Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

Postmenopause Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372099
• Other study ID #: 05-262/Psy 05-038
• Secondary ID: CSMC051ACH01
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2006
• Last updated: December 22, 2011
• Start date: January 2007
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• Salmon calcitonin
nasal salmon calcitonin 200UI/day during 2 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rene Rizzoli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone micro-architecture evaluated by high resolution p-QCT		24 months	Yes
Secondary	Bone turn-over markers		24 months	Yes