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Trial · Interventional

CompletedPhase 3Registry data

Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

NCTNCT00372099 (opens ClinicalTrials.gov in a new tab)Other id05-262/Psy 05-038Other idCSMC051ACH01
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Overview

Status
Completed
Phase
Phase 3
Enrollment
90 participants (actual)
Sponsor
Rene Rizzoli · Other
Design
Randomized · Double masking
Countries
Not stated
Start
Jan 2007
Primary completion
Oct 2011
Completion
Nov 2011
First posted
6 Sept 2006 (estimated)
Last update posted
23 Dec 2011 (estimated)
Conditions
Postmenopause

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009201020112012
  1. Ph 3

    Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

    NCT00372099

    Jan 2007 to Nov 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Salmon calcitoninDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Bone micro-architecture evaluated by high resolution p-QCT

    Time frame · 24 months

Secondary outcomes(1)

  1. Bone turn-over markers

    Time frame · 24 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2008

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.

Richert et al. 2008Trialscited by 2

PMID 18405390PMC2373283DOI 10.1186/1745-6215-9-19PUB-18405390

CC BY
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Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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