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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S
ClinicalTrials.gov Identifier:
NCT00525798
First received: September 5, 2007
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: SMC021 Oral calcitonin
Drug: SMC021 Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nordic Bioscience A/S:

Primary Outcome Measures:
  • Number of Patients With New Vertebral Fractures [ Time Frame: From baseline to month 36 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to month 36 ] [ Designated as safety issue: No ]

    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.



Enrollment: 4665
Study Start Date: March 2007
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
SMC021 - Oral Calcitonin
Drug: SMC021 Oral calcitonin
0.8mg SMC021 - oral calcitonin, once daily
Placebo Comparator: SMC021- Placebo
SMC021 - placebo
Drug: SMC021 Placebo
SMC021 - Placebo, once daily

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525798

Locations
United States, Georgia
United Osteporosis Centers
Gainesville, Georgia, United States, 30501
United States, Michigan
Michigan Bone & Mineral Clinic PC,
Detroit, Michigan, United States, 48236
United States, Oregon
Oregon Osteoporosis Center
Portland, Oregon, United States, 97213
Brazil
CCBR Brazil
Rio de Janeiro, Brazil, 22271-100
China
CCBR China
Beijing, China, 102206
Czech Republic
CCBR Czech
Pardubice, Czech Republic, 53002
Denmark
CCBR Aalborg
Aalborg, Denmark, 9000
CCBR Ballerup
Ballerup, Denmark, 2750
CCBR Vejle
Vejle, Denmark, 7100
Estonia
CCBR Estonia
Tallinn, Estonia, 10128
France
Hopital Edouard Herriot
Lyon, France, 69437
Hong Kong
CCBR Hong Kong
Hong Kong, Hong Kong
Italy
Department of Internal Medicine, University of Florence
Florence, Italy
Lithuania
CCBR Lithuania
Vilnius, Lithuania, 10323
Poland
CCBR Poland
Warsaw, Poland, 04703
Romania
CCBR Romania
Bucharest, Romania, 030463
Sponsors and Collaborators
Nordic Bioscience A/S
Novartis
Investigators
Study Chair: Bente J Riis, M.D. Nordic Bioscience A/S
  More Information

No publications provided by Nordic Bioscience A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nordic Bioscience A/S
ClinicalTrials.gov Identifier: NCT00525798     History of Changes
Other Study ID Numbers: SMC021A2303
Study First Received: September 5, 2007
Results First Received: September 14, 2012
Last Updated: October 22, 2012
Health Authority: Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control
Romania: National Medicines Agency
Brazil: Ministry of Health
Hong Kong: Department of Health
China: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Nordic Bioscience A/S:
Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Salmon calcitonin
Calcitonin
Vitamin D
Calcitonin Gene-Related Peptide
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014