Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2011

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Bone micro-architecture evaluated by high resolution p-QCT
    • Time Frame: 24 months

Secondary Measures

  • Bone turn-over markers
    • Time Frame: 24 months

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 45 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rene Rizzoli
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Rene Rizzoli, Professor – University Hospital, Geneva
  • Overall Official(s)
    • René Rizzoli, Professor, Principal Investigator, Department of Rehabilitation and Geriatrics, University Hospital of Geneva

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