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

• ClinicalTrials.gov Identifier: NCT00525798
• Recruitment Status: Completed
• First Posted: September 6, 2007
• Results First Posted: October 18, 2012
• Last Update Posted: October 29, 2012
• Sponsor: Nordic Bioscience A/S
• Collaborator: Novartis
• Information provided by (Responsible Party): Nordic Bioscience A/S

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

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 85 Years (Adult, Older Adult)
• Sexes 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.

• Responsible Party: Nordic Bioscience A/S
• ClinicalTrials.gov Identifier: NCT00525798
• Other Study ID Numbers: SMC021A2303
• First Posted: September 6, 2007
• 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:

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Vasodilator Agents