A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of osteoporosis in postmenopausal woman taking calcium and vitamin D

• Conditions: The trial is Phase III.The population will be osteoporotic post-menopausal women who are between 55 and 85 years of age; MedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2005-002984-10-LT
• Lead Sponsor: ordic Bioscience

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-11
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 4662

Inclusion Criteria

·Postmenopausal, ambulatory women, between 55 and 85 years old

·A: BMD T-score <=–2.5 at one or more of the following regions: the lumbar spine, femoral neck or total hip, and no more than 2 prevalent mild or moderate vertebral fractures according to the definition of Genant et al (15). No severe fracture is permitted. The inclusion will be defined by the absolute BMD values (g/cm2).

OR

·B: BMD T-score <= –1.5 at one or more of the following regions: the lumbar spine, femoral neck or total hip together with one or two osteoporotic fracture(s) located at the spine according to the definition of Genant et al (15). The inclusion will be defined by the absolute BMD values (g/cm2).

·Ethical criteria - before any study-specific procedure is performed, the appropriate written informed consent must be obtained.

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

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:

oHistory of renal stone
oCurrent hyper- or hypothyroidism. Patients on stable thyroid treatment will be allowed
oCurrent hyper- or hypoparathyroidism
oRheumatoid arthritis
oPaget’s disease
oMalignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
oAny bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
oUntreated or symptomatic malabsorption syndrome
oHeight, weight and girth which may preclude accurate DXA measurements
oAdvanced scoliosis or extensive lumbar fusion which would preclude vertebral fracture assessment
oLess 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.
oScreening 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.
oSerum levels of intact PTH above 68 pg/ml
oCurrent 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).

·The subject has evidence of any heart conduction disorders (this criterion is applicable to Lithuania only by Amendment 3).

·Participants will be excluded from the trial if they have evidence of any new heart conduction disorders (this criterion is applicable to Lithuania only by Amendment 3).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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. <br>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.<br>Exploratory objectives include investigating new bone or cartilage markers that may become available.;Secondary Objective: The secondary objective is to demonstrate the superiority of 0.8 mg of SMC021 relative to placebo on the proportion of study subjects with non-vertebral fractures. <br>;Primary end point(s): The primary efficacy endpoint to be assessed is the number of patients with new vertebral fracture. <br><br>Safety endpoints include adverse events, changes in safety laboratory analyses (serum chemistry, hematology), and number of subjects with antibodies (Yes/No)