NCT00525798

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,665

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_3

Geographic Reach
12 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 18, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

4.4 years

First QC Date

September 5, 2007

Results QC Date

September 14, 2012

Last Update Submit

October 22, 2012

Conditions

Osteoporosis

Keywords

Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With New Vertebral Fractures

    The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.

    From baseline to month 36

Secondary Outcomes (1)

  • Number of Patients With Non-vertebral Fractures

    From baseline to month 36

Study Arms (2)

1

ACTIVE COMPARATOR

SMC021 - Oral Calcitonin

Drug: SMC021 Oral calcitonin

SMC021- Placebo

PLACEBO COMPARATOR

SMC021 - placebo

Drug: SMC021 Placebo

Interventions

SMC021 Oral calcitoninDRUG

0.8mg SMC021 - oral calcitonin, once daily

1
SMC021 PlaceboDRUG

SMC021 - Placebo, once daily

SMC021- Placebo

Eligibility Criteria

Age55 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

United Osteporosis Centers

Gainesville, Georgia, 30501, United States

Location

Michigan Bone & Mineral Clinic PC,

Detroit, Michigan, 48236, United States

Location

Oregon Osteoporosis Center

Portland, Oregon, 97213, United States

Location

CCBR Brazil

Rio de Janeiro, 22271-100, Brazil

Location

CCBR China

Beijing, 102206, China

Location

CCBR Czech

Pardubice, 53002, Czechia

Location

CCBR Aalborg

Aalborg, 9000, Denmark

Location

CCBR Ballerup

Ballerup Municipality, 2750, Denmark

Location

CCBR Vejle

Vejle, 7100, Denmark

Location

CCBR Estonia

Tallinn, 10128, Estonia

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

CCBR Hong Kong

Hong Kong, Hong Kong

Location

Department of Internal Medicine, University of Florence

Florence, Italy

Location

CCBR Lithuania

Vilnius, 10323, Lithuania

Location

CCBR Poland

Warsaw, 04703, Poland

Location

CCBR Romania

Bucharest, 030463, Romania

Location

Related Publications (1)

  • 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.

    PMID: 20932224DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Bente Juul Riis
Organization
Nordic Bioscience
bjr@nordicbioscience.com
+45 22901317

Study Officials

  • Bente J Riis, M.D.

    Nordic Bioscience A/S

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 6, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

October 29, 2012

Results First Posted

October 18, 2012

Record last verified: 2012-10

Locations

BR(1)DK(3)HK(1)FR(1)IT(1)US(3)LI(1)ES(1)CN(1)PL(1)CZ(1)RO(1)