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
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- At the end of study drug treatment (360 days from start of treatment) in Groups I and II: Increase in Bone Mineral density (BMD) from baseline at Lumbar spine L 1 to L 4.
研究概览
简要总结
This proposed study is a randomized, open label, prospective, controlled, multicentric, between group comparison trial, eligible and consenting post-menopausal patients will be enrolled and randomized into two groups - Group I or Group II. Group I and Group II, will receive oral calcium supplementation of 1000 mg of elemental calcium and Vitamin D 500 IU per day, in two divided doses. In addition, Group I will receive Teriparatide sc injection 20 µg per day. All the patients will be assessed for primary endpoint, viz., increase in bone mineral density at Lumbar spine L 1 to L 4 from baseline, and secondary endpoints such as increase in bone mineral density at femoral neck and total hip regions, change from baseline in biomarkers of bone formation and bone resorption and occurrence of adverse events. This study will be conducted in approximately 5 -6 centers in India to recruit approximately 80 patients.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Women with at least 3 years of post menopause, aged between 48 and 75 years.
- •Osteoporosis indicated by lumbar spine or femoral neck or total hip T score ≤ -2.5 on Dual energy X-ray absorptiometry (DEXA).
- •Normal thyroid and parathyroid function as indicated by baseline T3, T4 and TSH.
- •Willingness to provide an informed and written consent.
排除标准
- •Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DEXA.
- •Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D < 20 ng/ml.
- •Patients with serum PTH > 65 pg/ml.
- •Patients with known hypersensitivity to Teriparatide, Vitamin D or Calcium supplements.
- •Patients with hypercalciuria or hypercalcemia.
- •Patients with hyperuremia or known history of gout and other diseases releated to uric acid accumulation.
- •Patients with a history of active or treated tuberculosis.
- •Patients with a history of significant liver disease, kidney disease, gastrointestinal disease or cancer.
- •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.
- •Patients with clinically significant unstable medical disorders, life threatening disease, or current malignancies.
- •12 Patients on any of the following medications: Systemic or inhaled corticosteroids, Anticoagulants, Anticonvulsants.
- •Patients who are unwilling or unable to comply with the requirements of the protocol.
结局指标
主要结局
At the end of study drug treatment (360 days from start of treatment) in Groups I and II: Increase in Bone Mineral density (BMD) from baseline at Lumbar spine L 1 to L 4.
时间窗: At the end of study drug treatment (360 days from start of treatment)
次要结局
- At the end of study drug treatment (360 days from start of treatment) in Groups I and II :Change in Bone Mineral density (BMD) from baseline at femoral neck and total hip regions. Change from baseline in biomarkers of bone formation and bone resorption. Occurrence of adverse events.(At the end of study drug treatment (360 days from start of treatment))