CTRI/2022/02/039978招募中未知
Randomized controlled trial comparing the efficacy of teriparatide, zoledronate and denosumab in postmenopausal women with type 2 diabetes mellitus at high risk of fragility fractures: a pilot study.
Postgraduate Institute of Medical Education and Research Chandigarh0 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
- 未知
- 状态
- 招募中
- 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. Ambulatory type 2 diabetes mellitus postmenopausal females
- •2. Age more than or equal to 50 years
- •3. Postmenopausal status for at least 5 years
- •4. Duration of type 2 diabetes mellitus at least 5 years
- •5. Baseline eGFR more than or equal to 45 ml/min/1.73 m2
- •6. Baseline HbA1c 7-10%
- •7. Baseline BMI more than or equal to 23 kg/m2
- •8. Prior vertebral (clinical or morphometric), hip, radius, humerus fragility fracture OR
- •9. Baseline BMD T-score at lumbar spine or femoral neck less than or equal to -2.5 (corrected for T2D) and baseline FRAX score (corrected for T2D) indicating a 10-year probability of hip fracture more than or equal to 2.5% or of major osteoporotic fracture more than or equal to 9%.
- •10. Those willing to give informed consent
排除标准
- •1. Type 1 diabetes mellitus or latent autoimmune diabetes in adults, or secondary diabetes mellitus
- •2. Prior history of use of bone-active therapies (bisphosphonates, teriparatide, denosumab, selective estrogen receptor modulators, hormone replacement therapies, calcitonin)
- •3. Prior history of glucocorticoid use at a dose more than or equal to 15 mg (prednisolone or equivalent) for more than or equal to 3 months.
- •4. History of use of pioglitazone, thiazides, or canagliflozin over last 6 months
- •5. Hyperthyroidism (overt/subclinical) or overt hypothyroidism (detected during baseline screening)
- •6. History of hypoparathyroidism or primary hyperparathyroidism
- •7. History of acromegaly
- •8. History of Addison disease or Cushingââ?¬•s syndrome
- •9. History of gonadal insufficiency (primary or secondary)
- •10. History of hypercalcemia (or detected during baseline screening)
- •11. Elevated hepatic transaminase levels more than or equal to 3 times upper limit of normal (detected during baseline screening)
- •12. Any solid organ or bone marrow transplant
- •13. History of any active or past malignancy
- •14. History of gastrointestinal disorders and malabsorption states, namely, celiac disease (also screened at baseline), inflammatory bowel disease, chronic hepatitis, bowel resection, chronic liver disease, gastrectomy, lactose intolerance
- •15. History of bone marrow related disorders, namely, leukemia, lymphoma, hemochromatosis, multiple myeloma (also screened at baseline), sarcoidosis, sickle cell anemia, thalassemia, amyloidosis
- •16. History of rheumatological disorders, namely, rheumatoid arthritis, ankylosing spondylitis, Marfans syndrome, Ehler-Danlos syndrome
- •17. History of any condition that may affect bone metabolism, namely, Pagetââ?¬•s disease, osteopetrosis, osteogenesis imperfecta, hypophosphatasia
- •18. History of recent tooth extraction (within 6 months of screening)
研究者
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