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

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: SMC021 Oral calcitonin; Drug: SMC021 Placebo

• Registration Number: NCT00525798
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-05
• Study First Submitted QC: 2007-09-05
• Study First Posted: 2007-09-06
• Primary Completion: 2011-08
• Study Completion: 2011-11
• Results First Submitted: 2012-09-14
• Results First Submitted QC: 2012-09-14
• Status Verified: 2012-10
• Results First Posted: 2012-10-18
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4665

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SMC021 Oral calcitonin	SMC021 - Oral Calcitonin
SMC021- Placebo	SMC021 Placebo	SMC021 - placebo

Primary Outcome Measures

Name	Time	Method
Number of Patients With New Vertebral Fractures	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

Name	Time	Method
Number of Patients With Non-vertebral Fractures	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.

Trial Locations

Locations (16)

CCBR Lithuania; 🇱🇹 Vilnius, Lithuania

CCBR Estonia; 🇪🇪 Tallinn, Estonia

Department of Internal Medicine, University of Florence; 🇮🇹 Florence, Italy

United Osteporosis Centers; 🇺🇸 Gainesville, Georgia, United States

CCBR China; 🇨🇳 Beijing, China

Hopital Edouard Herriot; 🇫🇷 Lyon, France

CCBR Poland; 🇵🇱 Warsaw, Poland

CCBR Brazil; 🇧🇷 Rio de Janeiro, Brazil

CCBR Aalborg; 🇩🇰 Aalborg, Denmark

CCBR Ballerup; 🇩🇰 Ballerup, Denmark

CCBR Vejle; 🇩🇰 Vejle, Denmark

Michigan Bone & Mineral Clinic PC,; 🇺🇸 Detroit, Michigan, United States

Oregon Osteoporosis Center; 🇺🇸 Portland, Oregon, United States

CCBR Czech; 🇨🇿 Pardubice, Czech Republic

CCBR Romania; 🇷🇴 Bucharest, Romania

CCBR Hong Kong; 🇭🇰 Hong Kong, Hong Kong