Status:
COMPLETED
Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women
Lead Sponsor:
Rene Rizzoli
Conditions:
Postmenopause
Eligibility:
FEMALE
45-70 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00372099
Start Date
January 1 2007
End Date
November 1 2011
Last Update
December 23 2011
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