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.
Conditions
Interventions
Product Name: Glucagon-like peptide-2
Product Code: GLP-2
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo:
Sponsors
Sanos Bioscience A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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). · 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the efficacy of 3 different (200 µg, 1600 µg, 3200 µg) daily doses of a subcutaneous injection of GLP-2 on biochemical markers of bone turnover as compared to placebo treatment and whether there will be a favourable effect on net bone mineral density (BMD) between the GLP-2 and placebo treated women. Another objective is to evaluate the safety and tolerability of the tested doses during the 120-day treatment period as compared with placebo treatment. Furthermore, the clinical optimal dose(s) will be selected for the next phase of the clinical development;Secondary Objective: ;Primary end point(s): The primary efficacy endpoints of the study are the change in s-CTX following injection of GLP-2 versus placebo. Additionally, the study intends to clarify whether the 120 day treatment with GLP-2 will give rise to any change in BMD at the spine over the 120 days, both within groups and between groups. The primary safety endpoint of the study is that no serious adverse events can be related to the administration of GLP-2. | — |
Countries
Czech Republic, Denmark
Outcome results
None listed