Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

Study Overview
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Brief Summary
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Calcitonin has been used for many years for treating osteoporosis in postmenopausal women. Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent vertebral fractures at baseline.This pilot study should provide additional new insights in the mode of action of nasal calcitonin, on structural changes as measured by high resolution peripheral CT, and on the comparison between weight bearing and non weight bearing bones in postmenopausal women.

Official Title
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Evaluation of the Effects of Salmon Calcitonin Nasal Spray Compared to Placebo on Bone Microarchitecture Measured by High Resolution Peripheral Micro- Computed-tomography Over 2 Years in Postmenopausal Women (a Pilot Study)

Conditions
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Postmenopause

Intervention / Treatment
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* Drug: Salmon calcitonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between age 45-70 Natural or surgical menopause ≥ 1 year T-Score between 0.0 and -2.49 (spine or proximal femur - total or femoral neck measured by DXA) Exclusion Criteria: Osteoporosis (T-score ≤ -2.5 in spine or proximal femur - total or femoral neck, measured by DXA) Severe vertebral fracture, as identified by screening DXA assessment Any history of metabolic disease, which could affect bone metabolism: hyperparathyroidism, osteogenesis imperfecta, Paget's disease, osteomalacia Thyroid disease (if receiving thyroid hormone replacement, the patients must be euthyroid, and on a stable dose of thyroid hormone) Impaired renal function (estimated GFR<30 ml/min) History of previous or active malignancy of any organ system, treated or not treated within the past 5 years. History of corticosteroids treatments during 6 months or more, daily dosage >5 mg . BMI < 18 or >30. Treatments with estrogens, SERMs, tibolone, calcitonin, strontium ranelate, teriparatide or PTH, oral or iv bisphosphonates in the previous year.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Salmon calcitonin|nasal salmon calcitonin 200UI/day during 2 years|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone micro-architecture evaluated by high resolution p-QCT |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone turn-over markers |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal women, bone microarchitecture, peripheral quantitative micro-CT, salmon calcitonin