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Trial record 14 of 232 for:    CALCITONIN SALMON

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

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 6, 2006
Last Update Posted Date December 23, 2011
Study Start Date  ICMJE January 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Bone micro-architecture evaluated by high resolution p-QCT [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
Bone micro-architecture evaluated by high resolution p-QCT
Change History Complete list of historical versions of study NCT00372099 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Bone turn-over markers [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
Bone turn-over markers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postmenopause
Intervention  ICMJE Drug: Salmon calcitonin
nasal salmon calcitonin 200UI/day during 2 years
Study Arms  ICMJE Not Provided
Publications * Richert L, Uebelhart B, Engelhardt M, Azria M, Rizzoli R. A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women - study protocol. Trials. 2008 Apr 13;9:19. doi: 10.1186/1745-6215-9-19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2010)
90
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00372099
Other Study ID Numbers  ICMJE 05-262/Psy 05-038
CSMC051ACH01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rene Rizzoli, University Hospital, Geneva
Study Sponsor  ICMJE Rene Rizzoli
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: René Rizzoli, Professor Department of Rehabilitation and Geriatrics, University Hospital of Geneva
PRS Account University Hospital, Geneva
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP