The trial is Phase III. The population will be healthy post-menopausal women who are between 55 and 85 years of age MedDRA version: 13.1 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Oral Calcitonin
Product Code: SMC021A
Pharmaceutical Form: Tablet
INN or Proposed INN: calcitonin
CAS Number: 97129
Current Sponsor code: SMC021
Other descriptive name: synthetic calcito
Sponsors
Nordic Bioscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Postmenopausal, ambulatory women, between 55 and 85 years old · A: BMD T-score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Any participant will be excluded from the study, if they have a bone mineral density (BMD) T-score below –4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites. · Any participant will be excluded from the study, if they have more than 2 prevalent vertebral fractures (Genant et al, 15). · If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15). · Participants will be excluded from the study, if they have evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures). A clinical vertebral fracture is defined as vertebral fracture associated with pain or functional disability. · BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip. · Evidence of any of the following from medical history, laboratory results, DXA, or X-ray review: o History of renal stone o Current hyper- or hypothyroidism. Patients on stable thyroid treatment will be allowed o Current hyper- or hypoparathyroidism o Rheumatoid arthritis o Paget’s disease o Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years o Any bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings o Untreated or symptomatic malabsorption syndrome o Height, weight and girth which may preclude accurate DXA measurements o Advanced scoliosis or extensive lumbar fusion which would preclude vertebral fracture assessment o Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA (for the BMD substudy population). Subjects that fulfil the BMD inclusion criteria at the hip, and are not enrolled in the BMD substudy, may be enrolled even if there are not 2 evaluable lumbar vertebrae. o Screening 25 (OH) vitamin D level less than 24 ng/mL (=60 nmol/l). The patient may be treated with 25 (OH) vitamin D3 and serum vitamin D may then be retested. o Serum levels of intact PTH above 68 pg/ml o Current hypocalcaemia (albumin adjusted serum calcium below 2.13 mmol/L [8.5 mg/dL]) · Any organic or psychiatric disorder, or laboratory abnormality which, in the opinion of the Investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results. · Evidence of alcohol or substance abuse that the Investigator believes would interfere with understanding or completing the study. · Subjects with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. · The subject is currently enrolled in a clinical study or at least 30 days have not elapsed since ending other investigational device or drug trial(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the superiority of 0.8 mg of SMC021 relative to placebo on the proportion of study subjects with new vertebral fractures. The primary safety objective is to characterize the safety and tolerability profile of SMC021 in this population based on the adverse event incidence and changes in laboratory profiles. Exploratory objectives include investigating new bone or cartilage markers that may become available.;Secondary Objective: Exploratory objectives include investigating new bone or cartilage markers that may become available.;Primary end point(s): The primary efficacy endpoint to be assessed is the number of patients with new vertebral fracture. Safety endpoints include adverse events, changes in safety laboratory analyses (serum chemistry, hematology), and number of subjects with antibodies (Yes/No) | — |
Countries
Denmark, Estonia, Italy, Lithuania, United Kingdom
Outcome results
None listed