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Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

NCT ID: NCT00372099

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Postmenopause

Keywords

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Postmenopausal women bone microarchitecture peripheral quantitative micro-CT salmon calcitonin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Salmon calcitonin

nasal salmon calcitonin 200UI/day during 2 years

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rene Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Rene Rizzoli

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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René Rizzoli, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation and Geriatrics, University Hospital of Geneva

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 18405390 (View on PubMed)

Other Identifiers

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CSMC051ACH01

Identifier Type: -

Identifier Source: secondary_id

05-262/Psy 05-038

Identifier Type: -

Identifier Source: org_study_id