EUCTR2010-024150-10-BG进行中（未招募）不适用
A-15 week, double-blind, randomized, active-controlled, multicenter study to evaluate the efficacy and safety of Alendronate plus Vitamin D3 in women with osteoporosis - Vit.D levels after alendronate plus vitamin D3 in postmenopausal women
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 630
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. 18 years and older
- •2. Patients in good general health, according to the investigator?s judgment
- •3. Serum 25-hydroxy vitamin D =9 ng/ml
- •4. Normal (within reference range) iPTH and BSAP for patients with serum 25-hydroxy vitamin D =9 ng/ml and <15 ng/ml
- •5. Postmenopausal women defined as one of the following: - more than 6 months amenorrhea in patients =55 years OR - more than 18 months amenorrhea in patients <55 years OR - baseline serum FSH >35 IU/l in patients <55 years and less than 18 months amenorrhea OR - surgical menopause since more than 4 weeks.
- •6. Recent (within the last 6 months) bone mineral density (BMD) Tscore determined by dual energy X-ray absorptiometry (DEXA) of either lumbar spine or hip of = -2.5 (=2.5 standard deviations below the mean for normal postmenopausal women)
- •7. Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
- •8. Patient agrees to avoid tanning beds/UV therapy within 14 days of study start, and during the study
- •9. Patients with ability to follow study instructions and likely to attend and complete all required visits
- •10. Written informed consent of the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 630
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 630
排除标准
- •1. Hypersensitivity to the active substances or to any of the excipients, or to any related drug
- •2. Bone fractures within 3 months prior to screening
- •3. Inability to stand or sit upright for at least 30 minutes
- •4. Inability to take the study drugs as recommended: after getting up for the day with a full glass of water (not less than 200 ml)
- •5. Active upper gastrointestinal problems, such as dysphagia, esophageal disease, gastritis, duodenitis, ulcers
- •6. Recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty
- •7. Known Barrett's esophagus
- •8. Malabsorption
- •9. Hypocalcemia: serum calcium <2.1 mmol/l (9 mg/dl)
- •10. Concomitant malignancy except carcinoma in situ not needing other than local therapy
- •11. History of solid tumors not curatively treated or showing a recurrence within the last 5 years
- •12. Concomitant untreated severe periodontal disease
- •13. Renal impairment (glomerular filtration rate less than 35 ml/min)
- •14. Presence of bone or mineral metabolism disorders, other than idiopathic osteoporosis (e.g. hyperparathyroidism, hyperthyroidism, osteomalacia of other origin, Paget?s disease of bone, glucocorticoid-induced osteoporosis)
- •15. Diseases associated with unregulated overproduction of calcitriol (e.g. leukemia, lymphoma, sarcoidosis).
- •16. Previous or concomitant intake of drugs and/or food additives restricted by the protocol (for a complete list please see chapter 8.6.6, page 38).
- •17. Pregnancy or lactation
- •18. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
- •19. Severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol
- •20. History of alcohol or drug addiction
- •21. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
- •22. Unreliability or lack of cooperation
研究者
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