Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women
This study has been completed.
Information provided by (Responsible Party):
Rene Rizzoli, University Hospital, Geneva
First received: September 5, 2006
Last updated: December 22, 2011
Last verified: December 2011
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.
Drug: Salmon calcitonin
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||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)
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||45 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00372099
||René Rizzoli, Professor
||Department of Rehabilitation and Geriatrics, University Hospital of Geneva
No publications provided
||Rene Rizzoli, Professor, University Hospital, Geneva
History of Changes
|Other Study ID Numbers:
||05-262/Psy 05-038, CSMC051ACH01
|Study First Received:
||September 5, 2006
||December 22, 2011
Keywords provided by University Hospital, Geneva:
peripheral quantitative micro-CT
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs