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Table 1 In- and exclusion criteria

From: A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women — Study protocol

Inclusion criteria

• Women aged 45 to70 years

• 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 that 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 creatinine clearance <30 ml/min)

• History of previous or active malignancy of any organ system, treated or untreated, within the past 5 years.

• History of corticosteroid treatments during 6 months or more, daily dosage >5 mg

• BMI < 18 or >30 kg/m2

• Treatments with estrogens, SERMs, tibolone, calcitonin, strontium ranelate, teriparatide or PTH, or oral bisphosphonates in the previous year, if duration > 2 weeks. Treatment with iv bisphosphonates or iv calcitonin of any duration in the previous year