GLP-2 and Bone ResorptionA 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 Resorptio

• Conditions: postmenopausal women with osteopenia (BMD T-score -2.5 < T = -1.0) at one or more of the regions: the lumbar spine, femoral neck or total hip

• Registration Number: EUCTR2005-003076-37-CZ
• Lead Sponsor: Sanos Bioscience A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

•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).
•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?
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

Exclusion Criteria

•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.).
•Tibolone.
•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).
•GLP-2 antibody level >2SD above the normal control mean.
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified