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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 4500

Inclusion Criteria

·Postmenopausal, ambulatory women, between 60 and 85 years old

·Stratum A (50% of all enrolled subjects): BMD T-score £–2.5 at one or more of the following regions: the lumbar spine, femoral neck or total hip.

OR

·Stratum B (50% of all enrolled subjects): BMD T-score £ –1.5 at one or more of the following regions: the lumbar spine, femoral neck or total hip together with osteoporotic fracture(s) located at the spine according the definition of Genant et al (15).

·Ethical - Before any study-specific procedure, 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

·In different regions of the world different values for the lowest level of BMD T-score and/or number and severity of prevalent vertebral fracture may apply. It will be up to the principal investigator to apply such limits that will satisfy the appropriate local ethical committees or health authorities.

·For stratum A: more than 2 vertebral deformities (Genant et al, 15)

·The presence of clinical vertebral fracture defined as a 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
oScreening 25 (OH) vitamin D level less than 12 ng/mL. The patient may be treated with 50.000 IU oral 25 (OH) vitamin D per day for 2 weeks and serum vitamin D may then be retested. If the level is between 12 and 20 ng/mL, then the subject should be instructed to take at least 800 IU Vitamin D daily.
oSerum levels of intact PTH above 65 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

·Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

·Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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