Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

Study Description

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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.

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

Study Design

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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

Arms and Interventions

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Intervention Details:

Drug: Salmon calcitonin
nasal salmon calcitonin 200UI/day during 2 years

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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Sponsors and Collaborators

Rene Rizzoli

Investigators

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

More Information

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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 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