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

- Drug: Salmon calcitonin
nasal salmon calcitonin 200UI/day during 2 years
- Bone micro-architecture evaluated by high resolution p-QCT [ Time Frame: 24 months ]
- Bone turn-over markers [ Time Frame: 24 months ]

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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 |
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.

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
Principal Investigator: | René Rizzoli, Professor | Department of Rehabilitation and Geriatrics, University Hospital of Geneva |
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 |
Postmenopausal women bone microarchitecture peripheral quantitative micro-CT salmon calcitonin |
Calcitonin Salmon calcitonin Calcitonin Gene-Related Peptide Katacalcin |
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