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A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

NCT ID: NCT00525798

Last Updated: 2012-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4665 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis

Detailed Description

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Conditions

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Osteoporosis

Keywords

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Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

SMC021 - Oral Calcitonin

Group Type ACTIVE_COMPARATOR

SMC021 Oral calcitonin

Intervention Type DRUG

0.8mg SMC021 - oral calcitonin, once daily

SMC021- Placebo

SMC021 - placebo

Group Type PLACEBO_COMPARATOR

SMC021 Placebo

Intervention Type DRUG

SMC021 - Placebo, once daily

Interventions

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SMC021 Oral calcitonin

0.8mg SMC021 - oral calcitonin, once daily

Intervention Type DRUG

SMC021 Placebo

SMC021 - Placebo, once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.

Exclusion Criteria

* BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
* More than 2 prevalent vertebral fractures (Genant et al, 15).
* If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
* Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
* BMD T-score \> -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Nordic Bioscience A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bente J Riis, M.D.

Role: STUDY_CHAIR

Nordic Bioscience A/S

Locations

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United Osteporosis Centers

Gainesville, Georgia, United States

Site Status

Michigan Bone & Mineral Clinic PC,

Detroit, Michigan, United States

Site Status

Oregon Osteoporosis Center

Portland, Oregon, United States

Site Status

CCBR Brazil

Rio de Janeiro, , Brazil

Site Status

CCBR China

Beijing, , China

Site Status

CCBR Czech

Pardubice, , Czechia

Site Status

CCBR Aalborg

Aalborg, , Denmark

Site Status

CCBR Ballerup

Ballerup Municipality, , Denmark

Site Status

CCBR Vejle

Vejle, , Denmark

Site Status

CCBR Estonia

Tallinn, , Estonia

Site Status

Hopital Edouard Herriot

Lyon, , France

Site Status

CCBR Hong Kong

Hong Kong, , Hong Kong

Site Status

Department of Internal Medicine, University of Florence

Florence, , Italy

Site Status

CCBR Lithuania

Vilnius, , Lithuania

Site Status

CCBR Poland

Warsaw, , Poland

Site Status

CCBR Romania

Bucharest, , Romania

Site Status

Countries

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United States Brazil China Czechia Denmark Estonia France Hong Kong Italy Lithuania Poland Romania

References

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Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11.

Reference Type DERIVED
PMID: 20932224 (View on PubMed)

Other Identifiers

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SMC021A2303

Identifier Type: -

Identifier Source: org_study_id