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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525798
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : October 18, 2012
Last Update Posted : October 29, 2012
Information provided by (Responsible Party):
Nordic Bioscience A/S

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: SMC021 Oral calcitonin Drug: SMC021 Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4665 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of Patients With New Vertebral Fractures [ Time Frame: From baseline to month 36 ]

    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 :
  1. Number of Patients With Non-vertebral Fractures [ Time Frame: From baseline to month 36 ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00525798

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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
CCBR Brazil
Rio de Janeiro, Brazil, 22271-100
CCBR China
Beijing, China, 102206
Czech Republic
CCBR Czech
Pardubice, Czech Republic, 53002
CCBR Aalborg
Aalborg, Denmark, 9000
CCBR Ballerup
Ballerup, Denmark, 2750
CCBR Vejle
Vejle, Denmark, 7100
CCBR Estonia
Tallinn, Estonia, 10128
Hopital Edouard Herriot
Lyon, France, 69437
Hong Kong
CCBR Hong Kong
Hong Kong, Hong Kong
Department of Internal Medicine, University of Florence
Florence, Italy
CCBR Lithuania
Vilnius, Lithuania, 10323
CCBR Poland
Warsaw, Poland, 04703
CCBR Romania
Bucharest, Romania, 030463
Sponsors and Collaborators
Nordic Bioscience A/S
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Study Chair: Bente J Riis, M.D. Nordic Bioscience A/S
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nordic Bioscience A/S Identifier: NCT00525798    
Other Study ID Numbers: SMC021A2303
First Posted: September 6, 2007    Key Record Dates
Results First Posted: October 18, 2012
Last Update Posted: October 29, 2012
Last Verified: October 2012
Keywords provided by Nordic Bioscience A/S:
Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Salmon calcitonin
Calcitonin Gene-Related Peptide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents