Treatment of bone loss and changes in bone architecture in osteopenic patients with Crohn's disease: a comparison between calcium supplementation and vitamin D alone or combined with oral risedronate 35 mg once weekly

Aventis (The Netherlands)0 个研究点目标入组 130 人开始时间: 2005年12月20日最近更新: 2021年8月30日

适应症

试验速览

2013 Results article in https://gut.bmj.com/content/63/9/1424 (added 20/08/2021)

•1. Men and women between 18 and 70 years of age
•2. Patients suffering from Crohn's disease of at least three months duration, confirmed by radiography, endoscopy and histology
•3. Quiescent stage of disease as defined by the Crohn's Disease Activity Index (CDAI less than 150)
•4. A Bone Mineral Density (BMD) between -1.0 SD and -2.5 SD as assessed by Dual Energy X-ray Absorptiometry (DEXA) (T-score) of lumbar spine or total hip
•5. A serum 25(OH)-vitamin D level more than 25 nmol/L
•6. Patients must be able to adhere to the study visit schedule and protocol requirements
•7. Patients must be able to give informed consent and the consent must be obtained prior to any study procedures

•1. Patients with a DEXA T-score less than -25 in lumbar spine or total hip
•2. Patients who have received bisphosphonates a year prior to inclusion, or who are known with an allergy to bisphosphonates
•3. Patients who have received calcitonin or suppressive doses of thyroxine within one year
•4. Patients with serum 25(OH)-vitamin D levels less than 25 nmol/L (supplementation for three months prior to (renewed) screening is allowed)
•5. Corticosteroid treatment three months prior to screening or during the screening phase with daily dosages above 75 mg prednisole-equivalent at any time
•6. A history of hyperthyroidism, Paget's disease or other metabolic bone diseases, Cushing's disease or hyperprolactinemia
•7. Female patients who are pregnant or breast-feeding
•8. Patients receiving hormonal replacement therapy
•9. A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study

发起方

Aventis (The Netherlands)