Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00372099

First Posted: September 6, 2006

Last Update Posted: December 23, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Rene Rizzoli, University Hospital, Geneva

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 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)

Resource links provided by NLM:

Drug Information available for: Calcitonin Salmon calcitonin

U.S. FDA Resources

Further study details as provided by Rene Rizzoli, University Hospital, Geneva:

Primary Outcome Measures:

Bone micro-architecture evaluated by high resolution p-QCT [ Time Frame: 24 months ]

Secondary Outcome Measures:

Bone turn-over markers [ Time Frame: 24 months ]


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:

nasal salmon calcitonin 200UI/day during 2 years

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years to 70 Years (Adult, Senior)
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

Information from the National Library of Medicine

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


Principal Investigator:	René Rizzoli, Professor	Department of Rehabilitation and Geriatrics, University Hospital of Geneva

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
First Submitted:	September 5, 2006
First Posted:	September 6, 2006
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:


Salmon calcitonin Calcitonin Calcitonin Gene-Related Peptide	Bone Density Conservation Agents Physiological Effects of Drugs Vasodilator Agents

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