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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525798
• Other study ID #: SMC021A2303
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2007
• Last updated: October 22, 2012
• Start date: March 2007
• Est. completion date: November 2011

Study information

• Verified date: October 2012
• Source: Nordic Bioscience A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyEstonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsCzech Republic: State Institute for Drug ControlRomania: National Medicines AgencyBrazil: Ministry of HealthHong Kong: Department of HealthChina: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4665
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• SMC021 Oral calcitonin
0.8mg SMC021 - oral calcitonin, once daily
• SMC021 Placebo
SMC021 - Placebo, once daily

Locations

Country	Name	City	State
Brazil	CCBR Brazil	Rio de Janeiro
China	CCBR China	Beijing
Czech Republic	CCBR Czech	Pardubice
Denmark	CCBR Aalborg	Aalborg
Denmark	CCBR Ballerup	Ballerup
Denmark	CCBR Vejle	Vejle
Estonia	CCBR Estonia	Tallinn
France	Hopital Edouard Herriot	Lyon
Hong Kong	CCBR Hong Kong	Hong Kong
Italy	Department of Internal Medicine, University of Florence	Florence
Lithuania	CCBR Lithuania	Vilnius
Poland	CCBR Poland	Warsaw
Romania	CCBR Romania	Bucharest
United States	Michigan Bone & Mineral Clinic PC,	Detroit	Michigan
United States	United Osteporosis Centers	Gainesville	Georgia
United States	Oregon Osteoporosis Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Nordic Bioscience A/S	Novartis

Countries where clinical trial is conducted

United States,  Brazil,  China,  Czech Republic,  Denmark,  Estonia,  France,  Hong Kong,  Italy,  Lithuania,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	From baseline to month 36	No