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Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00372099
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Rene Rizzoli, University Hospital, Geneva

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Postmenopause Drug: Salmon calcitonin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : January 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Salmon calcitonin
    nasal salmon calcitonin 200UI/day during 2 years

Outcome Measures
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Primary Outcome Measures :
  1. Bone micro-architecture evaluated by high resolution p-QCT [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Bone turn-over markers [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372099


Sponsors and Collaborators
Rene Rizzoli
Investigators
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Principal Investigator: René Rizzoli, Professor Department of Rehabilitation and Geriatrics, University Hospital of Geneva
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rene Rizzoli, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00372099    
Other Study ID Numbers: 05-262/Psy 05-038
CSMC051ACH01
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011
Keywords provided by Rene Rizzoli, University Hospital, Geneva:
Postmenopausal women
bone microarchitecture
peripheral quantitative micro-CT
salmon calcitonin
Additional relevant MeSH terms:
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Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents