Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

Rene Rizzoli

Status and phase

Completed

Phase 3

Conditions

Postmenopause

Treatments

Drug: Salmon calcitonin

Study type

Interventional

Funder types

Other

Identifiers

NCT00372099

05-262/Psy 05-038

CSMC051ACH01

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

Female

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.