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Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rene Rizzoli, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00372099
First received: September 5, 2006
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Postmenopause
 Drug: Salmon calcitonin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Bone micro-architecture evaluated by high resolution p-QCT [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bone turn-over markers [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: January 2007
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Salmon calcitonin
    nasal salmon calcitonin 200UI/day during 2 years
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372099

Sponsors and Collaborators
Rene Rizzoli
Investigators
Principal Investigator: René Rizzoli, Professor Department of Rehabilitation and Geriatrics, University Hospital of Geneva
  More Information

No publications provided

Responsible Party: Rene Rizzoli, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00372099     History of Changes
Other Study ID Numbers: 05-262/Psy 05-038, CSMC051ACH01
Study First Received: September 5, 2006
Last Updated: December 22, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Postmenopausal women
bone microarchitecture
peripheral quantitative micro-CT
salmon calcitonin

Additional relevant MeSH terms:
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013