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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SMC021 Oral calcitonin
SMC021 Placebo
Sponsored by
Nordic Bioscience A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Other protocol defined inclusion/exclusion criteria may apply

Sites / Locations

  • United Osteporosis Centers
  • Michigan Bone & Mineral Clinic PC,
  • Oregon Osteoporosis Center
  • CCBR Brazil
  • CCBR China
  • CCBR Czech
  • CCBR Aalborg
  • CCBR Ballerup
  • CCBR Vejle
  • CCBR Estonia
  • Hopital Edouard Herriot
  • CCBR Hong Kong
  • Department of Internal Medicine, University of Florence
  • CCBR Lithuania
  • CCBR Poland
  • CCBR Romania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

SMC021- Placebo

Arm Description

SMC021 - Oral Calcitonin

SMC021 - placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients With Non-vertebral Fractures
The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures. Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.

Full Information

First Posted
September 5, 2007
Last Updated
October 22, 2012
Sponsor
Nordic Bioscience A/S
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00525798
Brief Title
A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Official Title
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordic Bioscience A/S
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4665 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
SMC021 - Oral Calcitonin
Arm Title
SMC021- Placebo
Arm Type
Placebo Comparator
Arm Description
SMC021 - placebo
Intervention Type
Drug
Intervention Name(s)
SMC021 Oral calcitonin
Intervention Description
0.8mg SMC021 - oral calcitonin, once daily
Intervention Type
Drug
Intervention Name(s)
SMC021 Placebo
Intervention Description
SMC021 - Placebo, once daily
Primary Outcome Measure Information:
Title
Number of Patients With New Vertebral Fractures
Description
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.
Time Frame
From baseline to month 36
Secondary Outcome Measure Information:
Title
Number of Patients With Non-vertebral Fractures
Description
The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures. Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.
Time Frame
From baseline to month 36

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Other protocol defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente J Riis, M.D.
Organizational Affiliation
Nordic Bioscience A/S
Official's Role
Study Chair
Facility Information:
Facility Name
United Osteporosis Centers
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Michigan Bone & Mineral Clinic PC,
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Oregon Osteoporosis Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
CCBR Brazil
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
CCBR China
City
Beijing
ZIP/Postal Code
102206
Country
China
Facility Name
CCBR Czech
City
Pardubice
ZIP/Postal Code
53002
Country
Czech Republic
Facility Name
CCBR Aalborg
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
CCBR Ballerup
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
CCBR Vejle
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
CCBR Estonia
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CCBR Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Department of Internal Medicine, University of Florence
City
Florence
Country
Italy
Facility Name
CCBR Lithuania
City
Vilnius
ZIP/Postal Code
10323
Country
Lithuania
Facility Name
CCBR Poland
City
Warsaw
ZIP/Postal Code
04703
Country
Poland
Facility Name
CCBR Romania
City
Bucharest
ZIP/Postal Code
030463
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
20932224
Citation
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.
Results Reference
derived

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

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