EUCTR2005-003076-37-DK进行中（未招募）不适用
GLP-2 and Bone Resorption. A double-blind, randomized, placebo-controlled, dose ranging, safety, tolerability and pharmacokinetic/dynamic efficacy study with multiple subcutaneous injections of GLP-2 in postmenopausal female volunteers.120 Days of Treatment - GLP-2 and Bone Resorption
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •·Postmenopausal women age 55-75 who have been postmenopausal for at least 5 years since their last menstrual cycle.
- •·Signed informed consent before any study specific procedure is performed.
- •·BMD T-score between -2.5 < T = -1.0 at one or more of the regions: lumbar spine, femoral neck or total hip.
- •·Bone turnover assessed by measuring s-CTX. Reference range for this parameter is: s-CTX (0.439-1.351 ng/ml for Serum CrossLaps One Step ELISA and 0.504-1.224 ng/ml for Serum CTX Elecsys).
- •·Non-obese with a BMI between 20.0-30.0 kg/m2.
- •·Good physical and mental condition.
- •·In the Investigator’s opinion, the subject is able to comply with the protocol and complete the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·BMD T-score > -1.0 at all the regions: lumbar spine, femoral neck and total hip.
- •·BMD T-score = -2.5 at any of the regions: lumbar spine, femoral neck and total hip.
- •Chronic administration of any prescription medication known to influence bone metabolism or the gastrointestinal system within the last 6 months:
- •·Estrogens (also combined estrogen-progestin therapy).
- •·SERMs (e.g. raloxifene, basedoxifene, tamoxifene, etc.).
- •·Calcitonin.
- •·Vitamin D supplements in excess of 2000 IU daily.
- •·PTH 1-34, 1-84, or other PTH fragments/analogs.
- •·Anabolic steroids (natural and synthetic androgens, e.g. testosterone, nandrolone, mesterolon etc.).
- •·Systemic glucocorticoids (local glucocorticoids are acceptable).
- •·Remicade (infliximab)
- •·Interferon and antiviral medication
- •·Antiepileptics (e.g. valproate, phenytoin, primidon, tiagabin, etc.).
- •·Azathioprin
- •·Sandostatin
- •·Bisphosphonates (oral and intravenous):
- •–if used more than 3 years, then subject cannot be included.
- •–if used less than 3 years and last dose less than 1 year ago, then subject cannot be included.
- •–if used less than 3 months and last dose more than 1 year ago, then subject may be included.
- •·Strontium or fluoride (oral or intravenous) within the last 3 years
- •·History or evidence of any diseases known to influence bone or calcium metabolism. Potential alterations in bone turnover and calcium-regulating hormones will be assessed objectively by measuring PTH and vitamin D, respectively. Reference ranges for these parameters are: PTH (15.00 - 65.00 pg/ml) and vitamin D (47.7 - 144.0 nmol/l).
- •·Gastrointestinal diseases and major operations in the gastrointestinal tract.
- •·Secondary osteoporosis (osteoporosis due to other underlying conditions, such as metastasis, hyperthyroidism, hyperparathyroidism, chronic treatment with glucocorticoids).
- •·Paget’s disease of bone.
- •·Hypothyroidism.
- •·Hypoparathyroidism.
- •·Hypocalcaemia (albumin adjusted serum calcium below 2.13 mmol/L, (8.5 mg/dl))
- •·Rheumatoid arthritis.
- •·Dermatomyositis.
- •·Other metabolic bone disease (rickets and osteomalacia).
- •·Genetic and dysplastic disorders (e.g. osteogenesis imperfecta, fibrous dysplasia, chondrodystrophy).
- •·Any renal diseases causing impaired renal function as determined by s-creatinine > 0.12 mmol/l.
- •·Any hepatic disease causing increases in serum concentrations of ASAT or ALAT more than x 2 the normal upper range values.
- •·Diabetes mellitus.
- •·Malignancy within the last 10 years, except for skin cancer (basal cell carcinoma).
- •·Alcohol or drug abuse.
- •·Any clinically significant findings, which the Investigator considers a potential source of complications for the subject.
研究者
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