant unstable medical disorders, life threatening disease, or current malignancies. 11. Patients with a BMI of < 18.5 kg/m2. 12 Patients on any of the following medications: Systemic or inhaled corticosteroids, Anticoagulants, Anticonvulsants. 13. Patients who are unwilling or unable to comply with the requirements of the protocol.

发起方

SV Ltd B S D Marg, Govandi,Mumbai 400 088Phone: (022) 2556 4048; Fax : (022) 2558 4025